An Official Publication of Indian Dental Association, Ludhiana ...

Vol. 1 Issue 11 L.E.D. E-Journal

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L.E.D. E-Journal November 2016 Vol. 1 Issue 11

Contents Index

S. No.

Title Details Page No. From–To

1. Introduction Welcome 5 – 8 Basic Info & Contact Us

5 – 7

Mission & Vision 8 2. Insight into the Journal Information 9 3. Advisory & Editorial Board The Stalwarts 10 – 11 4. Feedback Suggestions 12 5. From the Editor’s Desk Dr. Bhavdeep

Singh Ahuja 13 – 22

6. CBCT in Endodontics – Aboon for effective treatment

and cure

Dr. Edwin Roberto Hernandez Molina

24 – 40

7. Sialolithiasis of Submandibular Gland duct

– A Rare Case Report

Dr. S.P.S. Sodhi, Dr. Gursimrat Kaur Brar & Dr. Dikshit

Behal

42 – 52

8. Power Scaling – Boon orBane – Part III

Dr. Ajay Kakar 54 – 60

9. Early Infancy Teeth – ACase Report

Dr. Parajeeta Dikshit & Dr.

Senchhema Limbu

62 – 69

10. Ridge Split Technique andBone Expansion Osteotomy

– For SuccessfulRehabilitation

Dr. Abhijeet Bhasin

71 – 82

11. Photodontics – Part XIIntroduction to the World

of Lenses – An Enigma or a Reality

Dr. Mayur Davda 84 – 94

12. Infections resulting fromBone Graft Materials – A

Review

Dr. Rita Singh, Dr. Lanka Mahesh &

Dr. Sagrika Shukla

96 – 106

13. Efficacy of 980nm DiodeLaser as an adjunct to

Stannous Fluoride in the management of Dentinal

Hypersensitivity – A controlled prospective

clinical study

Dr. Rajeev Ranjan 108 – 120

14. Radix Entomolaris inPermanent Mandibular

First Molar – An Endodontic Challenge – A

Dr. Meenu Bhola, Dr. Geetika Jindal & Dr. Aashana Goel

122 – 129


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Case Report 15. Nanodentistry – A Novel

Approach Dr. Parminder

Singh Grover & Dr. Supreet Kapoor

131 – 135

16. Managing Better – An Art and a Science – Part XI

Dr. Bhavdeep Singh Ahuja

137 – 142

17. Feedback Prize Winning 144 18. Manuscripts Invited For Publishing 147 19. Appendices E-Journal 148 – 411

Author Guidelines For Publishing 150 – 154 DCI - Revised Code of

Ethics Dental Council of

India 155 – 165

DCI – Right to Information - Handbook

Dental Council of India

166 – 191

DCI – Establishment Scheme for Opening of New

Dental Colleges


192 – 196

WHO Guidelines on Dengue & Chikungunya

World Health Organization

197 – 227

Dental Trauma Guidelines – Revised

International Association of

Dental Traumatology

228 – 254

Revised Bio Medical Waste Management Rules 2016

Govt. of India Gazette Notification

255 – 292

Introduction and Guidelines for Starting a Diagnostic Installation

AERB - Atomic Energy Regulatory

Board

293 – 296

Revised Guidelines for obtaining Regulatory

Consents for Diagnostic Equipment


Board

297 – 299

Guidelines for shielding of X-ray Installations


Board

300 – 303

Guidelines for applying for License Diagnostic

Radiology Equipment


Board

304 – 329

Checklist for submission of application form for

registration


Board

330 – 335

National Treatment Guidelines for

Antimicrobial Use

Antibiotics in Infectious Diseases

336 – 399

Registration and Import of Medical Devices in India –

Frequently Asked Questions

Central Drugs Standard Control

Organization

400 – 411


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Happy GURPURAB


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L.E.D. E–Journal

Let’s Enjoy Dentistry, Ludhiana

The August Voice of Dentiana L.E.D. E–Journal is the Official Monthly Publication of IDA (Indian Dental Association) Ludhiana Branch, launched w.e.f. 1st January, 2016. L.E.D. stands for Let’s Enjoy Dentistry. The name has no direct reference to any individual, corporate, society etc. and is just a means to inform and enlighten about the visual dentistry amongst dental professionals & in particular, the IDA Members through this medium. The contents in the ‘L.E.D. E–Journal’ is for information purposes only. It is the users’ discretion to follow the path & procedures enlisted within, blindly or under proper guidance or using their own wit & judgment and IDA Ludhiana holds no responsibility for the same. ‘L.E.D. E–Journal’ is the August Voice of Dentiana, where the word ‘Dentiana’ is a short combined word for Dental (Dentists of) + Ludhiana. The Name ‘L.E.D. E–Journal’, ‘Dentiana’ and the Logo are copyrighted properties of IDA (Indian Dental Association) Ludhiana Branch. The contents remain the property of the copyright owner & all rights are reserved. Any misuse of the name & logo for any purpose and without valid permissions from the Editor, Publisher or IDA Ludhiana Branch shall make the user at risk of violation under copyright laws. Published & Printed by: Dr. Bhavdeep Singh Ahuja on

behalf of IDA Ludhiana Branch

Owned by: IDA Ludhiana Branch

IDA Ludhiana Email: [email protected]

IDA Ludhiana Websites & Mirror Links: www.idaludhiana.org, www.idaludhiana.com, www.ludhianaida.com

Editor-in-Chief: Dr. Bhavdeep Singh Ahuja

Editorial Office: Dr. Bhavdeep Singh Ahuja, c/o Dr. Ahuja’s Dentech Smiles Dental Clinic & Implant Centre, # 363-B, B.R.S. Nagar, Main Road, Ludhiana – 141 012 Punjab INDIA Tel: +91 161 5099 039 Mobile: + 91 98761 93039 Website: www.drbhavdeep.com (E-Journal available here also) Email: [email protected]


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Templates Design: Nishtha Computers, Satya Printing, Creative Publishing, Raju Cyber Print & Gagan Printing. Templates Final Binding & Design: Creative Publishing House & Raju Cyber Print. Cover Page Design: Big Ideas Inc. Cover Page Conceptualized, Designed & Compiled by: Dr. Bhavdeep Singh Ahuja Creative Framework & Lay out: Dr. Bhavdeep Singh Ahuja, Dr. Navjot Singh Khurana & Dr. Manjot Singh

Copyright©2016 by IDA Ludhiana All rights reserved. No part of this publication may be reposted, reproduced, reprinted, transmitted or otherwise used in any form or by any means, electronic or mechanical, without the express written permission from the Editor/Publisher. The opinions expressed in the articles and advertisements are those of the authors/companies/ dealers and don’t necessarily reflect those of the Editor or Publisher or the Members of the Editorial or Advisory Board of L.E.D. E–Journal. IDA Ludhiana makes every effort to report clinical information and manufacturer’s product news accurately but cannot assume responsibility for the validity of product claims or for typographical errors. The publisher also does not assume responsibility for product names, claims or statements made by advertisers. The views & opinions expressed by authors/companies/dealers published in L.E.D. E–Journal are their own and do not necessarily reflect the policy or position of the Editor or Publisher or the Members of the Editorial or Advisory Board of L.E.D. E–Journal. This E-Journal is sent free of charge to IDA Ludhiana Branch Members via their email and for others; it is available for free download from www.idaludhiana.org, www.idaludhiana.com & from the Editor’s personal website www.drbhavdeep.com (as a tribute to IDA Ludhiana Branch). Acknowledgments The Gyaan snippets & Images have been copied from www.ida.org.in in the L.E.D. E–Journal by IDA Ludhiana, being a small tributary of the big river, the IDA Head Office with the sole aim of creating awareness of IDA Head office activities through an entertaining mode. P.S. It is essential to read this E–Journal under a screen resolution of 1600 x 1200 dpi or more, and preferably on a 17" or bigger monitor (as it contains several tables and high resolution graphics). If the resolution is less than this, you may see broken or overlapping tables/graphics, graphics overlying text or other anomalies. It is strongly advised to switch over to this resolution to read this E–Journal. These pages are viewed best in Internet Explorer 8 and above, Google Chrome etc. The IDA Ludhiana website has been constructed and maintained by IDA Ludhiana Branch. You may want to give me the feedback to make this E–Journal better. Please be kind enough to write your comments/feedback/ suggestions & email it to the Editor, Dr. Bhavdeep S. Ahuja through [email protected]. These feedbacks would help us grow further & become better.


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About L.E.D.: L.E.D. Journal, a multi-specialty & peer reviewed journal coming out every month Online, free & Print on demand and is a compilation of articles, case reports, research reviews etc. published to provide a platform for the presentation and criticism of interesting, innovative and thought provoking ideas in dentistry. L.E.D. Journal is open to publish new, challenging and radical ideas, along with re-publishing of any old but contemporary ideas as long as they are logical, rational, coherent and reasonably expressed. The re-publishing of the old cases would be however, done with the prior permission & consent of the Author & the Publisher and with proper acknowledgment to both in the contribution itself. The main idea behind publishing not only new but old & interesting cases is that India is a diverse country with varied cultural & geographical distributions. Just to quote an example here, that many a times, an interesting case report or a dynamic study presented in Kerala (South) in a Print Journal might not have its far spread reach in Punjab (North). We would like to keep the number of articles around to 10-12 per issue. We would also like L.E.D. Journal to be a medium for discussing varied issues like ethics in dentistry, Informed consent, Medico-Legal issues in Dentistry etc. as well. It is also indented to present this as a form suitable to the general practitioner. The journal’s full text will be available online free at http://www.idaludhiana.org, http://www.idaludhiana.com & on the Editor’s personal website http://www.drbhavdeep.com. The E-Journal allows free access (Open Access) to its contents. The Print Version of L.E.D. Journal, however, would be available on demand for the Authors at a nominal payment. Submitted papers must be in technical English, suitable for scientific publication. All articles submitted will be passed on to the Members of the Editorial Board and will be peer reviewed by them. Receipt of the manuscript will be acknowledged by email. Every effort will be made to complete the review process within 2-4 weeks and communicated to the corresponding author. The Editorial board will strive for the quality and also will try for indexing the journal in various indexing bodies and if successful, the information will be updated on the IDA Ludhiana website from time to time. We welcome all of you and we hope you will consider L.E.D. Journal for your next submission. Papers should be submitted to the Editor, Dr. Bhavdeep Singh Ahuja @ [email protected].

Mission & Vision: The Mission of L.E.D. Journal is to serve as a platform for stimulating, guiding, motivating & support young upcoming dentists to rub shoulder to shoulder with senior professional colleagues & thereby find a footing for themselves in hard working, yet a lot competitive dental world. We wish to promote research & developmental activities in the world of Dentistry manifold. We also intend to increase the scientific contribution & promote development of Dentistry in Punjab especially Ludhiana. through increased exchange of knowledge & ideas. L.E.D. Journal will strive to be a high quality medium which aims to increase the understanding of new upcoming dental technologies & revolutions every month, thus with the overall goal of improving dentistry standards in Punjab especially Ludhiana.


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Insight into L.E.D. E–Journal Dear Fellow IDA Members,

Here is an insight into the basic format for the L.E.D. E–Journal: 1. The E–Journal is in a safe, secure & encrypted PDF format & all

the E–Journal download website links (from IDA Ludhiana and the

Editor-in-Chief) are compatible with all the digital devices viz.

Desktop, Laptop, Tablets, All Cell Phones (with internet) & i-Phones

as well. The encrypted format is to ensure against plagiarism.

2. The E–Journal content has been watermarked and guarded against

printing so as the authors can feel safe whilst publishing with us.

However, Authors can request the Editor-in-Chief for a printable

copy for their record, inspection or any other purposes.

3. The print version of the E–Journal would be available on request

and payment (even for authors).

4. The size lay out of the E–Journal is around 11" by 20" (A normal

A4 paper is 8" by 11") with body text size 20 and font Bookman Old

Style with 1.5 line spacing in the text. The body text is justified.

For headings, the body text size is 22 (in Red/Orange Colour).

5. The colour of the body text in the E–Journal is Plum & for

headings, images, bullets and numbering, it is Red/Orange/Pink.

For headings & images, body text with ‘Bold’ has been used.

6. The E–Journal will be available on the IDA Ludhiana Websites &

Mirror Links and also on the Editor-in-Chief’s personal website

(www.drbhavdeep.com) and across all the member emails (if

provided and on request). So, if you still haven't updated your

email id with Hon. Secretary/Hon. Treasurer, please do so at the

earliest.

7. It will be a monthly outing and would release around the first week

of every month.

8. Each issue will have around 11 articles - 8 by the crème de la

crème (best of the best) of the dentistry (National Authors from

India) which includes some of the top notch speakers and 3 from

the members of IDA Ludhiana Branch.

9. There will be some special issues in the calendar year (approx. 2-

3), in which the volume of scientific content would be huge & rich.

10. A few of the best known names are writing a series of articles as

well for the E-Journal.

11. The E-Journal will be available standalone as well as

coupled/combined with the E–Newsletter, Page 3 OLA D.


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Editorial Board Editor-in-Chief: Dr. Bhavdeep Singh Ahuja Associate Editors:

1. Dr. Navjot Singh Khurana (Conservative Dentistry & Endodontics) 2. Dr. Harsimran Singh Sethi (Pedodontics & Preventive Dentistry)

Editorial Board:

1. Dr. A. Kumarswamy (Periodontics & Implants) 2. Dr. Adwait Aphale (Dental Photography) 3. Dr. Ajay Chhabra (Conservative Dentistry & Endodontics) 4. Dr. Ajay Kakar (Periodontics & Implants) 5. Dr. Gautam Madan (Oral Surgery & Implants) 6. Dr. Kanwal Bir Singh Kuckreja (Prosthodontics & Implants) 7. Dr. Komal Khatri Majumdar (Implant Dentistry) 8. Dr. Lanka Mahesh (Implant Dentistry) 9. Dr. Navdeep Saini (Conservative Dentistry & Endodontics)

10. Dr. Neeru Singh (Pedodontics & Preventive Dentistry) 11. Dr. Rajan Jairath (Orthodontics) 12. Dr. Sameer Kaura (Oral Surgery & Implants) 13. Dr. Sanghmittra Dasgupta (Oral Surgery & Implants) 14. Dr. Sumeet Rajpal (Pedodontics & Preventive Dentistry) 15. Dr. Surinder Pal Singh Sodhi (Oral Surgery & Implants) 16. Dr. Vijay Deshmukh (Oral & Maxillofacial Surgery) 17. Dr. Vivek Saggar (Pedodontics & Preventive Dentistry)

Advisory Board:

1. Principal, Christian Dental College, Dr. Abi M. Thomas 2. Principal, Baba Jaswant Singh Dental College, Dr.

D.S.Kalsi 3. Principal, Sardar Kartar Singh Sarabha Dental College, Dr.

Rajesh Bhanot 4. President, IDA Ludhiana Branch, Dr. Tarun Kumar 5. Hon. Secretary, IDA Ludhiana Branch, Dr. Rajan Bir Singh

Thind 6. Hon. Treasurer, IDA Ludhiana Branch, Dr. Abhijit Kathpal 7. Immediate Past President, IDA Ludhiana Branch, Dr.

Jaidev Singh Dhillon 8. President-Elect, IDA Ludhiana Branch, Dr. Vandana

Chhabra 9. Dental Council Member from Punjab, Dr. Vikas Jindal

10. President, IDA Punjab State Branch, Dr. Pankaj Shiv 11. Hon. Secretary, IDA Punjab State Branch, Dr. Sachin Dev

Mehta 12. Dr. Puneet Girdhar - Past President, IDA Punjab State, &

Past Vice President IDA Head Office


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Editorial & Advisory Board, L.E.D. E-Journal – The Selected 32 Gems & Pearls

Editor-in-Chief, L.E.D. Associate Editor 1, L.E.D. Associate Editor 2, L.E.D. Dr. A. Kumarswamy

Dr. Bhavdeep Singh Ahuja Dr. Navjot Singh Khurana Dr. Harsimran Singh Sethi Periodontics & Implants [email protected]

98761 93039 Conservative Dentistry &

Endodontics Pedodontics & Preventive

Dentistry Editorial Board

Dr. Adwait Aphale Dr. Ajay Chhabra Dr. Ajay Kakar Dr. Gautam Madan

Dental Photography Conservative Dentistry & Endodontics

Periodontics & Implants Oral Surgery & Implants

Editorial Board Editorial Board Editorial Board Editorial Board

Dr. Kanwal Bir Singh Kuckreja Dr. Komal Majumdar Dr. Lanka Mahesh Dr. Navdeep Saini Prosthodontics & Implants Implant Dentistry Implant Dentistry Conservative Dentistry &

Endodontics Editorial Board Editorial Board Editorial Board Editorial Board

Dr. Neeru Singh Dr. Rajan Jairath Dr. Sameer Kaura Dr. Sanghmitra Dasgupta

Pedodontics & Preventive Dentistry

Orthodontics Oral Surgery & Implants Oral Surgery & Implants


Dr. Sumeet Rajpal Dr. Surinder Pal Singh Sodhi Dr. Vijay Deshmukh Dr. Vivek Saggar


Oral Surgery & Implants Oral & Maxillofacial Surgery



Dr. Abi Mathai Thomas Dr. Devinder Singh Kalsi Dr. Rajesh Bhanot Dr. Tarun Kumar

Principal, CDC Principal, BJSDCH Principal, SKSSDC President, IDA Ludhiana Advisory Board Advisory Board Advisory Board Advisory Board

Dr. Rajan Bir Singh Thind Dr. Abhijit Kathpal Dr. Jaidev Singh Dhillon Dr. Vandana Chhabra

Honorary Secretary, IDA Ludhiana Branch

Honorary Treasurer, IDA Ludhiana Branch

Immediate. Past President, IDA Ludhiana Branch

President-Elect. IDA Ludhiana Branch

Advisory Board Advisory Board Advisory Board Advisory Board

Dr. Vikas Jindal Dr. Pankaj Shiv Dr Sachin Dev Mehta Dr. Puneet Girdhar

Member, Dental Council of India (Punjab)

President, IDA Punjab State

Honorary Secretary, IDA Punjab State

Ex-Vice President, IDA HO

Advisory Board Advisory Board Advisory Board Advisory Board


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Your (the reader’s) opinion matters to us the most. For striving to

improve continuously, we solicit your earnest support in the form of

suggestions. The suggestions can be bouquets or brickbats as both

will be lapped up in equal measure by us. There might be areas

where, in trying to not put a wrong foot forward, we have treaded the

safe path/zone, however, in certain other sections; we might have

ruffled quite a few feathers. We do request you to just put in a few

lines to the Editor-in-Chief, Dr. Bhavdeep Singh Ahuja’s email at

[email protected] regarding what is your opinion about:

1. The design

2. The layout

3. The content and

4. other sections of the E–Journal L.E.D. (Let’s Enjoy Dentistry)

The suggestions/feedback by the members would be published with

due credits in the next issue of the E–Journal L.E.D. (Let’s Enjoy

Dentistry). However, if the Branch Member wishes to keep his/her

identity secret/hidden, the same would be given respect and the

feedback published under the heading Anonymous. Please get going,

pick up your finger and type out your feedback/suggestions and

send to the Editor-in-Chief, Dr. Bhavdeep Singh Ahuja’s email at

[email protected].


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From the EDITOR’s Desk

Dr. Bhavdeep Singh Ahuja is a Dentist in Ludhiana, Punjab, having graduated in 1998 from Punjabi University, Patiala. He has specialized in Implants from BioHorizons Inc. USA in 2004-05 & in an Advanced Course from LACE-ICOI, USA in 2006. Apart from Dentistry, he holds a Triple M.B.A. in Hospital Management, Human Resource Management & Marketing from three premier Institutes /Universities of India viz. the IIMM Pune, IGNOU New Delhi & Annamalai University. He holds Post Graduate Diploma’s in various specialties viz. Medical Law & Ethics (NLSIU), Clinical Research, Cyber Law, Disaster Management, Financial Management, Bioinformatics amongst many more from different Universities. He is a Certified Health Care Waste Manager from IGNOU & is qualified in Consumer Law as well. He is an academically oriented dentist & has many Original Scientific Publications to his credit in many International & National journals. Presently, he is into 17th year of Clinical Practice in Ludhiana, Punjab & is reachable on www.drbhavdeep.com

Dear Peers in Profession, Colleagues & My Dear Friends,

Warm Greetings from the Editor

You must have read the Part I of this Editorial in L.E.D.

October 2016, Vol. 1 Issue 10

The below is the concluding Part II of the same Editorial

Part II of II

Are Corporate Hospitals becoming the real Villain of the

society?

Asking about the rising corporate hospital sector is a question

that needs no answer. It is not just rising, but is now firmly

established. Government health services have been weakened due

to government indifference and that is why there is scope for

corporate hospitals to prosper. Due to the entry of corporate

hospitals, the order of priorities has changed. As most of the

patients believe, the doctors’ priority is no longer the best

interests of the patients, but the profit earned by the

shareholders of the company.

People’s sensitivities have also become numbed due to certain

corporate hospitals. Once bills in these hospitals start mounting

up to Rs. 10-20 lakh, people began to consider the bills of Rs.

40,000-50,000 as trivial. These hospitals have become more like

malls.

Does our society really need them?

Isn’t the provision of all tertiary health care should be provided by

the Government like the Western World?


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When we try to imitate everything else from the West from clothes

to eatables to ‘live-in’ relationships, why not the healthcare

concept as well?

Public relations officers of many corporate hospitals keep roaming

around to visit doctors; they entice doctors to send patients (to

their hospitals) by tempting them with cuts. Sad to say sooner or

later, most fall prey to such cuts (practices).

Is it Legal?

What about Hippocratic Oath?

Loud call, but won’t it be right to suggest that there is no

humanism to be found in corporate hospitals. Some believe that

small hospitals are being destroyed due to these corporate

hospitals. Going by the patients’ belief; in small hospitals, there is

at least the possibility that the doctor has not lost his basic sense

of humanism as they wait for the patient to make the payment

and give concessions and none of that happens in corporate

hospitals.

Partly true, I believe!!!!

As one of my patients told me, corporate hospitals do maintain

everything five-star style, but forget about the patient. When the

patient comes, they give him lemonade or tea advertising that

they have the latest hi-tech gadgets viz. the optics or for e.g. the

pair of specs. The patient melts because of the free lemonade and

he buys a pair of spectacles that have an actual value of Rs. 200

or so, for Rs. 3000–5000 in the name of high-tech gadgets. He

further told me that the in-house sales shop (medicine or optics)

is the main income avenue of corporate hospitals, by sometimes

offering a free check-up with a 20% off offer, just like in a mall

and the whole corporate atmosphere is just designed to tempt.

Corporate hospitals easily implement government schemes and

insurance schemes as small private clinics and hospitals

sometimes can’t afford those as the government reimbursements

are delayed, and they usually don’t have the time to keep making

trips back and forth to get their payment from the insurance

company.

Corporate hospitals vie for tie-ups with large public sector

companies and the officials are more than eager to oblige as these


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public enterprises give exorbitant reimbursement to their

employees; Rs. 5000 for a normal PFM Crown, Rs. 2000 for a

restoration (filling), Rs. 5000 for just a pair of spectacles, of

course made available from corporate hospitals. The big corporate

hospitals in Mumbai draw in cases from all over Maharashtra.

But junior trainee doctors operate on those cases! Further, often

the quality of these corporate hospitals is not as good as they

claim in their advertisements.

Just recently, the Congress MP of Rajya Sabha, Mr. M.A. Khan

made a complaint to CM of Telangana State and Medical Council

of India that the private hospitals have nothing like humanity. He

charged that corporate hospitals have changed the noble

profession of health into business. He said that his wife had fever

and dysentery and he took her to Yashoda Hospital, Malakpet. He

had already contacted the doctor of the Parliament. The

management of Yashoda Hospital asked him to deposit Rs. 25000

in advance. When he showed his CGHS Health Card, they did not

accept it. Despite this, she was admitted after paying Rs. 15000

as advance. He had already told the doctor that she had only

fever and dysentery and all the pathological tests have already

been done 8 days back and everything is normal. However,

doctors unnecessarily got her HIV, Brain, Kidney and other tests.

When his wife refused to get these tests done, she was threatened

danger to her life. The second day, when he went to hospital, he

was surprised to get a bill of Rs. 25000.

You all can see if this is the attitude of the management of a

corporate hospital with an MP, we can understand how the poor

people are treated in these hospitals. He has made a complaint

with the technical committee of Medical Council of India and

raised objections in Rajya Sabha against the looting of corporate

hospitals.

Nowadays people want glamour and marketing. They have

become used to the mall culture. The concept of ‘master check-

up’ (packages of large number of tests, of which many may be

unnecessary) has gotten into their heads and Doctors who

practice ethically and scientifically are now looked upon with

contempt, because they obviously can’t afford this glitter. But


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people often don’t know what they are getting into by going to

corporate hospitals.

The book “Dissenting Diagnosis” also quotes a general

practitioner: “Corporate hospitals often engage in marketing in a

variety of ways like ‘Buy one, get one free’, ‘Discount week’, full-

page advertisements, mostly full of falsehood promises. They

throw parties for general practitioners, and they give them cuts.

On top of this, they throw parties and supply liquor to keep

politicians in their thrall. Some corporate and large hospitals

admit bogus patients under the Rajiv Gandhi Health Scheme (a

publicly funded health insurance scheme). They give the admitted

person money and plenty to eat and drink. They prepare records

showing that an angioplasty or angiography has been done on

that person, when actually nothing has been done”.

The fault here in lies with the governments first who should first

regulate private hospitals as without it, the basic objectives of

such schemes are lost and they become mechanisms for

corporate hospitals to loot public funds.

Failure of regulation is a common notion and is no longer a

guarded secret.

The regulator of medical profession, the Medical Council of India,

itself stood discredited after the CBI arrested its former president,

Ketan Desai, on April 22, 2010, in a Rs. 2 crore bribery case. The

bribe was paid for securing permission to enroll students in a

Patiala college.

How could the regulator of Dental profession, the Dental Council

of India, be left far behind? The Ex-DCI President, Dr. Anil Kohli

was accused by the CBI of allegedly amassing huge wealth

disproportionate to his known sources of income in September

2011. The CBI was probing Dr. Kohli's role as DCI chairman

between 2006 and 2010 following allegations that he received

favours from dental colleges for verification and cancellation of

certain institutes. He had resigned from the DCI post in 2010.

After registering the case against Dr. Kohli, the CBI had carried

out searches at six places and found that Dr. Kohli had allegedly

made huge investments in properties, including a palatial house

at Gulmohar Park, four shops at Lajpat Nagar and a farmhouse


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at Chhawla (near Najafgarh). CBI also claimed to have recovered

Rs. One crore in cash during the searches at his places, besides

documents showing that he had purchased a house worth Rs. 82

lakh in Lajpat Nagar.

Now there is a move to scrap both the MCI and DCI and replace it

with a commission to regulate medical and dental education and

practices.

Hospital wrongdoings rarely surface since doctors who are aware

of these choose to keep quiet. Even those who are above board

become a party to a wrong if they maintain silence. Like other

corporate czars, hospital bosses cultivate politicians and

whosoever matters. Political patronage has helped hospital

business flourish in North India. For a clean-up job and putting

the fear of law in corporate heads, it requires a herculean effort.

Recently, the Delhi CM, Mr. Arvind Kejriwal slapped a fine of Rs.

600 crore on five Delhi hospitals, which had got land on

concessional rates but did not treat the poor as required under

the deal.

Chennai has recently seen a rise as a medical capital of India;

more than two lakh cataract surgeries in a year, a two-fold jump

in caesarean section, a sharp spiral in hysterectomies. They also

belie an uncomfortable truth: Doctors are increasingly becoming

scalpel-happy. Wide-ranging interviews with surgeons who

testified before an NGO on corrupt practices in corporate

hospitals revealed that often patients are forced to undergo

unnecessary surgeries.

A senior orthopedic surgeon in a corporate hospital explained the

reason behind this unsettling trend: "We have a quota to meet

every month. Many of us see patients as a potential candidate on

our operating table. Only two out of five, however, agree. Many go

for a second opinion and don't return. Many of these surgeries

don't involve too many risks, while at the same time fetches more

revenue for the hospitals".

A doctor on condition of anonymity said in an interview that he

was pulled up by the hospital administration for having only a

10% 'conversion rate' referring to the number of patients who

were advised to undergo surgery. To be fair, the doctors are not


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entirely at fault. For a Rs. 2 lakh surgery, the doctor, probably

gets Rs. 25,000, while the rest goes to the hospital.

Our country has very few guidelines to check the

ethical practices. Any system that rewards a doctor for the

number procedures he does is liable to abuse. Patients as they

say are becoming smarter like the smartphones and not every one

of them is falling prey to the corporate hospital ‘modus operandi’

as many go for a second opinion. Many patients have had

harrowing experiences and sleepless nights when for their

shoulder pain, a cardiac surgery was prescribed and how they got

better just with exercise and also for some, physiotherapy cured

their back pain for which a surgery was recommended.

Doctors can’t be blamed every time though as not all elective

procedures are unnecessary and sometimes early surgery is

recommended as a precautionary measure for the elderly as they

have a lot of other conditions like diabetes and hypertension that

could aggravate their problem later. In some cases, the patients'

themselves ask for a surgery like in the case of many cesarean

sections.

Corruption has many names and one of the civil society isn't

innocent either. Professionals and businessmen of various sorts

indulge in unscrupulous practices, and so do the doctors. The

allegedly unfair ‘trade’ practices by doctors/dentists enlisted

below are all flashed in the print media or the internet by various

sources, however, some of them I found pretty unrealistic:

1. 40-60% kickbacks for lab tests.

2. 30-40% for referring to consultants, specialists & surgeons.

3. 30-40% of total hospital charges.

4. Sink tests – Some tests prescribed by doctors are not needed.

They are there to inflate bills and commissions as the

pathology lab understands what is unnecessary, that’s why

these are called "sink tests" and blood, urine, stool samples

collected will be thrown ‘in the sink’.


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5. Admitting the patient to "keep him under observation" as

some people go to cardiologists feeling unwell and anxious

and most of them aren't really having a heart attack and

cardiologists and family doctors are well aware of this. They

admit such safe patients, put them on a saline drip with mild

sedation, send them home after 3-4 days after charging them

a fat amount for ICU, bed charges, visiting doctors’ fees etc.

6. ICU minus intensive care - Nursing homes all over the

suburbs are run by doctor couples or as one-man-shows. In

such places, nurses and ward boys are 10th class drop-outs in

ill-fitting uniforms and bare feet. These "nurses" sit at the

reception counter, give injections and saline drips, perform

ECG’s, apply dressings and change bandages, and assist in

the operation theatre. At night, they even sit outside the

Intensive Care Units as there is no resident doctor. In case of

a crisis, the doctor who usually lives in the same building will

turn up after 20 minutes after a call from the nurse. Such

ICUs admit safe patients to fill up beds. Genuine patients who

require emergency care are sent elsewhere to hospitals having

a Resident Medical Officer (RMO) round-the-clock.

7. Unnecessary caesarean surgeries and hysterectomies - Many

surgical procedures are done to keep the cash register ringing.

Caesarean deliveries and hysterectomy (removal of uterus) are

high on the list. While the woman with labour pains is

screaming and panicking, the obstetrician who gently

suggests that caesarean is best seems like an angel sent by

God! Menopausal women experience bodily changes that

make them nervous and gullible. They can be frightened by

words like "hemorrhoids and fibroids" that are in almost every

normal woman's radiology reports. When a gynaecologist

gently suggests womb removal "as a precaution", most women

and their husbands agree without a second thought.

8. Cosmetic surgery advertised through newspapers like

Liposuction and plastic surgery are not minor procedures.


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Some are life-threateningly major, but advertisements make

them appear as easy as a facial and waxing.

9. Indirect kickbacks from doctors to prestigious hospitals – To

be on the panel of a prestigious hospital, there is give-and-

take involved. The hospital expects the doctor to refer many

patients for hospital admission. If he fails to send a certain

number of patients, he is quietly dumped and so he likes to

admit patients even when there is no need.

10. "Emergency surgery" on a dead body – If a surgeon hurriedly

wheels your patient from the Intensive Care Unit to the

operation theater, refuses to let you go inside and see him,

and wants your signature on the consent form for "an

emergency operation to save his life", it is likely that your

patient is already dead. The "emergency operation" is for

inflating the bill; if you agree for it, the surgeon will come out

15 minutes later and report that your patient died on the

operation table and then, when you take delivery of the dead

body, you will pay OT charges, anesthesiologist's charges,

blah-blah-

I was myself shocked when I heard a few of these on National

Television News (‘Aaj ka Sabse Bada Khulaasa’) or read on the

Internet about these above.

I just wondered how widespread this is or, is it a matter of a

few black sheep giving a bad name to the entire fraternity? The

media have also segregated the same into 2 categories:

1. Young surgeons and old ones: The young ones who are setting

up nursing home etc. have heavy loans to settle. To pay back

the loan, they have to perform as many operations as possible.

Also, to build a reputation, they have to perform a large

number of operations and develop their skills. So, at first,

every case seems fit for cutting. But with age, experience and

prosperity, many surgeons lose their taste for cutting, and stop

recommending operations.


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2. Physicians and surgeons: To a man with a hammer, every

problem looks like a nail. Surgeons like to solve medical

problems by cutting, just as physicians first seek solutions

with drugs. So, if you take your medical problem to a surgeon

first, the chances are that you will unnecessarily end up on the

operation table.

It’s up to our inner conscience that we don’t resort to any of the

above. Doctors too are humans and mistakes happen. But when

payment before treatment is the rule and relations become

commercial, as in corporate hospitals, then forgiving a blunder

becomes difficult.

So, have you guys ever wondered, why is this greed culture

setting in?

Thoughts generate desires and then thinking about the

methods to fulfill them, we tread the wrong path. The energy

called ‘desire’ has been condemned for centuries. Almost all the

so-called saints have been against it, because desire is the very

source of all that you see and they were against all that which is

visible. They wanted to sacrifice the visible at the feet of the

invisible; they wanted to cut the roots of desire so there would no

longer be any possibility of life. Firstly, desire itself is God. Desire

without any object, desire without being goal-oriented,

unmotivated desire, pure desire, is God.

Your very being is desire; to be against it is to be against

yourself and against all. Desire is creativity. God created the

world because a great desire arose in him — a desire to create, a

desire to manifest, a desire to make many from one, a desire to

expand. Desire means a longing, a great longing, to expand, to

become huge, and to be enormous as huge as the sky. In fact,

what the man who wants to have more and more money really

wants is not money but expansion, because money can help you

expand. The man who is after money may not know why he is

after the money. He may himself think and believe that he loves

money, but that is only on the surface of his consciousness. Men

want more power, more fame, longer life, better health, but what

do they desire in these different things? They don’t want to


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remain confined; they don’t want to be limited. It hurts that you

have limitations, because to have limitations means to be

imprisoned. But all these objects of desire, sooner or later,

disappoint. Money has brought a few blessings, but in the same

measure it has brought many curses too. You can have a bigger

house, but now you will have less peace. You can have a bigger

bank balance, but you will also have a bigger madness, anxiety,

neurosis, psychosis. Money has brought a few things which are

good; in the wake of it many other things have arrived which are

not good at all. And if you look at the whole thing, the whole effort

has been a sheer wastage and now you cannot have even the

‘hope’ that the poor man can have. The rich man becomes

hopeless as he has tasted all kinds of things; now he only feels

tastelessness. A kind of death has already happened, because he

cannot conceive of how to fulfill that desire for expansion. But

desire in itself is not wrong. The desire for money, the desire for

power and the desire for prestige are all wrong objects for desire.

You can have a sword and you can kill somebody; that does not

make the sword wrong as you can also save somebody with the

same sword. Poison can kill and poison can become medicine too.

In the right hands, poison is nectar; in the wrong hands, nectar is

poison. This is the essential

wisdom of all the ‘Buddhas’ of all the ages. Intelligence means the

insight that no object can fulfill your desire. The intelligent person

stops desiring objects. He makes his desire pure of all objects

worldly, other worldly. He starts living his desire in its purity,

moment to moment. Desire is beautiful, as there is nothing wrong

in it; just free it from objects. With freedom from objects, desire is

divine and pure; close to GOD.

What do you think about the desires of mankind?

Thank You, See you ALL in the FINALE issue!!!!!

Yours truly,

Bhavdeep

The above is the Second part of two (II) parts of the Editorial.

For reading Part I of this Editorial, check out L.E.D. October

2016, Vol. 1 Issue 10


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Dr. Edwin Roberto Hernandez Molina graduated in 1995 from University of El Salvador, Central America. He started his private practice from 1997 and after that; he attended to Real World Endo course at Baylor College, Dallas TX in 2004. He has taken Implant courses from Brasseler and Zimmer in 2008 and 2009. He started studies and National University of Colombia, Bogotá branch in 2011 and graduated from a 2 years full time specialty program in Endodontics in 2013. He practiced for 3 years in Bogotá, Colombia. He has been a lecturer in El Salvador and also has been a teacher at national universities for pre-graduate students & for 3 years as a Co-Coordinator of diplomat studies in endodontics for Universidad Evangelica from El Salvador. He has a private practice limited to Endodontics and is presently working as an Endodontist in the Central Military Hospital of El Salvador, Central America.

CBCT in ENDODONTICS A Boon for Effective Treatment & Cure

Author: Dr. Edwin Roberto Hernandez Molina

ABSTRACT

The Radiography is an essential tool to correct diagnosis and

endodontic management related to odontogenic and non-

odontogenic pathologies, treatment planning, intra operative

assessment, recording and appraisement of the endodontic

procedure end result and outcome. Until recently most of the

imaging information in endodontics was obtained through film

based or digital radiographs, these provided useful information:

as the presence and location of peri-radicular lesions, root and

root canal anatomy, proximity with adjacent anatomical

structures. But these types of images have inherent limitations.

The main limitation is, that conventional or digital radiographs

comprise a two dimensional image of a tri-dimensional object,

with an effect on diagnostic capacity. The important features of a

tooth and surrounding hard tissues are viewed only in a proximal

plane (mesio - distal), and can not be valued in a buccal-lingual

plane.

The spatial relation of the dental root with its surrounding

anatomical structures and associated peri-radicular lesions can

not always be assessed with conventional radiographs. As an

alternative to some disadvantages from conventional radiography,

exposures with 10º-15º horizontal angles shifts can be made. This


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might be necessary in diagnosis of traumatic dental lesions as

radicular fractures, avulsions, luxations or judgement of internal

or external resorptions.

It is important to consider that’s not always possible to obtain

an ideal position of the dental X-ray film or digital sensor, as a

consequence could happen variations angles and increase or

reduce the root’s length of the tooth under investigation or even

hide and hinder the appearance of peri-radicular lesions.

Imaging, thus forms the most essential part of all steps in

Endodontics.

INTRODUCTION

Cone Beam Computed Tomography (CBCT) is a diagnostic

imaging modality that provides high-quality, accurate three-

dimensional (3D) representations of the hard tissues and osseous

elements of the maxillofacial skeleton. This extraoral imaging

system was created at the end of the 90’s, to produce

tridimensional scans of the maxillofacial skeleton with a

considerable less radiation dose compared to the computed

tomography.

A single scan is made, where source and sensor rotates the

patient’s head in 180º or 360º (Fig. 1).

Fig-1: CBCT Details

(Image Source: Google)


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The X-ray beam is divergent or conical where a cylindrical or

spherical volume data is captured described as the field of view

(Fig. 2 and Fig. 3).

.

Fig-2: CBCT Field of View


Fig-3: CBCT Slices and Image acquisition



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Fig-4: Image Display in 3 Orthogonal Planes


Images are displayed simultaneously in three orthogonal planes:

Transverse, Sagittal and Coronal (Fig. 4).

Cone Beam Computed Tomography with a limited Field of View

(FOV) may be considered in the following situations:

1. Diagnosis of radiographic signs of periapical pathosis when

there are contradictory (nonspecific) signs and/or symptoms;

2. Confirmation of nonodontogenic causes of pathosis;

3. Assessment and/or management of complex dento-alveolar

trauma, such as severe luxation injuries, suspected fracture of

the overlying alveolar complex and horizontal root fractures,

which may not be readily evaluated with conventional

radiographic views;

4. Appreciation of extremely complex root canal systems prior to

endodontic management (for example, class III & IV dens

invaginatus);

5. Assessment of extremely complex root canal anatomy in teeth

treatment planned for non-surgical endodontic re-treatment;

6. Assessment of endodontic treatment complications (for

examples, [post] perforations) for treatment planning purposes

when existing conventional radiographic views have yielded

insufficient information;

7. Assessment and/or management of root resorption, which

clinically appears to be potentially amenable to treatment;


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8. Pre-surgical assessment prior to complex peri-radicular surgery

(for example posterior teeth).

Clinicians must have core knowledge of CBCT radiography before

requesting CBCT scans and must regularly update their

knowledge. The principles of radiation protection must also be

adhered to. A CBCT scan should have a net benefit to the

management of a patient’s (suspected) endodontic problem. A

comprehensive discussion must take place between the clinician

and patient; only then is the patient’s consent to undergo a CBCT

procedure valid.

As with any ionizing radiation imaging device, the radiation dose

must be kept ‘as low as reasonably achievable’. Indeed, when

considering whether to use CBCT, there is a much greater

responsibility on clinicians to justify its use due to the increased

ionizing radiation.

The entire volume of data must be assessed and reported on. This

would normally be completed by the clinician who has prescribed

the scan, or the practitioner who has taken the scan; however, it

is essential to refer the CBCT image data to a competent person if

the interpretation of the scan is beyond the competence of the

clinician who has prescribed it.

Successful management of endodontic problems is

reliant on diagnostic imaging techniques to provide critical

information about the teeth under investigation, and their

surrounding anatomy. Since its inception, conventional

radiography has remained the mainstay of imaging in

Endodontics.

Cone beam computed tomography reconstructed scans are

invaluable for assessing teeth with unusual anatomy, such as

teeth with an unusual number of roots, dilacerated teeth and

dens in dente. The exact location and anatomy of the root canal

system can be assessed, allowing successful management of the

case.

Previously, even with the aid of magnification, the anatomy of

such a tooth may not be truly appreciated, making treatment

more unpredictable. CBCT systems are available that now provide


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small field of view images at low dose with sufficient spatial

resolution for applications in endodontic diagnosis, treatment

guidance and post treatment evaluation.

This case report provides a perfect example of CBCT as

an imaging adjunct for Endodontics and proves that CBCT has

become a gold standard in diagnosis and treatment planning in

Endodontics now.

CASE REPORT

HISTORY

A female patient 70 years of age referred to our Military Dental

hospital for root canal treatment of the upper right first molar

right.

DIAGNOSIS

Symptomatic Irreversible Pulpitis

RADIOGRAPHIC EXAMINATION

The preoperative radiographic image showed us only two roots

(upper right first molar) instead of the usual three.

Fig-5: Pre-Operative Radiographic View of 16


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TREATMENT PROTOCOL

1. In the preoperative radiographic image, it was suspected to

have a presence of only 2 roots (Fig. 5 & Fig. 6) and with this

finding in mind; we proceeded to make the endodontic access.

2. During the procedure and clinical observations of upper right

first molar (16) and due to the high frequency of finding 3

roots in maxillary first molars in percentages above 90%

occurrence, we stopped our non-surgical endodontic

procedure and asked the patient to go for a CBCT study to

confirm the number of roots and canals, so as to avoid the

risk of iatrogenic perforation.

Fig-6: Pre-Operative Radiographic View of 16


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3. In 2015, the American Association of Endodontists (AAE) and

the American Academy of Oral and Maxillofacial Radiology

(AAOMR) made an update to the position statement on the

use of computed tomography cone beam (CBCT) to provide

clinicians a science-based guide the use of CBCT in

endodontic treatment.

Fig-7: Working length X-ray of 16

4. As has been demonstrated radiographic images (intraoral and

panoramic) only provide two-dimensional representations of

three-dimensional anatomical structures, but the complex


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anatomies and surrounding structures can hinder the

interpretation of planar images.

Fig-8: Access Opened with 16

Fig-9: Clinical View of Prepared canals with 16

5. Knowing that there may be anatomical variations between

different types of teeth and in this case that concerns us, the

two-dimensional X-ray did not meet the requirements;

therefore an intra-operative CBCT study for the identification

and location of the root canal system in the first upper right

molar was recommended.


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6. Finally, in CBCT images from the study in TRIDENTAL, the

presence of 2 root and 2 lines in the first upper right molar

was confirmed (Fig. 10, Fig. 11, Fig. 12, Fig. 13, Fig. 14, Fig.

15, Fig. 16 and Fig. 17).

Fig-10: 3D Representation with 16

Fig-11: 3D Model reconstructed

Fig-12: Multiplanar of Buccal Canal is marked with Purple arrow and remnants of obturation with Yellow arrow


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Fig-13: Another View of above

Fig-14: Occlusal View of Buccal Canal

Fig-15: Multiplanar of Palatal Canal is marked with Purple

arrow and remnants of obturation with Yellow arrow


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Fig-16: Another View of above

Fig-17: Occlusal View of Palatal Canal

7. We then proceeded with the normal Endodontic treatment,

Obturation & Restoration. The description of the performed

endodontic procedure is as below:

a. Endodontic access was made with carbide burs and

additional cavity refinement was done with the aid of

cylindrical and conical diamond burs.


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b. Search of root canals over the pulp floor with endodontic

explorer and further refinement with CAP2 and CAP

ultrasonic tips from Acteon Satelec.

c. Palatal canal prepared up to Revo S, AS40 file.

d. The buccal canal found and prepared up to Revo S, AS35

file (thought was the DB canal).

e. Search for Canal MB1 canal was made.

f. Irrigation with 5% sodium hypochlorite and active

ultrasonic irrigations with Irrisafe tip (Acteon Satelec).

g. Intracanal medication with calcium hydroxide based paste

(Metapaste, Meta Biomed), CBCT scan indicated.

Fig-18: Completed Obturation with 16


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8. Second visit: Details

a. Irrigation with 5% sodium hypochlorite and active

ultrasonic irrigation.

b. Obturation of palatal canal with a size #45 ISO master

cone and buccal canal #40 taper 0.04 master cone.

c. Warm vertical compaction of Gutta-percha.

d. Backfill with E&Q Master (Meta Biomed), resin based

sealer (AdSeal, Meta Biomed).

e. Finally a 3D Obturation was achieved (Fig. 18 and Fig.

19).

f. Sent back to the referral colleague for final restoration.

Fig-19: 3D Obturation with 16


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REVIEW of LITERATURE

B. Cleghorn, W. Christie and C. Dong in 2006 (Root and Root

morphology of the human maxillary molar first permanent

channel: A literature review, JOE, Volume 32, Number 9

September 2006) did a literature review of the anatomy root and

ductwork permanent maxillary first molar; for which four

anatomical studies were taken into account, where indicated that

the maxillary molar NORMALLY has 3 roots in 96.2% of cases

(416 teeth). The presence two roots was found in 16 (3.8%) of the

teeth studied (Fig. 20). Variations may be a result of ethnicity, age

and gender of the population studied.

Fig-20: Review of Literature

CONCLUSION

In conclusion, the success of non-surgical endodontic

treatment depends on the accurate identification of root

canals, cleaning, shaping and obturation of root canal

systems and the quality of the final restoration. 2-D images

result reveals not the actual number of roots and root

canals. In studies, the data acquired by CBCT have shown

a strong correlation between reconstructions and sectioning

through the CBCT and histological examination (J Michetti,

Maret D, JP Mallet, F. Diemer Validation of cone beam

computed tomography as a tool to explore root canal

anatomy Endod J 2010; 36 (7):. 1187-1190).


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SUMMARY

Radiography is an integral part of dental diagnosis and most

commonly used radiograph is IOPA X-ray. IOPA though has

varied implications in dentistry but the biggest drawback is

that it gives only a 2-dimensional aspect of the area in

question. Cone Beam Computed Tomography or the C-arm CT

or Cone Beam Volume CT or CBCT is a medical imaging

technique which gives an accurate idea of canal anatomy and

anatomical landmarks can be marked out as well so that

clinician is able to make his own judgment. CBCT’s scope in

Endodontics is beginning to gain much popularity now such

as to study the accessory canals in a teeth or to see vertical

root fractures in teeth. CBCT is also used effectively for pre-

surgical assessment of position of root apices with respect to

structures like Inferior Alveolar Nerve/Canal (IAN) and

maxillary sinus being most accurate. CBCT plays an

important role in planning for periapical microsurgery on the

palatal roots of maxillary first molars. The distance between

the cortical plate and the palatal root apex can be measured,

and the presence or absence of the maxillary sinus between

the roots could be assessed. CBCT is an excellent tool to see

variations in root canal anatomy and to check the exact

positioning of the apical foramen. CBCT is also helpful in

providing valuable information for determination of type and

severity of dental trauma, horizontal root fractures, alveolar

fractures and other radiolucencies which are otherwise

difficult to find in a normal X-ray. CBCT is of extreme help in

torturous root canal anatomy cases or repeated failure of root

canal treatment. The reason why CBCT is getting popular in

dentistry over the regular CT is very low radiation exposure in

CBCT when compared to a regular CT Scan. Successful

management of endodontic problems is reliant on diagnostic

imaging techniques to provide critical information about the

teeth under investigation, and their surrounding anatomy and


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CBCT is fast becoming the mainstay of imaging in

Endodontics.

REFERENCES

1. B. Cleghorn, W. Christie and C. Dong in 2006 (Root and Root

morphology of the human maxillary molar first permanent

channel: A literature review, JOE, Volume 32, Number 9

September 2006)

2. J Michetti, Maret D, JP Mallet, F. Diemer Validation of cone

beam computed tomography as a tool to explore root canal

anatomy Endod J 2010; 36 (7):. 1187-1190).

3. S. Patel, C. Durack, F. Abella, M. Roig, H. Shemesh, P.

Lambrechts, K. Lemberg. European Society of endodontology

position statement: The use of CBCT in endodontics.

International endodontic journal 47, 502-504, 2014.

P.S. Any feedback/compliments/queries for the Author/s should

be emailed to the Editor-in-Chief, Dr. Bhavdeep Singh Ahuja at

his email id: [email protected]


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Pehla Gyaan


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Dr.S.P.S.Sodhi is the Principal, DIRDS, Faridkot. He passed both his BDS (1983) & MDS in Oral Surgery (1988) from GDC Amritsar. He is practicing Oral Surgery actively since 25 years & Dental Implants since 17 years. He has been a Keynote speaker at various International & National Conferences in India & abroad. He is a recognized Inspector of the Dental Council of India & is also the Editor of Baba Farid University Dental Journal. He has been very active in IDA as well & has held key positions in the past at Local & State Level as well. Dr. Gursimrat Kaur Brar did both her Graduation (BDS – 2001) & Post Graduation (MDS in Oral Surgery – 2015) from DIRDS, Faridkot. Presently, she is working as a Senior Lecturer in Department of Oral & Maxillofacial Surgery in DIRDS, Faridkot.

Dr. Dikshit Behal passed his BDS from Gian Sagar Dental College & Hospital, Ram Nagar, Banur. Presently, he is a Post Graduate Student in the Department of Oral & Maxillofacial Surgery in DIRDS, Faridkot.

Sialolithiasis of Submandibular Gland Duct

A Rare Case Report

Author: Dr. S.P.S.Sodhi

Co-Author 1: Dr. Gursimrat Kaur Brar

Co-Author 2: Dr. Dikshit Behal

ABSTRACT

Sialolithiasis is one of the most common diseases of the salivary

glands and is characterized by the obstruction of salivary gland or

its duct due to the formation of calcareous plaque. It most

frequently occurs in the submandibular salivary gland due to its

anatomic features. The term giant sialolith is used for the stones

over 15 millimeters in any one dimension. It is rarely reported in

the literature. Although, large sialoliths have been described in

the body of salivary glands, they are rarely found in the salivary

ducts. We report a rare case of a giant sialolith of submandibular

gland duct in a 36 year old female. The sialolith was removed

surgically via intra-oral approach. No recurrence was seen on

follow-up.

KEYWORDS

Sialolith, Sialolithiasis, Submandibular gland, Submandibular

duct


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INTRODUCTION

The word ‘sialolith’ literally means calculus in a salivary gland or

duct. Sialolithiasis is defined as the formation of calcific

concretions within the parenchyma or the ductal system of a

major or minor salivary gland. Sialolithiasis is the second most

common disease of the salivary glands after mumps and is

characterized by the obstruction of a salivary gland or its

excretory duct by a calculus or sialolith associated with swelling,

pain, and infection of the affected gland, resulting in salivary

ectasia. The submandibular gland is the most common site for

sialolithiasis (80% - 90%), followed by the parotid gland (5% -

20%). The sublingual gland and minor glands are very rare sites

for sialolithiasis (1% - 2%).

The sialolith are calcium – rich crystallized minerals

typically composed of calcium phosphate or calcium carbonate in

association with other salts and organic material such as

glycoproteins, mucopolysaccharides and desquamated cellular

residue. Bacterial elements have not been identified at the core of

a sialolith.

Demographically, sialolithiasis affects 12 in 100 of the

adult population with male preponderance being twice as much

as females. All age may be affected, although patients in their

third to sixth decade represent the majority of cases, children are

very rarely affected (3%). Simultaneous sialolithiasis in more than

one salivary gland is rare, occurs in fewer than 3% of cases. Also,

70 to 80% of cases feature solitary stones; only about 5% of

patients have three or more stones. There is no left or right

predominance.

Sialoliths can lead to retrograde infection of the duct systems,

strictures, neoplasms, and local trauma are to be considered as

etiological factors. Submandibular sialolithiasis occurs as a

consequence of a hampered flow due to inflammatory stenosis of

Wharton’s duct; moreover, there are some anatomical factors

associated with formation of sialoliths in the submandibular

gland, such as: Wharton’s duct is the longest among the salivary

glands’ ducts; The path of Wharton’s duct goes in an upgoing

direction and the main portion of the duct is wider than the


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orifice; Along with these anatomical factors, the peculiar

composition of the submandibular gland saliva, that is alkaline

and rich of mucin, is relevant for the beginning of sialolith

formation. There is stasis of saliva, precipitation of salts and

organic matrix formation. Dehydration, allergic states, infection of

the oral cavity make saliva denser and start the accumulation of

ductal debris which in turn allow the precipitation of mucoid

elements and salts in order to form the organic matrix. When the

stone reaches a size to obstruct the duct the secretion in the

gland is hampered. This condition facilitates destruction of the

gland.

In this present case report, we present a case of giant sialolith in

the submandibular gland duct, which was successfully treated

via intra-oral approach. No recurrence was seen on follow-up.

CASE REPORT HISTORY & CHIEF COMPLAINT

A 36 year old female patient reported to the Department of

Oral and Maxillofacial Surgery at Dasmesh Institute of Research

and Dental Sciences, Faridkot with the chief complaint of

irritation on the under surface of tongue on right side since 15

days.

History dates back to 3 months when patient started feeling

irritation and swelling in the floor of the mouth on right side.

Patient went to a private dental practitioner, where according to

her, a small piece of stone was removed from the floor of the

mouth and medication was prescribed. Now, about 15 days prior

to this visit, she again started feeling the same irritation and

swelling in the same region and reported to our department for

the treatment of the same. There was no history of any

spontaneous discharge.

INTRA-ORAL EXAMINATION

Clinical examination revealed a yellowish irregular mass with

inflamed sublingual mucosa with respect to the right side of the

floor of the mouth, measuring 2.5cm x 1.5cm in size (Fig.1).


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Palpation of the area indicated a nodular, slightly tender mass,

which was stony hard in consistency.

Fig-1: Pre-Operative Intra-Oral View


We went in for the mandibular occlusal radiograph of the

patient which revealed a radio opaque mass w.r.t. floor of mouth

on the right side (Fig. 2). Provisional diagnosis of sialolith with

respect to right submandibular gland duct was made.

Fig-2: Pre-Operative Mandibular Occlusal Radiographic View

INVESTIGATIONS

All the routine blood investigations of the patient were within

normal range and viral markers were negative.


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TREATMENT PLAN

Surgical excision of the mass was planned under local anesthesia

under strict aseptic conditions.

TREATMENT PROTOCOL

1. Part preparation was done and patient was draped in the usual

manner.

2. Local anesthesia was achieved using 2% lignocaine with

1:80,000 adrenaline using right lingual nerve block and local

infiltration.

3. A stay suture was tied distal to the opening of submandibular

gland duct (Fig. 3).

Fig-3: A Stay Suture tied to the Opening of Submandibular Duct

Fig-4: Vertical Incision along the tract of Wharton’s duct


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4. h

grasped with Allis forceps and with the

With bi-digital manipulation and with stay suture, the sialolit

was reflected and vertical incision was given along the tract of

Wharton’s duct (Fig. 4).

5. Then the sialolith was

help of a periosteal elevator (Fig. 5), the sialolith was popped

out (Fig. 6) and primary closure was achieved using 3-0

Mersilk suture (Fig. 7).

Fig-5: Elevation of Sialolith with Periosteal Elevator

Fig-6: Popped out Sialolith


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Fig-7: Primary Closure with 3-0 Mersilk Suture

6. The extracted sialolith was then sent for histopathological

examination to confirm the diagnosis (Fig. 8) and biopsy

confirmed the clinical diagnosis.

Fig-8: Retrieved Sialolith sent for Histopathological

Examination


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7. Healing was uneventful.

8. The patient was followed up for 2 months post operatively and

there had been no recurrence.

9. Salivary flow was found to be normal and patient was relieved

of the symptoms.

DISCUSSION

Sialolithiasis is the most common non-neoplastic disease of the

salivary gland and autopsy reports show a 1.2% incidence across

the population. Sialoliths occur most frequently in adults during

the 4th, 5th and 6th decades, but can occurs at any age. Diagnosis

of sialoliths is both clinical and radiographic.

Patients generally develop symptoms when the sialolith

begins to obstruct salivary flow, leading to swelling and eventually

pain that occurs before or during meals. Sialoliths present with

painfu only

(12%), stasis of saliva can ding to retrograde flow of

a of the gland, in which the patient

ductal system of the submandibular and

sublingual ducts are located beneath the mucosa of the floor of

the mouth, a stone in the sublingual gland/duct may be

misdiagnosed as of submandibular gland/duct sialolithiasis in

clinical practice especially, when it is in large and near the gland.

The location of the stone and involved gland must be known

preoperatively, because sublingual gland sialolithiasis is usually

treated with resection of the sublingual gland with the stone via

trans-oral approach, in contrast to the submandibular gland,

which is treated with transoral sailolithotomy or excision of the

submandibular gland through an extra-oral approach.

When the stone is located within the gland, it is not difficult to

identify which gland is involved using CT, however; most stones

(75% - 85%) are located in the duct. In our case the stone was

located in the submandibular gland duct (Wharton’s duct). When

l swelling (59%), painless swelling (29%), and pain

also occur lea

bacteria into the parenchym

may present with purulence from the duct, leucocytosis and

fever.

The most prominent complaint of our patient was irritation

under the tongue, which prompted her to seek the treatment.

Since both the s


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an accompanying abscess develops, it is easier to identify which

gland is involved and where the stone is located by physical

ay require

ial diagnosis is important because of the

pation.

If the stone is too large, or located in the proximal duct,

examination because a sublingual gland abscess mainly presents

with painful swelling over the unilateral mouth flow, whereas a

submandibular gland abscess always presents with painful

swelling over the submandibular area of the neck. Our patient

complained of mild irritation with respect to ventral surface of

tongue. Sialolithiasis treatment depends on the localization of the

salivary calculus, for those closer to the ostium, duct

catheterization and dilatation facilitate and allow retrieval of the

sialolith. For those located in the anterior half of the duct,

surgical intervention is the best choice. Finally the ones located in

the posterior region of the duct or within the gland m

total gland removal.

In our patient, the stone was located in a position jutting out

of the orifice so the patient was relieved of her complaining

symptom by a simple outpatient procedure in which a small

incision was given around the orifice of the duct and the stone

popped out by simple bi-digital manipulation of the duct.

Solitary sialoliths usually do not recur; although chronic multiple

recurrence of sialolith has been reported. Lustmann et al

estimated that the recurrence rate of sialolithiasis is 8.9%. In our

patient, the follow-up was for two months post operatively and

there had been no recurrence.

CONCLUSION

Standard mandibular occlusal radiograph is one of the best

diagnostic options to determine the calculus in the

submandibular gland duct. Sialography, Ultrasonography,

Computerized Tomography and MRI may help in diagnosis.

Preoperative different

different surgical approaches. The primary objective of the

treatment of the sialolith is the restoration of the normal salivary

secretions. Different treatment options may be selected according

to the size and location of the sialolith. Small stones often may be

“milked out” through the ductal orifice using bimanual pal


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piezoelectric extracorporal shock wave lithotripsy or surgical

removal of the stone or the gland may be required.

BIBLIOGRAPHY

1. Batori M., G. Mariotta et al: Diagnostic and surgical

management of submandibular gland sialolithiasis: report of a

ual size: ERMPS: 2005; 9:67-68.

5. Eyigor H., Osma U., Yılmaz M.D., Selcuk O. T. Multiple

sialolithiasis in sublingual gland causing dysphagia, Am J

Case Rep, 2012; 13: 44-46

6. Hong KH, Yang YS: Sialolithiasis in the sublingual gland. J

LaryngolOtol, 2003; 117(11): 905–7

zoni D, de Carvalho PS et al: Sialolithiasis of the

literature. J Oral

and a

d]

]

stone of unus

2. Bodner L. Salivary gland calculi: Diagnostic imaging and

surgical management. Compendium 1993; 14:572-86.

3. Cawson RA, Odell EW. Essentials of oral pathology and oral

medicine.6th ed. pp 239-40. Ediburgh: Churchill Livingstone,

1998.

4. Choi J, Kim K, and S. Oh: Multiple sialoliths in sublingual

gland: report of a case. Int J. Oral MaxillofacSurg, 2002; 31(5):

562–63

7. Jardim EC, Pon

submandibular gand. J CraniofacSurg, 2011; 22(3): 1128–31

8. Ledesma-Montes C, Garcés-Ortìz M, Salcido-Garcìa JF, et al.

Giant sialolith: case report and review of the

MaxillofacSurg 2007; 65: 128-30.

9. Leung AK, Choi MC, Wagner GA. Multiple sialoliths

sialolith of unusual size in the submandibular duct. Oral Surg

Oral Med Oral Pathol Oral RadiolEndod 1999; 87: 331-33

[PubMe

10. Levy DM, ReMine WH, Devine KD. Salivary gland calculi. Pain,

swelling associated with eating. JAMA 1962; 181: 1115-1119

[PubMed

11. Liao L.J., Hsiao J. K., Hsu W.C., Sublingual gland sialolithiasis:

a case report Kaohsiung J Med Sci2007;23:590–3)


L.E.

D. E

-Jou

rnal

IDA

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12. Lustmann J, Regev E, Melamed Y. Sialolithiasis: A survey on

245 patients and a review of the literature. Int J Oral

of

PubMed]

MaxillofacSurg 1990; 19:135-8.

13. Marchal F, Dulguerov P. Sialolithiasis management: the state

the art. Arch Otolaryngol Head Neck Surg2003; 129:951–6.

14. McKenna JP, Bostock DJ, McMenamin PG. Sialolithiasis. Am

Fam Physician 1987; 36: 119-25. [

15. Nahalieli o, Eliav E, Hasson O, Zagury A, Baruchin AM.

Pediatric sialolithiasis. Oral Surg Oral Med Oral Pathos

OralRadiolEndod 2000; 90: 709-12.

16. Rauch S, Gorlin RJ:Diseases of the salivary glands. In: Gorlin

RJ, Goldman HM, editors. :Thoma’s Oral Pathology (6thedn), vol

2. St Louis: Mosby; 1970. p. 997-1003.

17. Stafne, E. C., and Gibilisco, .I. A.: Oral Roentgenographic

Diagnosis, ed. 4, Philadelphia, 1975, W. B. Saunders

Company,pp. 135-141.

18. Tyler T. Boynton, DMDStuart E. Lieblich, Unusual case of a

sialolith: a case report. 2014;117:1:e9–e10.

19. Williams MF.Sialolithiasis.OtolaryngolClin North Am 1999

Oct;32(5):819-34 [PubMed]

20. Yildirim A. A case of giant sialolith of the submandibular

Six years of practical

eep Singh Ahuja at


salivary gland. Ear Nose Throat J. 2004 May;83(5):360-1

[PubMed]

21. Ziegler CM, Steveling H, Seubert M et al: Endoscopy: a

minimally invasive procedure for diagnosis and treatment of

diseases of the salivary glands.

experience. Br J Oral MaxillofacSurg, 2004; 42(1): 1–7.


be emailed to the Editor-in-Chief, Dr. Bhavd


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Doosra Gyaan


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Dr. Ajay Kakar is a Periodontist from N.H.D.C. Mumbai, 1985. He is the currently, the President of International Academy of Periodontology. He is a Clinical Associate Professor in Stony Brook, SUNY-USA & a faculty in Manchester University for the Distance Education Program. He is the author of a handbook on Splinting (Management of Mobile & Migrating Teeth) published in an International Journal. He is a genius with a thorough & detailed knowledge on Computers and has written a book as well for the beginners. He is the founder director of Bite-In and is a clinician par excellence with current practice in Le-Visage Dental Clinic, Chembur, Mumbai, with practice limited to Periodontology & Implants.

Power Scaling

Boon or Bane

Part III

Author: Dr. Ajay Kakar

POWER DRIVEN SCALERS

The origins of power driven scaling has very unique origins. The

first ultrasonic scaler was intended to be an instrument for cavity

preparation, but the company had not accounted for the

resiliency of the dentinal tubules. Instead of using the instrument

for cavity preparation it worked adroitly as an instrument for the

removal of plaque and calculus.

Effective ultrasonics can be applied when electrical energy

is converted into mechanical energy with surface vibrations in

excess of 20,000 Hz, a level beyond human hearing. Calculus,

dental cementum, stains and other soft and hard deposits that

collect on teeth can be removed with this instrumentation.

Power driven scalers can be classified into three groups based on

the basic design ideology of the equipment. These are

1. Sonic Scalers

2. Magnetostrictive Scalers

3. Piezo Electric Scalers

All the above types of scalers work with slightly different

methodologies and hence have varying degrees of efficiency. A

clinician should be aware of the different characteristics of these

scalers to be able to decide and choose the most suitable

equipment.


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1. Sonic Scalers: Sonic scalers are driven by compressed air and

create vibratory energies from pressure. Sonic scaler

handpieces will generally fit onto the regular air rotor

handpieces. They generally work at frequencies ranging from

1500 to 7000 Khz depending upon the handpiece and the

pressure of the compressed air.

These scalers have a wide range of amplitude which is

upto 1.5 mm from the center and the tip generally moves in an

orbital fashion. Sonic scalers are susceptible to hand-pressure

damping, which limits the amount of energy which can be

applied to the tooth surface and this thereby lessens the

efficiency of the scaler.

Sonic scalers do not even exhibit a phenomenon

known as cavitation. On a comparison level with the other two

kinds of scalers, sonics are not as efficient in removal of

calculus. In spite of the not so great efficiency at removal of

calculus, these units are capable of removing more than 100

um of cementum during routine debridement. The average

width of the cementum is about 150 um and most of this layer

can be lost if extreme care is not taken while scaling with these

units.

The sonic instruments should be used only on supragingival

areas and never in areas of recession or exposed root surfaces.

A few of the commonly available Sonic scalers are available

from JR Rand Corp, Kavo, Kinetic Instruments, Medidenta and

Star Dental. All these scaler handpieces or at least the tips are

autoclavable. Almost all of them operate at a vibratory

frequency of 6000 Mhz. These scalers generally have upto 3

tips in different shapes for accessing various sites in the oral

cavity. These scalers have been in use now for close to 20

years.

2. Magnetostrictive Scalers: These class of scalers can easily

lay claim as the first kind of ultrasonic devices to be made for

power driven scaling. These instruments work on the principle

of conversion of electrical energy to magnetic energy to

vibratory energy. The vibration of the tips of these scalers is


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elliptical in nature which enhances the application of energy to

the tooth for debridement.

Magnetostrictive scalers have a base unit and metal

inserts of different tip shape and sizes. The base unit processes

the electrical energy and applies it to the inserts. The insert

has a stack of metal plates at the base which is inserted into

the socket of the base unit. The other end of the insert is the

actual working tip. The stack is made up of flat metal strips

sandwiched together. When the electrical signal is turned on, a

low voltage mechanical signal is generated in the handpiece,

creating a magnetic field of fluctuating intensity. The metal

stack acts like an attenuated antenna that picks up the

magnetic field and causes a rapid vibration which is in turn

transferred to the tip which shatters the calculus as soon as it

comes in contact with the tip.

These units generally operate at a frequency of

25,000 to 30,000 Hz. The tips of these instruments have four

working surfaces and these four surfaces are active at different

speeds with energy dissipation decreasing in descending order

from the tip end, front surface and the sides. The tips of

magnetostrictive scalers have a large amplitude of stroke which

also results in a higher power. As the power/amplitude

increases the patient comfort decreases.

The tips are available in a variety of ranges

and the thick tips can be used on higher power settings, but

the thin tips should be preferably used only with a very low

power setting. The larger tips make it pretty difficult to access

furcation areas and hence Dentsply has introduced a slim line

series of tips to be able to access such areas.

Of all the classes of power scalers, these

generate the maximum amount of heat. Close to 60% of the

electrical energy is lost in the form of heat energy. A resultant

of this great amount of heat production is the necessity of a

copious amount of water for the purpose of cooling the tip. A

positive fall out of the copious water is the cavitation and

irrigation of the pocket during the debridement.

Cavitation is the phenomenon by which


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numerous bubbles which eventually collapse, producing shock

waves in the liquid causing the cavitation with a flushing

action. This cavitation has been known to demonstrate cell-

wall rupture, which results in removing deposited bacterial

endotoxim from the root surface. Units are available in which

the water can be replaced by a medicated solution to be

delivered into the pocket while debridement from an attached

reservoir. A negative effect is the aerosol which is produced

requiring high speed suction units and controlled asepsis.

These units are standardly available as fixed

frequency units. A few of them are also available with a

variable manual tune frequency mode. This variable frequency

allows for alteration of energy, frequency and the amount of

water. These setting have to be optimized for various uses and

different locations. The technology of these system vibrations

can be detected in the handpiece where the metal stacks are

vibrate at a rapid frequency. Even though the human ear

cannot decipher sound at a range of 25000 Hz the sound

generated by the contact of the tip to the tooth can be quite

bothersome.

A very new system available is the sustained

performance system from Dentsply, which involves the

stabilization of the insert stroke levels at all power settings. A

specially designed dual-loop feedback circuitry allows the

insert to talk to the scaler during prophylaxis. The system

responds immediately to the inserts needs and clinical power is

not lost when the insert tip touches the tooth surface. This

allows the insert tip to maintain its stroke and frequency at all

power settings, even in the presence of tenacious calculus.

With a lower stroke and controlled power settings there is a

greater comfort to the patient. A temporary power boost can be

provided for very tenacious calculus by pressing the foot

control in the fully depressed position.

Dentsply is one of the original companies which

brought out the magnetostrictive scaler. The other major

brands available are the Parkell scaler and the HSP Sonic II. A

unique design of magnetostrictive scaler is the Odontoson from


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Goof. It has a ferrite core rod instead of the stacked metal

insert. This scaler operates at a constant 42,000 Hz frequency.

They have a rotational work pattern and all the sides are

equally active. Stacked metal inserts have only about 6 mm of

an active surface; the ferrite rods have upto 13 mm of active

surface length. Another excellent benefit is that less than 3% of

the energy is converted into heat. It does have a water

irrigation line which is basically used for its benefit of

cavitation and irrigation rather than cooling. This scaler does

not require a foot pedal since an electronic swith is located on

the handpiece itself which comes on as soon as the tip touches

the tooth surface. All the components of this scaler are

autoclavable. The reservoir and pump is located outside of the

scaler and only an electrical supply is required to get it up and

running. The insert tips are made of titanium which increases

the life span of the tip. Another unique aspect of this scaler is

the least amount of amplitude, about 0.1 to 0.2 mm from the

centre. One negative of this scaler is that the Ferrite insert is

very brittle and tends to break very easily with the slightest

impact.

3. Piezo Electrical Scalers: This class of scalers uses a crystal

system to transfer electrical energy directly to magnetic energy

without and magnetic interface. The scalers have a piezo

ceramic drive mechanism that produces a horizontal tip

movement in a back and forth stroke. The handpiece of these

class of scalers is the most ergonomic in utility. The units have

crystals within the handpiece that become distorted by the

incoming electrical current to create vibratory energy which is

translated to the insert tip. There is almost no loss of energy in

this process and hence negligible heat production.

These scalers are the first scalers to have the

potential to work at frequencies of upto 45,000 Hz but

generally are available at fixed frequencies of 32,000 Hz. Since

these tips vibrate in a back and forth linear motion, only

lateral surfaces are active. This requires a little bit of

experience and experience in adapting the tip surface properly


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so that the inactive areas are not pressed on the tooth surface.

The scaler creates a vortex action in the periodontal pocket,

allowing the cavitation to progress beyond the tip. The

vibratory motion move plane generates a clean tip motion

without creating interfering vibrations at the lower powers.

This avoids a hammering effect against the root surface while

increasing patient comfort. The crystals expand and contract

about 30000 times per second.

The technique is so important that the more

the lateral force used, the less effective is the instrument due

to the decreased vibratory action. A practical idea is to use the

tip more like a probe rather than a traditional hand scaler or

curette. Newer tips are finer and shaped more like a probe for

easier utility. A new introduction from Satelec has been the

Twiny tip and the Curette tips which are available in two

forms, diamond coated and plain. The twiny tip is a diamond

shaped tip with a larger amplitude of stroke and bilateral water

irrigation. The working surfaces are the lateral surfaces of the

tip. The Twiny is a very efficient tip for excellent and very fast

and efficient removal of gross calculus. A number of clinicians

are of the opinion that the Twiny is the easiest and best tip for

the most rapid removal of supragingival calculus. A word of

caution is that the outer angle of the tip tends to get hot

during actual usage and care should be taken not to allow it to

touch any mucosal surface.

The curette tips are to be used at a low power

setting thereby at a lower amplitude. These tips are to be used

for the final finishing and removal of the very tenacious

calculus which might be supra gingival or subgingival. The

action has to be gentle and very slow. It is imperative not to

allow the fine tip, which is quite sharp to gouge the root

surface and destroy healthy cementum or enamel. These

scalers are generally multifunctional and in addition to

periodontal procedures, they can be used in conventional and

apical endodontic procedures and a few prosthetic procedures.

The leaders of this technology are Satelac and the EMS Piezo

scaler. Other models are the Spartan and the Osada scaler.


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Dear Readers: Important Announcement

The above article by Dr. Ajay Kakar has been published in 3 parts - Part I,

II & III. The above is Part III.

Check Issue L.E.D. Issue September 2016 Vol. 1 Issue 9 for the Ist part

of the above article.

Check Issue L.E.D. Issue October 2016 Vol. 1 Issue 10 for the IInd part

of the above article.





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Teesra Gyaan


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Dr. Parajeeta Dikshit is an Assistant Professor, Department of Pedodontics and Preventive Dentistry (Pediatric Dentistry) at Kantipur Dental College Teaching Hospital and Research Center, Basundhara, Kathmandu and Consultant Pediatric Dentist at Smile Square Dental Care Center, Maharajgunj, Kathmandu, Nepal. She completed her graduation from KGMC Lucknow and MDS from Kathmandu University (KU-MEMG program). She is the joint secretary of Nepalese Association of Pediatric Dentistry. She has a passion for writing and writes articles for online medical journals Medchrome and Pedchrome.

Dr. Senchhema Limbu is an Assistant Professor, Department of Pedodontics and Preventive Dentistry (Pediatric Dentistry) at Kantipur Dental College Teaching Hospital and Research Center, Basundhara, Kathmandu, Nepal. She is also the Consultant Pediatric Dentist at Dharahara dental hospital and Orchid dental clinic in Kathmandu, Nepal. She is the Ex-General Secretary of Nepal Dental Association and presently, General Secretary of Nepalese Association of Pediatric Dentistry.

Early Infancy teeth A Case Report

Author: Dr. Parajeeta Dikshit

Co-Author: Dr. Senchhema Limbu

ABSTRACT

Eruption of teeth in the first three months of birth is a relatively

rare phenomenon. The teeth present in the oral cavity at birth are

known as natal teeth, those which erupt during the first 30 days

after birth as neonatal teeth and the premature teeth that erupt

after 30 days and within 3 months are termed as Early infancy

teeth. The lower incisor region is the most common site of

eruption of these teeth. Early detection and treatment of these

teeth are recommended as they may cause feeding difficulties,

ulceration on the tongue and oral mucosa as well as aspiration or

swallowing. A case of Early Infancy Teeth with healing ulcer on

the tongue in a 40 day old infant is reported in this article.

KEYWORDS

Early Infancy teeth, natal teeth, neonatal teeth, tooth mobility,

extraction.

INTRODUCTION

Eruption of tooth is a major developmental milestone anticipated

by the parents. The timing of eruption though may vary


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depending on hereditary, endocrinal and environmental factors.

At times, first teeth may be present at birth or erupt during the

first or first few months of life. The etiology of this anomaly

remains unknown and is considered to be multifactorial.

Clinically the premature teeth may be normal in size and shape

or may present alterations like conical or shell like crowns, with

enamel hypoplasia or yellow-brownish discoloration. The teeth

may further cause certain complications like pain on suckling to

the mother difficulty in feeding as well as ulcerations on the

tongue for the infants. The early eruption of teeth does not come

easy and is attached to many social taboos considering it to be a

bad omen. In some countries due to various superstitions it

creates anxiety in the parents who want it to be removed at the

earliest.

CASE REPORT

History & Chief Complaint

A 40 days old infant was referred to the department of Pediatric

Dentistry, Kantipur Dental college teaching hospital and research

center, with the chief complaint of erupted lower teeth. The

parents had noticed the teeth 3 days back and reported of ulcer

on the undersurface of the tongue. A Pediatrician had been

consulted for ulceration of the tongue and the infant was under

topical medication for the same. The child was born through

normal delivery with no complications during pregnancy as well

as after birth. He appeared healthy physically and weighed 3

kilograms.

Intra-Oral Examination

The dental examination revealed the presence of two teeth

resembling the central incisors in the mandibular incisor region

(Fig. 1). The crowns of both teeth were rectangular in shape and

white in color without any signs of discolorations (Fig. 2). The

teeth exhibited grade III mobility. The associated gingiva appeared

to be normal. A healing ulcer was present on the ventral surface

of the tongue.


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Fig-1: Intra-Oral Examination View

Fig-2: Teeth resembling Central Incisors

Treatment Plan

The treatment planned was extraction of teeth due to chances of

aspiration.

Treatment Protocol followed

1. The teeth were extracted under topical local anesthesia using

forceps.

2. It was followed by curettage of the socket to remove any

odontogenic cellular remnants.

3. The extracted teeth had slightly developed roots (Fig. 3).


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Fig-3: Extracted tooth with slightly developed roots

4. The procedure was well tolerated by the child.

5. The teeth were sent for histological investigation and it was

reported to have thin dentin with normal appearing pulp and

a faint amount of cementum.

6. Post operative complications were not reported and the ulcer

had healed completely on the follow up visit after 7 days (Fig.

4).

Fig-4: Healed Ulcer after 7 days

DISCUSSION


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Presence of teeth in the oral cavity in the first three months after

birth is rare. Teeth present at the time of birth are Natal teeth

and the teeth that erupt within 30 days after birth are known as

Neonatal teeth. In the above case the teeth erupted after 35 days

of birth so it was categorized as Early Infancy teeth. Early Infancy

teeth are teeth that do not confirm the criteria described for natal

or neonatal teeth and erupt within one to three and a half months

after birth. Early Infancy teeth have been reported rarely and are

less common than natal or neonatal teeth. Some other synonyms

used by authors are Congenital teeth, Fetal teeth, Pre-deciduous

teeth, Premature teeth, Precociously erupted teeth and Dentitia

praecox.

The exact etiology for the premature eruption or for appearance

of natal and neonatal teeth is not known. Earlier the neonatal

teeth were considered cysts of the dental lamina of the newborn

and would occur due to inheritance as dominant autosomal trait.

Infection, febrile states, trauma, malnutrition, superior placement

of tooth germ is considered to be other factors in its etiology.

Multiple syndromes like Ellis-van Creveld syndrome, Pierre Robin

syndrome, Hallermann-Streiff syndrome have been reported to be

associated with this condition though none were noticed in the

present case.

The prematurely erupted teeth occur most commonly in the

mandibular incisors region (85%), followed by maxillary incisors

(11%), mandibular cuspids (3%) and maxillary cuspids or molars

(1%). Kates et al reported sixty-one percent of the subjects had a

pair of natal or neonatal teeth (or both) like in this case.

Morphologically, the premature teeth maybe well developed

or poorly developed with small cone shaped crowns. They may

have a yellowish-brown or whitish opaque color with hypoplastic

enamel or dentin. In our cases the teeth had well developed crown

resembling deciduous incisors with slight root formation.

Hebling classified natal teeth into 4 clinical categories:

1. Shell-shaped crown poorly fixed to the alveolus by gingival

tissue and absence of a root.


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2. Solid crown poorly fixed to the alveolus by gingival tissue and

little or no root.

3. Eruption of the incisal margin of the crown through gingival

tissue.

4. Edema of gingival tissue with an unerupted but palpable

tooth.

Histologically, these teeth have dysplastic or hypomineralized

enamel, irregular dentin and osteodentin in the cervical portions

and interglobular dentin in the coronal regions with rich

vascularization of pulp. The incisal edge might lack enamel.

Hertwig’s sheath and cementum might be absent. In the present

case, histologically dentin and pulp appeared normal while only a

faint amount of cementum could be noted.

Traumatic ulceration occurring on the tongue due to

repetitive trauma by the premature teeth has been termed Riga-

Fede disease. It frequently involves the ventral surface of the

tongue or the lingual frenum as tongue constantly rakes over the

teeth.

For the determination of treatment options, it is essential to

perform radiographic examination to check the amount of root

development and to confirm if the teeth belong to primary

dentition. It was suggested in this case but was declined by the

parents. Excessive mobility, risk of aspiration or swallowing and

discomfort to the infant and to the mother are other factors that

determine the treatment protocol. If the degree of tooth mobility is

more than 2 mm, the natal teeth of category (1) or (2) usually

need extraction. The risk of swallowing and aspiration

necessitated extraction as the treatment of choice for the present

case.

Extraction does not usually pose any difficulties as these teeth

can be removed with forceps or even with the fingers. However,

precautions have been recommended when extracting these teeth

in a child up to the 10th day of life. Vitamin K needs to be

administered before extraction to prevent hemorrhage and

unnecessary injury to the gingiva should be avoided and one has

to be alert during extraction to avoid aspiration.


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Prematurely erupted true deciduous teeth if diagnosed as

a tooth of the normal dentition without any complications should

not be extracted. Incisal edges causing the trauma to mother or

child can be rounded off and the tooth retained. The mobility of

some premature teeth has been noted to decrease with time.

Kates et al found good prognosis for natal and neonatal teeth that

survived beyond 4 months.

CONCLUSION

Premature teeth are relatively rare with multiple causes

attributed to its development. They may or may not be associated

with syndromes. The treatment should be based on the symptoms

or complications presenting with it. A multidisciplinary approach

between pediatricians and pediatric dentist is required to manage

such cases appropriately.

REFERENCES

1. Jingarwar MM, Bajwa NK., Pathak A. Riga Fede Disease:

Fibrous Hyperplasia Associated with Natal Teeth in an Infant –

A Case Report and Clinical Update. Indian Journal of Neonatal

Medicine and Research Jul 2014; 2(1): 11-13.

2. Mamta Malik, Ravinder Singh Saini, Rahul Jain, Sanjeev

Laller. A Comprehensive Update: Predecidous Teeth (Natal and

Neonatal). Journal of Advanced Medical and Dental Sciences

Research April-June 2014;2( 2) :90-94.

3. Anegundi RT, Sudha P, Kaveri H, Sadanand K. Natal and

neonatal teeth: A report of four cases. J Indian Soc Pedod Prev

Dent 2002; 20(3):86-92.

4. Ertas ET , Sekerci AE, Sisman Y, Sahman H, Etoz M. Natal

Teeth: A Report of Three Cases. J Oral Health Comm Dent

2013;7(2):127-131.

5. Nitin Sharma, Subhash Chander, Shweta Soni, Shamsher

Singh, Madan Gopal Chodhary.Riga-Fede Disease Due to

Neonatal Tooth: A Case Report. International Journal of Oral &

Maxillofacial Pathology 2012; 3(2):43-44.


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6. Shubhangi Mhaske, Monal B. ,Yuwanati, Ashok Mhaske, Raju

Ragavendra, Kavitha Kamath and Swati Saawarn. Natal and

Neonatal Teeth: An Overview of the Literature. ISRN Pediatrics

2013; vol 2013(Article ID 956269): 11 pages.

7. Cunha RF, Boer FAC, Torriani DD. Natal and neonatal teeth:

review of the literature. American Academy of Pediatric

Dentistry 2001; 23: 158-162.

8. Sumedh S. Khare, Rahul Hegde, Namrata Mathrawala.

Neonatal Teeth: A Report of Three Cases. Indian Journal of

Dental Sciences June 2014;6 (2):89-90.

9. Nalam Sai Gautam, N. Radhika Gautham. Natal Teeth – Report

of Two Cases. Adv Hum Biol 2014; 4(2):81-84.

10. Chow MH: Natal and neonatal teeth. J Am Dent Assoc 1980;

100: 215-6.

11. Vaishali Shende,Sandhya Srivastava, Aruna Holani, Ranjit

Patil. Natal Teeth: Clinical study of seven cases. Journal of

Indian Academy of Oral Medicine and radiology Oct-Dec

2011;23(4) : 654-5.

12. Kates GA, Needleman HL, Holmes LB. Natal and neonatal

teeth: a clinical study. J Am Dent Assoc 1984; 109:441-3.

13. Swati Chowdhary,Sandeep Tandon. Congenital teeth:

Superstition and Reality – A Case Report and Review of

Literature. International Journal of Scientific Study Feb 2014;

1(5):53-56.

14. Shalini Gupta, Kavita Nitish Garg, Divya Mehrotra and O P

Gupta. Natal Teeth: A Clinical Report. Asian Journal of Oral

Health & Allied Sciences Jul-Sep 2011;1(3): 205-8.

15. Hebling J, Zuanon ACC, Vianna DR. Dente Natal-A case of

natal teeth.Odontol Clín 1997; 7(1): 37-40.

P.S. Any feedback/compliments/queries for the Author should be

emailed to the Editor-in-Chief, Dr. Bhavdeep Singh Ahuja at his

email id: [email protected]


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Chautha Gyaan


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Dr. Abhijeet Bhasin completed his graduation from Modern Dental College and Research Center, Indore in 2007. He had his basic and advance implantology training from Goethe University, Germany and has been practicing Oral Implantology since the past 8 years. He is Member, Indian Society of Oral Implantology (ISOI). He is Vice President (WAUPS) South East Asia. He maintains a dedicated Dental Implant Center and an Implant Training Academy in Indore.

Ridge Split Technique and Bone Expansion Osteotomy

For Successful Rehabilitation

Author: Dr. Abhijeet Bhasin

ABSTRACT

Lack of sufficient bone to place an implant in a functionally and

esthetically appropriate position is a common problem in a

narrow edentulous alveolar ridge. Less than 5 mm bucco-

palatally/bucco-lingually posses a problem for the implant

supported restorations. Ridge split technique seems to be a

reliable and simple option with less morbidity and satisfactory

rehabilitation. Survival and the success of the implants placed

with this technique were consistent with those placed in non

reconstructed bone.

KEYWORDS

Ridge Split, Bone Expansion, Tooth Loss.

INTRODUCTION

Dr. Hilt Tatum 1970’s introduced a method of the ridge splitting

or bone spreading which over a period has been used in implant

dentistry for esthetic rehabilitation and implant bed preparation

in cases of deficient alveolar ridges to satisfy the basic ideal need

for the hard tissue augmentation for functional and esthetic

outcome of implants. Ridge split procedures are commonly

performed for horizontal augmentation of narrow ridges which

would otherwise preclude implant placement.

The labial alveolar bone often undergoes rapid reconstruction

after natural tooth loss with approximately 25% decrease in

volume during 1st year, followed by 40-60% decrease in width in

following next 3 years leading to the labial cortex of bone more

medial than its original position. Loss of bucco-palatal dimension

of ridge further necessitates calls for additional procedure to

receive optimum implant borne prosthesis. Management of such


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defect becomes still critical in esthetic zone. Thus due to this

sequel of resorption after tooth loss jeopardizes the functional and

esthetic outcome of treatment.

SEIBERT’S CLASSIFICATION OF RIDGE DEFORMITIES

1. Class I – Bucco-lingual loss of tissue contour with a normal

apico-coronal height.

2. Class II – Apico-coronal loss of tissue with normal bucco-

lingual contour.

3. Class III – A combination of bucco-lingual and apico-coronal

loss.

4. Ridge described according to the depth of loss: Mild

Less than 3 mm.

5. Ridge described according to the depth of loss: Moderate

Around 3-6 mm

6. Ridge described according to the depth of loss: Severe

Greater than 6 mm

7. Class N: Normal: Minimal height and deformity 9% of all

edentulous ridges

The segmental ridge split procedure (SRSP) creates a crypt

surrounded by bone and periosteum into which implants and

bone graft material can be introduced with reasonable

predictability so that new bone can be constructed which

provides a solid base for dental implant to seat in.

PRE SURGICAL ASSESSMENT

Patient should be healthy and mentally adjusted for the

placement of implants. Patient with poor oral hygiene is NOT the

candidate for the procedure. Patients radiographic records e.g.

OPG, CBCT help in proper assessment of the bone width and

bone quality. The pre-operative intra-oral picture showed thin

and narrow ridge with significant reduction in the bucco-lingual

dimensions (Fig. 1 & Fig. 2).


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Fig-1: Pre-Operative Clinical View

Fig-2: Pre-Operative Clinical View

MATERIAL & METHODS

1. Bone cutting disc, sharp bone chisel were used for performing

ridge splitting procedures described here.

2. A surgical mallet is necessary along with other surgical

instruments that are comfortable to the surgeon.

3. The space between the plates is generally grafted with the

DFDBM combined with autogenous bone when possible.

SURGICAL TECHNIQUE

1. The pre operative medication were given 90 minutes prior to

the surgery which included Amoxicillin 500mg, Ibuprofen

600mg, Dexamethasone 4mg. Chlorhexidine Gluconate 0.12%

oral rinse and Perioguard from Colgate was also prescribed.


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2. A mid-crestal incision was given with BP Blade No. 15

through out the edentulous area (Fig. 3).

Fig-3: Mid-Crestal Incision

3. A gentle full thickness flap reflection was done and the bone

was measured with bone measuring caliper at different sites

which helped in determining the amount of available bone bed

and the requisite bone expansion to be done (Fig. 4).

Fig-4: Bone Measuring with the Caliper


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4. Crestal corticotomy was done with bone trimming burs (by

ADL Bio) to create a platform for the split with rotary disc (Fig.

5).

Fig-5: Crestal Corticotomy

Fig-6: Horizontal Cut over the prepared bone bed


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5. The horizontal cut was given over the prepared bone bed, with

the use of the sharp chisel and the initial separation of the

two cortical plates was done (Fig. 6).

Fig-7: Ridge Expansion in Progress

Fig-8: Ridge Expanded with Chisel and Mallet


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6. The use of a narrow chisel is recommended which upon

penetrating (by impacting) into the marrow spaces induces

vestibular expansion of the oral cortical process (Fig. 7 and

Fig. 8).

7. The pilot drill was used to prepare the osteotomy site.

Fig-9: Noris Implant being inserted into Osteotomy Site

Fig-10: Noris Implant being inserted into Osteotomy Site

8. On confirmation with the X-ray, the sequential drilling till the

required length and width of the implant is been done


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simultaneously Three Noris Medical Implants of sizes 3.75 by

11.5mm ONYX (44), 3.75 by 11.5mm TUFF (45) and 4.2 by

11.5mm TUFF (46) were placed followed by cover screw

placement (Fig. 9, Fig. 10, Fig. 11 & Fig. 12). Bone graft from

Allograft from Tata Memorial Hospital was used.

Fig-11: Noris Implants with cover screws

Fig-12: Implants as seen on the Post-Operative X-ray


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9. Periosteal releasing incisions were given for better adaptation

of the flaps and horizontal sutures were placed at the crestal

region followed by interrupted sutures in between them.

10. Postoperative instructions were given to the patient.

11. After four months of healing, a sufficient bone gain in bone

width was noticed (Fig. 13).

Fig-13: Gain in Bone width after 4 months of healing

12. Gingival sulcus formers were placed.

13. Abutment level impression was taken and porcelain fused to

metal prosthesis was cemented (Fig. 14 & Fig. 15).

Fig-14: PFM Crowns in place


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Fig-15: Crowns in Occlusion

Fig-16: One Year Radiographic Follow up

14. Oral hygiene maintenance instructions were given and one

year follow up X-ray showed a stable bone level at the implant

surface (Fig. 16).

DISCUSSION

The posterior mandible is the most difficult region for

reconstruction and early implantation in cases of severe alveolar

resorption in the maxillo-mandibular complex. Onlay grafting

with biodegradable membranes and autografts is the most

frequently used technique; however, this technique involves a

long ossification period, and the tendency of the graft material to

resorb can easily decrease bone quality and quantity. Time lost


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and donor-side morbidity are the main disadvantages of this

reconstructive approach. The split-crest technique should be

delineated as a bone expansion procedure, which potentially

eliminates the overall disadvantages of Onlay grafting for esthetic

and functional demand, with the advantage of a shorter treatment

time. Careful preparation of the bone and maintenance of an

attached periosteum are critical to the formation of new bone

around the interproximal surfaces of the implants. Wound

healing in these cases is similar to the fracture repair of bone.

The gap is filled with a blood clot, which is organized and

replaced with woven bone and further matures into load-bearing

lamellar bone at the implant interface. The ridge splitting

technique is used to expand the edentulous ridge for implantation

or insertion of inter-positional bone graft.

Significant advantages of ridge expansion rather than Onlay

grafting include simultaneous implant placement and grafting,

lower cost, lower possibility of cross-infection from graft materials

and lower morbidity. This technique has greater predictability,

since the grafted area is essentially a five-wall bony defect, with

excellent blood supply. This technique is only suitable for

enhancing ridge width. There must be adequate available bone

height for implant placement, and no vertical bone defect should

be present. A minimum of 3 mm of bone width, including at least

1 mm of cancellous bone is desired to insert a bone chisel

between cortical plates and consequently expanding the cortical

bones. The thinner cortical plates and softer medullary bone

make the maxillary ridge easier to expand. The risk of malfracture

of the osteotomized segment is high in the mandible due to

thicker cortical plates.

The disadvantage of this procedure is that if the

complication arises and bone loss occurs, the patient is left with a

larger bone defect than before. If favorable conditions are not

present, clinician might prefer Onlay augmentation. Therefore,

appropriate case selection and surgical technique is of great

importance when considering the application of this technique.

CONCLUSION

The present case demonstrated that none of the implants placed

in the bone gap created by ridge expansion was lost and all were

successfully osseointegrated. Hard as well as soft tissue


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structures revealed favourable and stable results with a follow-up

of one year. Overall, the advantage of this treatment procedure

was the ability to insert dental implants into a much

compromised bony site in a simultaneous procedure, meaning

only one operation in total with less total healing time compared

to the established treatment methods. But like with other delicate

surgical techniques, the ridge splitting stabilization technique

appears to be more user sensitive.

REFERENCES

1. Basa S, Varol A, Turker N. Alternative bone expansion

technique for immediate placement of implants in the

edentulous posterior mandibular ridge: a clinical report. Int J

Oral Maxillofac Implants. 2004;19(4):554–8.

2. Misch CM. Implant site development using ridge splitting

techniques. Oral Maxillofac Surg Clin North Am. 2004;16(1):65–

74.

3. Ignatius AA, Ohnmacht M, Claes LE, Kreidler J, Palm F. A

composite polymer/tricalcium phosphate membrane for guided

bone regeneration in maxillofacial surgery. J Biomed Mater Res.

2001;58(5):564–9.

4. Hollinger J, Wong ME. The integrated processes of hard tissue

regeneration with special emphasis on fracture healing. Oral

Surg Oral Med Oral Pathol Oral Radiol Endod. 1996;82(6):594–

606.



his email id: [email protected].


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Paanchwaa Gyaan


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Dr. Mayur Davda is the pioneer of training and research at dental photography school and has extensively lectured on documentation at various dental associations and universities across India. He has a long list of firsts to his credit like, the first dentist to exhibit at India’s most prestigious art gallery – The Jehangir, first dentist to exhibit at Kalaghoda art festival, first dentist to be interviewed by Better Photography and Smart Photography magazines & first dentist to be interviewed on national television just to name a few. Considered as one of the finest dental photography experts in the world he has also participated in Portugal dental congress dental photography art exhibition and the only one to represent India. He has won several awards for fine art and wildlife photography and was invited by the Consulate General of Turkey on the National day (2015) for commendable contribution in the field of photography. Famdent Awards has honored him as the highly commended Indian dental talent of the year 2015. He is currently the photomentor for GPS smile design (Las Vegas, USA) and CANON India. To know more about Dr. Mayur Davda you can visit www.mayurdavda.com, www.dentalphotogrraphyschool.in, www.thedentaleducation.com, www.liquidcanvas.in.

PHOTODONTICS – XI

Introduction to the World of Lenses!!!!!!

An Enigma or a Reality?

Author: Dr. Mayur Davda

Continued from Vol. 1 Issue 10

In our previous articles we have discussed about DSLR cameras,

intra oral accessories etc. It is equally (or probably more)

important to have a good lens for dental photography.

We discussed in short about the basics of lenses in L.E.D.

March 2016 Vol. 1 Issue 3; let’s explore the world of Lenses

in a bit more elaborate manner.

INTRODUCTION

A 100 mm macro lens is considered ideal for dental photography.

DSLR cameras have an edge over other cameras like point and

shoot/bridge cameras because of the capability to interchange

lenses. This makes the entire DSLR system extremely versatile.

Once you buy a DSLR Camera, you can specialize in ANY genre of

photography and you just need to have the right lens for it.

(which you can buy separately as per your requirement)

A lens is made up of concave/convex/concavo-convex

glasses and motor inside it. There are a large number of lenses

available in the market hence you need to understand lenses

before you buy one.

This article shall try to focus on what are the different options

available for good dental documentation and in order to


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http://www.mayurdavda.com/

http://www.dentalphotogrraphyschool.in/

http://www.thedentaleducation.com/

http://www.liquidcanvas.in/

understand that, we first need to understand the BASICS of

Lenses.

BASICS of LENSES

In order to understand the lenses and their use, we need to first

understand “Focal length of the lens”

Focal length of the lens:

A lens’ focal length is defined as the distance between the lens’

optical center and the camera’s image sensor when focused at

infinity.

It’s the distance between the point of convergence in your lens to

the sensor or film in your camera.

(Image Courtesy: Google)

Focal length of the lens is clearly written in BOLD on the lens

E.g. the lens below is called as a 18-55 lens.

(Image Courtesy: Canon India)


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Based on the focal length lenses are classified as follows:

1. Wide Angle Lenses

2. Standard Lenses

3. Telephoto Lenses

Wide Angle lenses: Lenses having a focal length of less than 45

mm.


Standard/Normal Lenses: Lenses having a focal length of 45 –

55 mm



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Telephoto Lenses: Lenses having focal length of more than 55

mm


USES

1. Wide Angle lenses have a wider angle of view and hence they

cover a larger area in front of the camera.

2. These lenses are used for Landscape photography/

architecture photography/taking images of a large group of

people etc.

3. A standard lens is useful for Portraits/ food photography etc.

4. A telephoto lens has a very narrow angle of view and is useful

to shoot objects which are far away from us for e.g. in wild life

photography, photography of birds, craters of the moon etc.

Prime Lenses:

1. Lenses having a SINGLE focal length.

E.g: Canon 50 mm

2. Note that these lenses could be wideangle, standard or

telephoto.


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Zoom Lenses:

1. Lenses with zoom in-zoom out options and which can be

focused at various focal lengths.

E.g. Canon 18- 55 lens

2. Although it might be tempting to buy a ZOOM lens

(considering it is more versatile) but it’s important to know

that these lenses are “Jack of all trades and master of none”.


It’s always advisable to buy a prime lens for a particular use

(genre of photography) than buy a zoom lens which can cover a

lot of versatile uses.

This may increase the number of lenses that you need to carry

but the images captured by a prime lens are way more superior to

a zoom lens.


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Parts of a Lens


1. Focusing ring helps you focus manually in manual focusing

mode.

2. Focal length ring helps you set your lens at the desired focal

length.

3. Auto focus button / auto focus focuses automatically when

you half click the shutter release button on your camera.

4. In a PRIME lens there is NO focal length ring as we cannot

change focal lengths.

5. The only ring in a PRIME lens is the focusing ring with which

you can focus on the object.



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Now coming back to Dental Photography

6. We use a SPECIAL lens called a MACRO lens in dental

photography. But WHY is this lens called a SPECIAL LENS?

7. Macro lens is the only lens which is capable of shooting

objects at a very close distance. In other words the lens is

engineered in such a way that the minimum focusing

distance of the lens is very short. Sounds confusing?

The following example will help you understand it better…

(Image Courtesy: Dr. Mayur Davda)

Suppose we had to make an image of 2 central incisors like in the

image above.

8. A macro lens allows us to come as close to 6 inches to the

tooth and shoot the image. (The above image was made using

a Canon 100 mm MACRO lens at a magnification of 1:1.)

9. On the contrary if we would have shot the same image using a

routine (NON MACRO) 100 mm lens then the closest we could

have come to the patient would be approximately 2 feet.

10. The huge distance of 2 feet (approx.) would make it extremely

difficult for us to make dental images.

(Imagine making an image of a third molar from a distance of

2 feet!!)

11. Also note that the flash power falling on the teeth would be

very feeble as the distance (2 feet) would be too large and this

would result in underexposed images (at desired camera

settings).


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12. Another advantage of MACRO lenses is that it gives razor

sharp images of the object in focus; way more than a non-

macro lens could.

13. The major advantage of a MACRO Lens is that it can give us

consistently similar looking images which is a pre requisite for

our before after documentation protocol.

14. This magic happens by the help of MAGNIFICATION ratios.

15. MACRO LENSES are the only lenses in the world which can

help you work in what is called as magnification ratios.

What is MAGNIFICATION RATIO and how to use it for

dental photography?


Every macro lens is equipped with a dial which looks like this



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The “1: in yellow” is the magnification ratio indicator. When you

rotate the focusing ring you will see that the magnification rations

can be changed from 1:1 (extreme close up) to infinity. Thus you

can make images at various magnification ratios of your choice

like 1:1, 1:1.5, 1:2, 1:3, 1:5 etc.

Typically, 1:1 is used for extreme close up images

(the area of coverage at 1:1 is only 4 teeth)


As we reduce the magnification ratio, the number of teeth keeps

on increasing in our image. The following (below) image was made

at 1:1.5 magnification:



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At 1:2 you get to see more number of teeth as compared to 1:1.5


At 1:3 you get to see the entire arches


This is how we apply magnification ratios in dental photography.

(Image Courtesy: Aum Dental Clinic)


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Thus if you want consistently similar looking images, JUST SET

THE MAGNIFICATION FIRST using the focusing ring and then

shoot.

Consistently similar looking series of images do better justice

to the work a dentist has done. In order to compare the pre-

operative and post-operative image it is imperative that both

images look the same in composition.

This is possible by the use of magnification ratios and macro

lenses only.

Hence if you have made a pre-operative image using a

magnification ratio of 1:1, it is suggested that you make the entire

operative and post-operative images at the same magnification.


As all good things come to an end one day, Dr. Mayur Davda,

the Dentist Photography Guru of India will be winding up his

dedicated column on Photography next month with his last article

in December 2016 in our E-Journal.

We will Miss You!!!! Mayur





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Chhathaa Gyaan


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Dr. Rita Singh is a graduate of Bangalore in 1997 and a Post graduate in Periodontics in 2001 from Rajiv Gandhi University of Health & Sciences, India. She has also completed her Masters in Implantology with Dental XP and Stony Brook School of Dental Medicine. Currently, She is an Associate Professor in the Department of Periodontics in Kathmandu Medical College, Sinamangal. Dr. Lanka Mahesh is an implantologist practicing in New Delhi. He is a Fellow and Diplomate of International College of Oral Implantologists (USA) and the Indian Society of Oral Implantologists. He has undergone advanced surgical training at USA and Spain. He has also authored “Practical Guide to Implant Dentistry” published by Quintessence. He has lectured extensively in India and abroad and has numerous publications on implant related topics.

Dr. Sagrika Shukla is an MDS in Periodontology and is presently attached as a Senior Lecturer in Seema Dental College and Hospital, Rishikesh. She has many national and international publications to her credit. She is also a Fellow and Diplomate of the International Congress of Oral Implantologists (ICOI-USA)

Infections Resulting from Bone Grafting

Biomaterials A Review

Author: Dr. Rita Singh

Co-Author 1: Dr. Lanka Mahesh

Co-Author 2: Dr. Sagrika Shukla

ABSTRACT

Use of bone grafting is a boon in saving ailing and failing bony

structure. Today in dentistry all types of grafts are used,

autogenous, xenografts, allografts alloplasts, all giving favorable

results. Yet, all have demerits. Xenografts and allografts have

high chances of transmission of infection. This article highlights

grafts and transmission of such infections.

KEYWORDS

Infections, Xenografts, Allografts

INTRODUCTION with DISCUSSION

Bone grafts are extensively used in dentistry for reconstruction of

atrophied alveolar ridges, around endosseous implants for

regeneration of missing bony wall to provide support and stability

to implants, for sinus floor elevation procedures, for healing of

intrabony peri-implantitis defects, in periradicular surgery and


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large periapical lesions, in periodontal bony defects and for

reconstruction of maxillofacial defects. There are various bone

grafts used in dentistry. The best being autografts, however, the

chance of second surgical site, limited amount and their rapid

resorption has encouraged clinicians to use xenografts or

allografts.

XENOGRAFTS

Xenografts are grafts shared between different species. There are

many available sources of xenografts used as bone replacement

grafts: Bovine bone, porcine bone, horse bone and natural coral.

The advantage of theses grafts is that they are osteoconductive

and undergo through extensive processing techniques, providing

products which are biocompatible and structurally similar to

human bone. Other advantages include readily availability and

risk free of disease transmission; however ‘risk free of disease

transmission quotient’ has been questioned with the discovery of

bovine spongiform encephalopathy (BSE) and porcine endogenous

retroviruses (PERVs). Xenotransplantation may allow such

organisms to infect xenograft recipients, who may, consequently,

contract previously unknown diseases.

There is also a risk that the infectious organisms might cause

disease and destroy the transplanted organ, even if they do not

harm the human recipient. Even if not infected with disease-

causing organisms when transplanted, the xenografted organ may

remain susceptible to infectious organisms of animals. Also, if a

xenograft recipient is infected, there is a possibility that the

resultant disease might then be passed on to the public. In this

way, xenografting may pose a risk to public health as well as to

individual health.

ANORGANIC BOVINE-DERIVED BONE XENOGRAFT (BDX)

The BDX is a xenograft consisting of deproteinized, sterilized

bovine bone with 75 to 80% porosity and a crystal size of

approximately 10 mm in the form of cortical granules. The

advantage of BDX is that it has osteoconductive properties and

according to Cohen et al and Callan et al use of this graft material


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is considered safe since all the proteins are removed and is 100%

crystalline hydroxyapatite grafting material. Yet, there are

reported cases of BSE (Bovine Spongiform Encephalopathy).

Infectious particles cause BSE in cattle, when these are

accidentally transplanted in humans through bone grafts they

cause Creutzfeldt-Jakob disease (CJD) and a variant of

Creutzfeldt-Jakob disease (vCJD). CJD is a rare, fatal

neurodegenerative disorder of old age, but its variant vCJD can

occur at any age. The occurrence of CJD is rare approximately

one case per million populations. The disease is caused by prions,

which are considered to be composed mainly of an altered normal

protein (prion protein). It is also known as the prion disease. It

was first discovered by Stanley B Prusiner, and he defined prions

as infectious, transmissible proteinaceous particles that lack

nucleic acid and are composed exclusively of a modified isoform

of the noninfectious cellular prion protein (PrPC). The pathogenic

(also called scrapie or PrPSc) form of the prion protein (PrP) has

the same amino acid content but a higher -sheet content than

PrPC. These prions get deposited in cerebrum and cerebellum

causing sponge-like degenerative changes in the brain. Clinical

features include psychiatric symptoms such as depression,

anxiety, apathy, withdrawal, delusions; there is persistent painful

sensory symptoms pain and/or dysesthesia, ataxia, chorea/

dystonia or myoclonus, dementia. Oral manifestations include

pseudobulbar palsy which may cause dysphagia and dysarthria

in patients with transmissible spongiform encephalopathies

(TSEs), orofacial dysesthesia or paresthesia, as well as loss of

taste and smell. There are various types of CJD:

Table 1 below describes those types.

Table:1 – Various forms of Creutzfeldt-Jakob Disease


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There are many reported case of transmission of BSE, although

the risk of transmission of CJD through dentistry is unclear, the

theoretical risk of transmission through any contaminated

instruments or contaminated bovine bone graft can take place.

Incidence of transmission of BSE with bovine xenograft is

estimated to be far less than the incidence of being hit by

lightning. Therefore, the risk of getting disease transmission from

allograft and xenograft is relatively low as long as the

disinfection/sterilization protocols are followed by the suppliers.

World Health Organization stated that bone is labeled as type IV

(no transmission) for proteinaceous infectious particles (prions)

diseases. All current available bone graft materials are safe and

reliable instead of disease transmission potential. According to

Sogal and Tofe, the risk of TSE transmission from a commercially

available bovine-derived xenogenic bone substitute was

insignificant. In animal studies, Adams and Edgar assessed the

possibility of transmission of scrapie through dental burs. They

found no clinical or histological findings of scrapie when the

healthy mice were killed and examined 15 months later. Ingrosso

et al conducted a study on the possibility of prion infection

through dental procedures. They found a significant level of

infectivity in the trigeminal ganglia and in the gingival and pulpal

tissues of scrapie-affected hamsters after intraperitoneal

inoculation, suggesting possible transmission from the central

nervous system through trigeminal nerves toward the oral cavity.

PORCINE BONE GRAFTS

The pig has a number of advantages as a renewable source of

donor tissue including a vast experience in its husbandry and

health care, as well as the advancing technologies to engineer

transgenic animals thus, porcine bone grafts are widely used in

dentistry, selective breeding and screening of the pig can reduce

the risk of animal-human infections, from xenotransplantation.

However, pigs harbor many viruses or ghosts of viruses, some

active, some latent and others represented only by a partial

genetic sequence embedded in the pig genome such as

endogenous retroviruses PERV, which are encoded in their


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genomic DNA and are thus in every cell of every pig, and are

therefore less susceptible to exclusion by careful breeding. There

are at least three variants of PERVs (A, B, B1 and C) in native pig

cells. PERV-A and PERV-B can infect several species including

humans, while PERV-C tropism is limited to pig cells. However,

recombination between PERV-A and PERV-C occurs frequently

producing a high titer, human tropic PERVA/C, these are

considered to be most problematic as they use the same cell

receptor as PERV-A and are the forms derived from co-cultivation

of porcine primary cells and human cells. PERVs infect human

cells in vitro and have been cloned. Recent data suggest that

despite the presence of many fragmentary copies of virus

sequences, there are relatively few; full length copies of the viral

DNA in each cell that are capable of producing infective virus. In

addition, some genomic sites produce incomplete viral

transcripts, which are not thought to be infective. This small

number of intact genes might allow inactivation of proviruses of

PERVs through genetic manipulation. Gammaretrovirus particles

are released by pig cell lines, yet only recently have investigators

looked into the potential risk of human infection by PERV. Two of

the three identified receptor classes of PERV, distinguished by

their envelope sequence and tropism, have been shown to be

capable of replicating in human cells in vitro. In vivo, they may

cause infection and may give rise to two possible effects:

mutagenesis and immuno-suppression. The first may induce

cancer. The second will damage the human immune system and

in analogy to HIV and SIV, high titer virus replication may cause

an AIDS-like disease in the immuno-suppressed human

transplant recipient. Pig cells can survive for many years in the

human body and micro-chimerism has been detected. In

microchimerism, the pig cells in the human body contain PERV

but—if no infection has occurred—no virus particles have been

incorporated rated in the human genome. This however does not

decrease the risk that PERV may cause. Whether one can really

distinguish between microchimerism and an infection is not clear.

Another infection that humans can acquire from pigs is Ebola

virus (EBOV). EBOV causes extremely severe disease in humans


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and in nonhuman primates in the form of viral hemorrhagic fever.

EBOV is a select agent, World Health Organization Risk Group 4

Pathogen (requiring Biosafety Level 4-equivalent containment).

EBOV was first described in 1976 by David Finkes. Today, the

virus is the single member of the species Zaire ebolavirus, which

is included into the genus Ebolavirus, family Filoviridae, order

Mononegavirales. The name EBOV is derived from the Ebola River

(a river that was at first thought to be in close proximity to the

area in Zaire where the first recorded EBOV disease outbreak

occurred) and the taxonomic suffix viruses. It causes a

fulminating hemorrhagic fever syndrome resulting in the death of

most patients within a few days. Human immune responses have

as yet been poorly investigated, mainly due to the fact that most

outbreaks occur in remote areas of central Africa. In infected

humans, there is fatal outcome in humans and is associated with

aberrant innate immunity characterized by a ‘cytokine storm,’

with hypersecretion of numerous pro-inflammatory mediators and

by the noteworthy absence of antiviral interferon. The adaptive

response is globally suppressed, showing a massive loss of CD4

and CD8 lymphocytes and the immune mediators they produce.

EQUINE DERIVED BONE GRAFT

There is always search for better bone grafts resembling human

bone matrix and capable of osteoconductive properties. With

discovery of PERV through porcine bone grafts and CJD through

bovine bone grafts, use of equine bone grafts has become popular.

However, research on risk on disease transmission through

equine is still being investigated. El-Sabban et al stated that there

are no studies on bone substitutes of equine origin, apart from

few papers on an equine bone protein extract, which was capable

of inducing osteoblastic differentiation of human bone marrow-

derived mesenchymal stem cells and ectopic bone formation in a

rat model. According to Stefano et al equine graft material is

biocompatible, and its usage is associated with new blood vessels

ingrowth during healing, which has been found to be extremely

important in bone formation. The status still remains the same.

There is rapid increase in use of equine bone grafts; however,


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research disease transmission through this material needs more

attention.

HUMAN DURA MATTER

Allografts have been successfully used for intraosseous defects,

most common being decalcified freeze dried bone allograft

(DFDBA), however, controversy exists with respect to the

osteoinductive potential of these materials. It has been shown

that inductive capacity varies from bone bank to bone bank and

also from different batches of the same bone bank. The bioactivity

is also dependent on the age of the donor, the younger the donor,

the more osteoinductive graft material will be. Also there are

chances of disease transmission, the most common being

Creutzfeldt-Jakob disease, which can be transferred from an

infected donor. The main disadvantage is that this disease

transcripts as a preclinical state in which it can lie dormant in

the individual for decades (1-40 years), also it cannot be detected

in human blood. These factors increase the chances of

transmission as it goes undetectable on screening. According to

Gajdusek et al, another subacute spongiform encephalopathy,

survived room temperature in 10% formalin for 7 months in the

form of a brain suspension.

CONCLUSION

With various bone grafts in has now become possible to reach the

goal of bone regeneration and achieving ultimate results providing

both function and esthetics. However with the use of xenografts

the risk of disease transmission increases. Although till now no

case of infection from xenotransplantation in dentistry has been

reported, but there is a risk. And to avoid certain precautions can

be taken by the dentist. Patients with confirmed prion disease

should be scheduled at the end of the day to permit more

extensive cleaning and decontamination. It is preferable to avoid

activating waterlines because of the risk of retraction of prions in

oral fluids. Also, a stand-alone suction unit with disposable

reservoir, rather than the suction component of the dental unit,

and a disposable bowl instead of the dental unit spittoon should


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be used. To avoid environmental contamination, dental

equipment should be adequately shielded using disposable,

impermeable cover sheets.

REFERENCES

1. Cohen RE, Mullarky RH, Noble B, Comeau RL, Neiders ME.

Phenotypic characterization of mononuclear cells following

anorganic bovine bone implantation in rats. J Periodontol 1994

Nov;65(11):1008-1015.

2. Dumitrescu AL. Bone grafts and bone graft substitutes in

periodontal therapy. In: Dumitrescu AL, editor. Chemicals in

surgical periodontal therapy. Berlin Heidelberg: Springer-Verlag

2011. p. 73-144.

3. Nasr HF, Aichelmann-Reidy ME, Yukna RA. Bone and bone

substitutes. Periodontol 2000 1999 Feb;19:74-86.

4. Nairne SP. Nuffield council on bioethics. Animal-to-human

transplants: the ethics of xenotransplantation. London: Nuffield

Council on Bioethics; 1996

5. Hurzeler MB, Quinones CR, Kirsch A, Gloker C, Schupbach P,

Strub JR, Caffesse RG. Maxillary sinus augmentation using

different grafting materials and dental implants in monkeys.

Part I. Evaluation of anorganic bovine-derived bone matrix. Clin

Oral Implants Res 1997 Dec;8(6):476-486.

6. Piattelli M, Favero GA, Scarano A, Orsini G, Piattelli A. Bone

reactions to anorganic bovine bone (Bio-Oss) used in sinus

augmentation procedures: a histologic long-term report of 20

cases in humans. Int J Oral Maxillofac Implants 1999 Nov-

Dec;14(6):835-840.

7. Callan DP, Rohrer MD. Use of bovine-derived hydroxyapatite in

the treatment of edentulous ridge defects: a human clinical and

histologic case report. J Periodontol 1993 Jun;64(6): 575-582.

8. Wenz B, Oesch B, Horst M. Analysis of the risk of transmitting

bovine spongiform encephalopathy through bone grafts derived

from bovine bone. Biomaterials 2001 Jun;22(12):1599-1606.

9. Barash JA, Johnson BT, Gregorio DI. Is Surgery a risk factor for

Creutzfeldt-Jakob disease? Outcome variation by control choice


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-Jou

rnal

IDA

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nch

and exposure assessments. Infect Control Hosp Epidemiol 2008

Mar;29(3):212-218

10. Prusiner SB. Prions. Proc Natl Acad Sci USA 1998

Nov;95(23):13363-13383.

11. Porter SR. Prions and dentistry. JR Soc Med 2002

Apr;95(4):178-181.

12. Porter S, Scully C, Ridgway GL, Bell J. The human

transmissible spongiform encephalopathies (TSEs): implications

for dental practitioners. Br Dent J 2000 Apr;188(8):432-436

13. Azarpazhooh, Leake JL. Prions in dentistry—what are they,

should we be concerned, and what can we do? J Can Dent

Assoc 2006 Feb;72(1):53-60.

14. Li J, Wang HL. Common implant-related advanced bone

grafting complications: classification, etiology, and

management. Implant Dent 2008 Dec;17(4):389-401.

15. Sogal A, Tofe AJ. Risk assessment of bovine spongiform

encephalopathy transmission through bone graft material

derived from bovine bone used for dental applications. J

Periodontol 1999 Sep;70(9):1053-1063.

16. Adams D, Edgar WM. Transmission of agent of Creutzfeldt-

Jakob disease. Br Med J 1978 Apr;1(6118):987.

17. Ingrosso L, Pisani F, Pocchiari M. Transmission of the 263K

scrapie strain by the dental route. J Gen Virol 1999 Nov;80(Pt

11):3043-3047.

18. Ritzhaupt A, Van Der Laan LJ, Salomon DR, Wilson CA. Porcine

endogenous retrovirus infects but does not replicate in

nonhuman primate primary cells and cell lines. J Virol 2002

Nov;76(22):11312-11320.

19. Bach FH, Ivinson AJ. A shrewd and ethical approach to

xenotransplantation. Trends Biotechnol 2002 Mar;20(3):129-31.

20. Todaro GJ, Benveniste RE, Lieber MM, Sherr CJ.

Characterization of a type C virus released from the porcine cell

line PK(15).Virology 1974 Mar;58(1):65-74.

21. Tristem M, Kabat P, Lieberman L, Linde S, Karpas A, Hill F.

Characterization of a novel murine leukemia virus-related

subgroup within mammals. J Virol 1996 Nov;70(11):8241-8246.


L.E.

D. E

-Jou

rnal

IDA

Ludh

iana

Bra

nch

22. Takeuchi Y, Patience C, Magre S, Weiss RA, Banerjee PT, Le

Tissier P, Stoye JP. Host range and interference studies of three

classes of pig endogenous retrovirus. J Virol 1998

Dec;72(12):9986-9991.

23. Wilson CA, Wong S, VanBrocklin M, Federspiel MJ. Extended

analysis of the in vitro tropism of porcine endogenous

retrovirus. J Virol 2000 Jan;74(1):49-56.

24. Oldmixon BA, Wood JC, Ericsson TA, Wilson CA, White- Scharf

ME, Andersson G, Greenstein JL, Schuurman HJ, Patience C.

Porcine endogenous retrovirus transmission characteristics of

an inbred herd of miniature swine. J Virol 2002

Mar;76(6):3045-3048.

25. Denner J. Recombinant porcine endogenous retroviruses (PERV-

A/C): a new risk for xenotransplantation? Arch Virol

2008;153(8):1421-1426.

26. Wilson CA, Wong S, Muller J, Davidson CE, Rose TM, Burd P.

Type C retrovirus released from porcine primary peripheral

blood mononuclear cells infects human cells. J Virol 1998

Apr;72(4):3082-3087.

27. Patience C, Takeuchi Y, Weiss RA. Infection of human cells by

an endogenous retrovirus of pigs. Nat Med 1997 Mar;3(3):276-

282.

28. Akiyoshi DE, Denaro M, Zhu H, Greenstein JL, Banerjee P,

Fishman J. Identification of a full-length cDNA for an

endogenous retrovirus of miniature swine. J Virol 1998

May;72(5):4503-4507.

29. Dobson R. Scientists show that vCJD can be transmitted

through blood. BMJ 2000 Sep;321(7263):721.

30. Armstrong JA, Porterfield JS, De Madrid AT. C-type virus

particles in pig kidney cell lines. J Gen Virol 1971

Feb;10(2):195-198.

31. Denner J. Immunosuppression by retroviruses: implications for

xenotransplantation. Ann N Y Acad Sci 1988 Dec;862:75-86.

32. Weiss RA. Xenografts and retroviruses. Science 1999;285:

1221-1222; US FDA. Transcript from biological response

modifiers committee, xenotransplantation subcommittee. June

3-4 1999. Washington: Millers Reporting Company Inc, 1999.


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33. Pattyn S, Jacob W, van der Groen G, Piot P, Courteille G.

Isolation of Marburg-like virus from a case of haemorrhagic

fever in Zaire. Lancet 1977 Mar;1(8011):573-574.

34. Bowen ETW, Lloyd G, Harris WJ, Platt GS, Baskerville A, Vella

EE. Viral haemorrhagic fever in southern Sudan and northern

Zaire. Preliminary studies on the aetiological agent. Lancet

1977 Mar;1(8011):571-573.

35. Johnson KM, Webb PA, Lange JV, Murphy FA. Isolation and

partial characterisation of a new virus causing haemorrhagic

fever in Zambia. Lancet 1977 Mar;1(8011):569-571.

36. El-Sabban ME, El-Khoury H, Hamdan-Khalil R, Sindet-Pedersen

S, Bazarbachi A. Xenogenic bone matrix extracts induce

osteoblastic differentiation of human bone marrow-derived

mesenchymal stem cells. Regen Med 2007 Jul;2(4):383-390.

37. Li H, Springer M, Zou X, Briest A, Bunger C. Ectopic bone

induction by equine bone protein extract. Adv Exp Med Biol

2006;585:393-402.

38. Sanchez AR, Sheridan PJ, Kupp LI. Is platelet-rich plasma

perfect enhancement factor? A current review. Int J Oral

Maxillofac Implants 2003 Jan-Feb;18(1):93-103.

{Dear Readers: The above article was first published in ‘International Journal

of Implantology and Clinical Research’ Vol. 4 Issue 2 May–August 2013 issue

and has been republished with prior permission from the author Dr. Lanka

Mahesh et al & the Publishing House, Jaypee Journals with due

acknowledgment.}





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Saatwaa Gyaan


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Dr. Rajeev Ranjan graduated from Bharti Vidyapeeth Dental College, Pune in 2008 & did his post graduation in Periodontics from K.L.E. Institute of Dental Sciences, Bangalore in 2013. He is working as a Senior Lecturer in Kalinga Institute of Dental Sciences, Bhubaneshwar since 2013. He has many Original research publications to his credit in National & International Journals. He is apart of many ongoing research activities in his institute; KIDS, Bhubaneshwar. He likes to listen to music, watch movies, read interesting topics both online and in print; in his free time.

Efficacy of 980 nm DIODE LASER as an adjunct to

Stannous Fluoride (SnF2) in the management of

DENTINAL HYPERSENSITIVITY

A controlled prospective clinical study Author: Dr. Rajeev Ranjan

ABSTRACT

Aims and Objectives: The purpose of this prospective clinical

study was to evaluate and compare the clinical effectiveness of

GaAlAs Diode laser alone and with topical 2% Stannous fluoride

gel in the management of Dentinal hypersensitivity.

Materials and Methods Used: 30 patients (14 Males and 16

Females, age 19–70years), contributing 534 teeth with DH were

assessed by air stimuli and measured by Verbal Rating Scale

(VRS). For each patient, the sensitive sites were randomly divided

into G1 (267 teeth), treated by application of 2% Stannous

fluoride gel followed by application of GaAlAs diode laser (Sunny

Germany, 980 nm, 2W, 25 Hz) in continuous mode and G2 (267

teeth), Subjected to only diode laser at the same parameters

employed in G1. VRS recordings were assessed before treatment,

15 min after the laser application and at the end of 2, 7, 14 and

30 days after treatment.

Results: Both Groups have shown significant reduction in DH

after the laser irradiation but reduction in DH was more evident

in GI than G2.

Conclusion: Diode laser is a useful device for DH management

and addition of Stannous fluoride has synergistic effect on laser

desensitization effect.


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KEYWORDS

Diode laser, Dentinal Hypersensitivity, Stannous fluoride gel,

Verbal rating scale

INTRODUCTION

Dentin hypersensitivity (DH) can be described as an adverse

reaction or pain in one or more teeth resulting from either a

thermal, mechanical, or chemical stimulus. Hypersensitive dentin

is an uncommonly sensitive or painful response of exposed dentin

to an irritation. It is one of the most painful, ubiquitous and least

satisfactory treated chronic problems of teeth. Depending on the

population samples studied, 4% to 57% prevalence of DH has

been reported in literature, with higher prevalence of DH ranging

between 60 to 98% in patients suffering from periodontal disease.

Advancement of laser technology and its growing utilization

in dentistry has given an additional therapeutic option for the

treatment of DH. Different types of low (He–Ne, diode) and

middle output power (CO2, Nd:YAG) lasers have been tested for

the reduction of DH but available literature are not sufficient to

give any definitive conclusive remarks. Low output power (low-

level) lasers have shown significant anti-inflammatory effects,

while excessive effects on pulp have been shown by middle output

power lasers.

Diode lasers are the most studied laser in management of DH.

In various studies, different wavelengths of diode lasers have been

used and have shown the best results in several clinical protocols

even in high- grade DH cases.

An additional therapeutic option could be the combination of

laser irradiation with the application of specific products for the

treatment of DH, with the intention of achieving an accumulation

of effects from both treatments. In various clinical studies,

combinations of different types of laser with chemical agents such

as sodium fluoride and stannous fluoride have been evaluated;

with promising results and effectiveness have been found more

than 20% over the laser treatment only.

The aim of the present prospective clinical study was to

evaluate and compare the clinical effectiveness of 980nm Diode


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laser (Fig. 1) alone and in combination with topical Stannous

fluoride (SnF2) gel in the management of DH.

Fig-1: Diode Laser

MATERIALS and METHODS

The patients recruited for this study were selected from the out-

patient division of Department of Periodontics, KLE Society’s

institute of Dental Sciences, Bangalore, Karnataka. Thirty

patients (14 males and 16 females), aged between 19-70 years

(mean age: 41.67 years) with the complaint of DH, contributing

534 teeth were enrolled for the study by convenience sampling

method. Written informed consent was obtained from patients

and it was made clear to the potential subjects that participation

was voluntary. This randomized controlled trial with split mouth

design was carried out from October 2011 to February 2012, with

the follow up of 30 days.

The exclusion criteria for patient enrolment were based on:

carious lesions on the selected or neighbouring teeth, any

desensitizing therapy on the selected teeth during the last 6

months, cervical fillings on the selected teeth, teeth undergone

extensive restoration or endodontic treatment and history of need

to continuously take analgesic medication.


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Phase 1 periodontal therapy in form of Scaling and root

planing followed by Oral hygiene instructions were given to each

and every selected patient and the tooth vitality of all sites was

assessed. The degree of sensitivity to an evaporative stimulus

before and after treatment was determined qualitatively with an

air stimulus (Fig. 2). To check the cold air stimulus, the selected

tooth was isolated, dried and a jet of cold air was applied from a

distance of 1 cm for 1 second (Fig. 3). To avoid any discrepancy

during testing, the dentist’s gloved fingers shielded the

neighboring teeth.

Fig-2: Air Stimulus Application

Fig-3: Isolation & Drying of Teeth


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Patient responses to air stimuli was recorded according to the

Verbal Rating Scale (VRS) scale in four degrees as given by Tarbet

et al and Collins et al.

0: No discomfort, but patient felt stimulus.

1: Slight discomfort, but not painful.

2: Painful during application of stimulus.

3: Painful during application of stimulus and immediately

afterwards.

Air stimulus recordings were assessed before treatment, 15

min after the laser application and at the end of 2, 7, 14 and 30

days after treatment.

For each patient, the sensitive sites were randomly divided into

two groups:

1. Group 1 (G1) (267 teeth) - treated by application of 2%

Stannous fluoride gel followed by application of GaAlAs diode

laser (Sunny Germany, 980 nm, 2W, 25 Hz) in continuous

mode (Fig. 4 and Fig. 5).

2. Group 2 (G2) (267 teeth) – Subjected to diode laser at the

same parameters employed in Group 1.

Fig-4: Fluoride Gel Application


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Fig-5: Diode Laser Application + Stannous Fluoride Gel

Application

In Group 1, 2% Stannous fluoride gel was applied with

cotton pellet and left on tooth surface for 60 seconds before the

irradiation. Application of 980 nm diode laser (2W, 25 Hz,

continuous mode) at three points on the facial surface and at one

point on the lingual surface of incisors and canine and at two

points on the facial and lingual surface of premolars and molars

were performed respectively. Each site received one application

for 30 seconds each at baseline. Laser application was kept

perpendicular to the long axis of the tooth.

In Group 2, teeth were subjected to diode laser irradiation with

the same parameters employed for Group 1 at baseline.

STATISTICAL ANALYSIS

Site prevalence was assessed by Chi square test. Intervisit-

intergroup comparison was done by Mann-Whitney Test and

intervisit-intragroup comparison was done by Kruskal Wallis

Test.


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RESULT

Both Group 1 and Group 2 have shown significant reduction

in DH (Dentine Hypersensitivity) after the diode laser application.

Statistically there was no difference in both groups w. r. t. age

and gender. Site specific reduction in sensitivity estimated by chi

square test showed increased reduction in premolars followed by

incisors, canines and molars (Graph-1).

Graph-1: Site specific reduction in Dentine Hypersensitivity

The mean values of DH in group 1 was 0.96 0.84, 0.80

0.84, 0.72 0.82, 0.73 0.82 and 0.63 0.73, as assessed 15

minutes post-treatment and on days 2, 7, 14 and 30 after the

treatment respectively. In the same way, observed mean values of

DH in group 2 was 1.54 0.81, 1.28 0.81, 1.28 0.81, 1.26

0.81 and 1.29 0.77 at various time intervals post-treatment

respectively. Thus although a decrease in mean values in DH was

observed in both the groups, decrease observed was higher in

Group 1.

Reduction in DH from baseline to at the end of 30 days was

highly significant (P < 0.001) in both group 1 and group 2. When

intergroup comparison of DH between group 1 and group 2 was

done, the value obtained was highly significant (P < 0.001) at

each time interval after intervention.


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Graph-2: Inter-visit Intra-group Comparison

Gr 1 v/s Gr 2

Time Groups N Mean SD Median Minimum Maximum P value *

Significance

Gr 1 267 2.36 0.67 2.0 1 4 Baseline

Gr 2 267 2.18 0.69 2.0 1 3 0.004 S

Gr 1 267 0.96 0.84 1.0 0 3 15min

Gr 2 267 1.54 0.81 2.0 0 3 <

0.001 HS

Gr 1 267 0.80 0.84 1.0 0 3 2day

Gr 2 267 1.28 0.81 1.0 0 3 <

0.001 HS

Gr 1 267 0.72 0.82 1.0 0 3 7 day

Gr 2 267 1.28 0.81 1.0 0 3 <

0.001 HS

Gr 1 267 0.73 0.82 1.0 0 3 14 days

Gr 2 267 1.26 0.81 1.0 0 3 <

0.001 HS

Gr 1 267 0.63 0.73 0.0 0 3 1month

Gr 2 267 1.29 0.77 1.0 0 3 <

0.001 HS

Table 1: Group Wise comparison of DH at each Time interval

Group Time N Mean SD Median Minimum Maximum K-W

ANOVA P value

baseline 267 2.36 0.67 2.0 1 4

15 min 267 0.96 0.84 1.0 0 3

2 days 267 0.80 0.84 1.0 0 3

7 days 267 0.72 0.82 1.0 0 3

14 days 267 0.73 0.82 1.0 0 3

Group 1

1 month 267 0.63 0.73 0.0 0 3

H= 509.5

P< 0.001, HS

Baseline 267 2.18 0.69 2.0 1 3

15 min 267 1.54 0.81 2.0 0 3

2 days 267 1.28 0.81 1.0 0 3

7 days 267 1.28 0.81 1.0 0 3

14 days 267 1.26 0.81 1.0 0 3

Group 2

1 month 267 1.29 0.77 1.0 0 3

H= 230.6

P< 0.001, HS

Table 2: Time interval wise comparison of DH for each group


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DISCUSSION

Studies have shown slightly higher incidence of DH in females

than males, which could be due to be overall oral hygiene &

healthcare awareness in women and is common between the age

group of 20 to 40 years with the peak incidence at the end of

third decades. However in the present study, there was no

statistically significant difference in both groups w. r. t. age and

gender. Interestingly, site specific prevalence showed increased

predilection in premolars followed by incisors, canines and

molars. This was in accordance with the study of Flynn J et al

who also reported the same DH predilection order.

Even though numerous modes of treatments for DH have

been discussed in literature, it is clear that, the ideal treatment

for DH does not exist. This can be true even in case of

combination of different protocols. Traditional methods for the

management of DH comprehend the topical use of desensitizing

agents, either professionally or at home such as protein

precipitants, tubule-occluding agents, tubule sealants, and,

recently, lasers. Various studies describe a synergistic action of

lasers in association with desensitizing agents. It has been noted

that the laser system can favor the permanence of the

desensitizer for longer time than when they are used alone.

Matsumoto et al and Yamaguchi et al have reported

decrease in hypersensitivity by 85% and 60% respectively in teeth

treated with laser. In a double-blind clinical study Gerschman et

al have found significant reduction in treated group in

comparison to the placebo group: sensitivity to thermal stimuli

was reduced by 67%, whereas the placebo group had a reduction

of 17%, sensitivity to tactile stimuli was reduced by 65%, while

the placebo group showed a reduction of 21%. In a systematic

review by Kimaru et al on management of DH by laser has

concluded GaAlAs laser of wavelength 800 nm has 30%-100%

and GaAlAs laser of wavelength 900nm has 73.3%-100%

effectiveness in management of DH.

Better results were obtained by combined intervention of

laser and stannous fluoride (SnF2) gel therapy (G1) in

management of DH in the current study. It is possible that the


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better performance of combined treatment was due to the higher

stannous fluoride gel adhesion to the dentinal tubules when

combined with laser energy. Even in consideration of the short

sample analyzed, it is possible to speculate that the laser-induced

superficial melting permits longer tubules occlusion by stannous

fluoride gel emphasizing the reduction of DH-related pain.

There was also a significant reduction in sensitivity at 15

minutes followed by further reduction at 2,7,14 and 30 days post-

treatment. These findings were in accordance with Lin and Lan

who reported that the combined use of the GaAlAs laser (830 nm

wavelength) with fluoridation enhances treatment effectiveness by

more than 20% over that of laser treatment only. The added

advantages of combination of dental laser with stannous fluoride

has been reported in another in vivo study by Moritz et al and

suggested that the combined laser treatment and fluoridation

result in permanent integration of fluoride on the dentinal

tubules. The present clinical study has shown that, addition of

fluoride with laser had more significant reduction and reduction

was seen immediately after 15 min. Inter visit comparison shows

greater change on day 30 with mean value 0.63 in group 1 and

1.29 in group 2. This result might be due to the synergistic effect

of fluoride when used along with the diode laser.

CONCLUSION

1. Dentin Hypersensitivity is an age old problem. Plethoras

of treatment modalities are available amongst which

laser seems to be more effective, and has rapid and

lasting effect.

2. When satisfactory oral hygiene is maintained laser plays

vital role in reduction of sensitivity which is common

problem to patient and dentist and causes crippling

discomfort.

3. Addition of fluoride has synergistic effect on laser

desensitization.


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REFERENCES

1. Collins JF, Gingold J, Stanley H, Simring M. Reducing dentinal

hypersensitivity with strontium chloride and potassium

nitrate. General Dentistry 1984; 32: 40–43.

2. Grossman LI. A systematic method for the treatment of

hypersensitive dentin. Journal of American Dental Association

1934; 22: 592–602.

3. Rees J.S, Addy M. A cross-sectional study of dentine

hypersensitivity. Journal of Clinical Periodontology 2002; 29:

997–1003.

4. M. B. Chabanski, D. G. Gillam, J. S. Bulman, and H. N.

Newman. The prevalence, distribution and severity of cervical

dentine sensitivity (CDS) in a population of patients referred to

a specialist periodontology department. Journal of Clinical

Periodontology 1996; 23: 989–992.

5. Renton-Harper P. & Midda M. NdYAG laser treatment of

dentinal hypersensitivity. British Dental Journal 1992; 172:

13–16.

6. Zhang C., Matsumoto K., Kimura, Y., Harashima T., Takeda F.

H., Zhou H. Effects of CO2 laser in treatment of cervical

dentinal hypersensitivity. Journal of Endodontics 1998; 24:

595–597.

7. Kimura Y., Wilder-Smith P., Yonaga K.,Matsumoto K.

Treatment of dentine hypersensitivity by lasers: a review.

Journal of Clinical Periodontology 2000; 27: 715–721.

8. Zanirato R., Curti F., Prezzotto G., De Carvalho E., Pelizon J.

E., Bagnato V. S. Clinical effects of low-intensity laser vs light-

emitting diode therapy on dentin hypersensitivity. Journal of

Oral Laser Applications 2007; 7: 129–136.

9. Launay Y., Mordon S., Cornil A., Brunetaud J. M., Moschetto,

Y. Thermal effects of lasers on dental tissues. Lasers in

Surgery and Medicine 1987; 7: 473–477.

10. Matsumoto K, Tomonari H, Wakabayashi H. Study on the

treatment of hypersensitive dentine by laser. J Conservat Dent

1985; 28: 1366-1371.


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-Jou

rnal

IDA

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iana

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11. Yamaguchi M, Ito M, Miwata T, Horiba N, Matsumoto T,

Nakamura H, Fukaya M. Clinical study on the treatment of

hypersensitive dentin by GaAlAs laser diode using the double

blind test. Aichi-Gakuin J Dent Sci 1990; 28: 703-707.

12. Gerschman JA, Ruben J, Gebart-Eaglemont J. Low level laser

therapy for dentinal tooth hypersensitivity. Aust Dent J 1994;

39: 353-357.

13. Kumar N. G. & Mehta D. S. Short-term assessment of the

Nd:YAG laser with and without sodium fluoride varnish in the

treatment of dentin hypersensitivity – a clinical and scanning

electron microscopy study. Journal of Periodontology 2005;

76:1140–1147.

14. Goharkhay K., Wernisch J., Schoop U., Moritz A. Laser

treatment of hypersensitive dentin: comparative ESEM

investigations. Journal of Oral Laser Applications 2007; 7:

211–223.

15. Tarbet W. J., Silverman, G., Stolman J. M., Fratarcangelo P. A.

Clinical evaluation of a new treatment for dentinal

hypersensitivity . Journal of Periodontology 1980; 51: 535–

540.

16. Collins J. F., Gingold J., Stanley H., Simring, M. Reducing

dentinal hypersensitivity with strontium chloride and

potassium nitrate. General Dentistry 1984; 32:40–43.

17. Flynn J, Galloway R, Orchardson R. The incidence of

hypersensitive teeth in the west of Scotland. J Dent 1985; 13:

230-236.

18. Graf H, Galasse R. Morbidity, prevalence and intraoral

distribution of hypersensitive teeth. J Dent Res 1977; 56 (Spec

Issue A) 162, abstr 479.

19. Kerns D.G, Scheidt M.J, Pashley D.H, Horner J.A, Strong

S.L, Van Dyke T.E. Dentinal tubule occlusion and root

hypersensitivity. Journal of Periodontology 1991; 62: 421–428.

20. Wichgers T.G, Emert R.L. Dentin hypersensitivity. General

Dentistry 1996; 44: 225–232.

21. Lan W.H, Liu H.C, Lin C.P. The combined occluding effect of

sodium fluoride varnish and Nd:YAG laser irradiation on


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human dentinal tubules. Journal of Endodontics 1999; 25:

424–426.

22. Moritz A, Gutknecht N, Schoop U, Goharkhay K, Ebrahim D,

Wernisch J et al. The advantage of CO2-treated dental necks,

in comparison with a standard method: results of an in vivo

study. J Clin Laser Med Surg. 1996; 14 :27-32.

{Dear Readers: The above article was first published in ‘Journal of Dental

Lasers’ Vol. 7 Issue 2 (2013) issue and has been republished with prior

permission from the author Dr. Rajeev Ranjan & the Publishing House,

Wolters Kluwer – Medknow Publication with due acknowledgment.}





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Aathwaa Gyaan


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Dr. Meenu Bhola has passed her BDS from Govt. Dental College, Amritsar and finished her Post Graduation in Pediatric and Preventive Dentistry from Christian Dental College, Ludhiana. She has many national and international publications to her credit. She has presented many scientific papers in various conferences. Currently, she is working as Professor at DIRDS, Faridkot and practicing as Pediatric dentist at Ludhiana. Dr. Geetika Jindal has passed her BDS from Guru Nanak Dev Dental College and Research Institute, Sunam and finished her Post Graduation in Pediatric and Preventive Dentistry from DIRDS, Faridkot. She has many national publications to her credit. She has presented many scientific papers in various conferences. Currently, she is working as a Senior Lecturer at DIRDS, Faridkot. Dr. Aashana Goel has passed her BDS from DIRDS, Faridkot and is pursuing her Post Graduation in Pediatric and Preventive Dentistry from DIRDS, Faridkot. She has presented scientific papers and posters in various conferences. Currently, she is a Post Graduate student at DIRDS, Faridkot.

RADIX ENTOMOLARIS in PERMANENT

MANDIBULAR FIRST MOLAR

An Endodontic Challenge?

A Case Report

Author: Dr. Meenu Bhola

Co-Author 1: Dr. Geetika Jindal

Co-Author 2: Dr. Aashana Goel

ABSTRACT

Comprehensive knowledge of the root canal anatomy is a basic

pre-requisite for endodontic treatment. The success of endodontic

treatment depends upon the proper identification of all canals,

thorough chemo-mechanical preparation followed by a three-

dimensional obturation with a hermetic seal. The endodontic

treatment of a mandibular molar with an aberrant canal

configuration (anatomy) can be diagnostically and technically

challenging.

Radix Entomolaris is one such aberration where an extra

root is usually present on the disto-lingual aspect of mandibular

first molar. This article presents a case report of mandibular first

molar with extra root which was successfully treated.


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KEYWORDS

Endodontic Treatment, Mandibular First Molar, Radix

Entomolaris.

INTRODUCTION

The American Association of Endodontics (AAE) has defined root

canal obturation as “the three dimensional filling of the entire root

canal system as close to the cemento-dentinal junction as

possible”. A tight apical seal is considered desirable to prevent

remaining bacteria and their endotoxins from invading the apex.

The main objective of the root canal treatment is thorough

mechanical and chemical cleaning of all the canals before the

obturation with an inert filling material. Thus, the treatment of

the entire root canal system is essential to maximize the

possibility of obtaining success in endodontic therapy. For this

purpose, knowledge about the anatomy of the pulp chamber and

root canal system along with its potential variations are an

indispensable part of endodontics. It is very well known that

mandibular first molar may display several anatomical variations

in its configuration. Most mandibular first and second molars in

Caucasians have roots with two mesial canals and one distal

canal. Presence of a third root in the permanent first molar is the

major variant of this group.

An additional root, firstly mentioned in literature by

Carabelli in year 1844 is called Radix Entomolaris. The presence

of extra root on lingual side of mandibular first molar is Radix

Entomolaris. Apart from mandibular first molars, it may be rarely

found in mandibular third molars but has not been reported in

mandibular second molar yet. The other variant is Radix

Paramolaris which indicate presence of extra root on the buccal

side.

This case report highlights Radix Entomolaris, a developmental

variation occurring in mandibular molar which is associated with

an extra lingual root, its diagnosis and the endodontic

management.


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CASE REPORT

HISTORY & CHIEF COMPLAINT

A 14 year old female patient named Ramandeep Kaur, reported to

Department of Pedodontics and Preventive dentistry, Faridkot

with chief compliant of severe pain in the right lower back tooth

region since one month. Pain was of intermittent type, aggravated

on taking cold and hot food and persisted even after the removal

of stimulus. No other significant medical history was recorded.


A diagnostic radiograph was taken which revealed deep caries

with pulpal involvement associated with periapical changes like

widening of periodontal ligament space around the apical area.

On keen observation, there appeared to be an additional root.

Another radiograph was taken which confirmed the presence of

extra root on distolingual side (Fig. 1).

Fig-1: Diagnostic periapical radiograph showing additional

root using the SLOB rule

DIAGNOSIS and TREATMENT PLAN

So, the patient was diagnosed with acute apical periodontitis after

thorough clinical and radiographic examination. Patient was told

to get the pulpectomy of the tooth done.


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TREATMENT PROTOCOL FOLLOWED

1. Tooth was isolated using rubber dam.

2. Root canal treatment was initiated after administering local

anaesthesia.

3. Access preparation was done using an Endo access bur.

4. Careful exploration of the pulp chamber floor of access cavity

using endodontic explorer revealed two distal canal orifices

and two mesial canal orifices.

5. There was a modification done in the access cavity

preparation from triangular shape to trapezoidal form.

Fig-2: Working Length Radiograph w.r.t. 46

6. Patency of canals was made with 15 K-file (Mani Japan).

7. Working length was determined radiographically (Fig. 2).

8. Cleaning and shaping was done with rotary ProTaper

instruments in a step-back manner.

9. EDTA was used as a lubricant and alternate irrigation with

sodium hypochlorite and normal saline was done.

10. Master Cone Working Length X-Ray was recorded (Fig. 3) and

Obturation was performed with gutta percha using lateral

condensation technique (Fig. 4 & Fig. 5).

11. Access cavity was restored with light cure GIC and a post-

obturation radiograph was taken.


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Fig-3: Master Cone Radiograph w.r.t. 46

Fig-4: Post Obturation Radiograph w.r.t. 46

Fig-5: Post Obturation Radiograph w.r.t. 46 (Another Angle)


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DISCUSSION

A thorough knowledge of root canal morphology and configuration

of teeth plays an important role in the success of endodontic

therapy. The prevalence of Radix Entomolaris in mandibular first

molar has been well documented in literature. It is associated

with various ethnical groups with the highest frequency (5%-30%)

being observed in population with Mongoloid trait such as

Chinese, Eskimos and American Indians. In African populations,

it is around 3% with least occurrence among Indians (0.2%). A

bilateral occurrence in the population ranges from 50%-67%.

The etiology behind the formation of Radix Entomolaris is

still uncertain. It can be related to certain external factors during

odontogenesis or the penetration of the atavic/atopic gene or a

polygenic system. Third root anomalies may develop during bud

morpho-differentiation as a result of the developmental aberration

of both ectoderm and mesoderm. Curzon suggested that three-

rooted molar trait has a high degree of genetic penetrance

(penetration).

A classification was given by Carlsen & Andersen based on

the location of the cervical part. They are types A, B, C, AC.

a. Type A & Type B refers to a distally located cervical part.

b. Type C refers to a mesially located cervical part.

c. Type AC refers to the location of the cervical part in the

central location in between the mesial and distal components.

De Moor et al had given other classification based on the

curvature of Radix Entomolaris variants in the bucco-lingual

direction.

a. Type I which refers to straight root / canals

b. Type II refers to a curvature at the entrance of the orifice

c. Type III refers to Radix Entomolaris with two curvatures, one

at the coronal level and the other at the middle third.

Once a diagnosis of additional root is reached and an

access cavity has to be prepared, care should be taken to


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establish a “straight-line” access. With the disto-lingually located

orifice of the Root Canal, a modification of the classical triangular

access cavity to a trapezoidal form is required to locate and

access the root canal. The laws of orifice location may aid in the

location of extra orifices. Diagnostic measures such as multiple,

pre-operative radiographs, examination of the pulp chamber floor

with a sharp explorer, troughing of the grooves with ultrasonic

tips, staining the chamber floor with 1% methylene blue dye,

performing the sodium hypochlorite “champagne bubble test,”

and visualizing canal bleeding points are all important aids in

location of the root canal orifices. An endodontic explorer can be

used as a pathfinder to determine the angle at which the canals

depart from the main chamber. Other advanced diagnostic aids

may also help in the better identification and visualization of all

the canals.

Some of the most common problems encountered during

the treatment of Radix Entomolaris are:

1. Difficulty in Radiographic interpretation.

2. Inability to locate the fourth canal.

3. Modification in access cavity preparation.

4. Confusion in working length determination.

Apart from these difficulties, clinicians are prone to

commit some iatrogenic errors like straightening of a root canal

resulting in loss of working length, ledge formation, zipping,

transportation or even perforation.

CONCLUSION

The prognosis of the root canal treatment depends upon the

careful observation and interpretation of radiographs to avoid

missing any extra canals. A number of variations can occur which

might pose a challenge to the clinician. This particular variation

Radix Entomolaris may be a challenge to those who don’t have

proper diagnostic aids and lack in proper knowledge of root canal

anatomy. Hence, knowledge about the unusual root canal

morphologies in terms of root inclination and root canal

curvatures among various ethnical groups is important.


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REFERENCES

1. Balasubramanian, A, Bhosale, S, Kumar3, MR, Jayasree , S

(2013), Endodontic Management of a Tooth with Radix

Entomolaris and Five Root Canal’, Journal of Dental and

Medical Sciences, vol.10, issue.6, pp. 62-65.

2. Bolla, N, Naik, B, Kavuri, SR, Sriram, SK, Radix Entomolaris: A

Case Report, Endodontology.

3. Das, M, Sethi, P, Kavitha, Singh, A (2015), The radix

Entomolaris in permanent Mandibular first molar- An

Endodontic Challenge’, International Journal of Advanced

Multidisciplinary Research, vol.2, issue.5, pg 44-49.

4. Davini, F, Cunha RS, Fontana, ES, Silveira, CF, Silveira Bueno,

CF (2012), Radix entomolaris – A case report’, RSBO, vol. 9,

issue. 3, pg. 340-4.

5. Hegde, V, Kashid, V (2015), Radix Entomolaris-Series Of Case

Reports’, International Journal Of Advances, vol.2, issue.4, pp.

216-220.

6. George, R, Kavyashree, G (2015), Endodontic Management of

Radix Entomolaris’, Journal of Dental and Medical Sciences,

vol.14, issue. 12, pp. 12-14.

7. Kamath, U, Sheth, H, Mohan, N, Reddy, D (2015), Endodontic

management of radix entomolaris: Case reports, International

Journal of Applied Dental Sciences, vol. 2, issue. 1, pp. 15-19.

8. Mahalakshmi, S, Shenoy MA, Shubha, B, Chandy, CJ (2014),

Radix Entomolaris – a rare case series’, SADJ, vol. 69, no. 8.

9. Pai, AR, Jain, R, Colaco, AS (2016), Detection and endodontic

management of radix entomolaris: Report of case series’, Saudi

Endodontic Journal, vol. 4, Issue. 2, pp. 77-82.





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Nauwaa Gyaan


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Dr. Parminder Singh Grover is a graduate of 2002 from Himachal Dental College, Sundernagar (H.P.). He started his own clinical practice in 2003. Presently, he is a Consultant at SPS, Apollo Hospital Ludhiana and currently runs his practice in two different operatories in Ludhiana.

Dr. Supreet Kapoor is a dentist from Ludhiana, and is a graduate from Christian Dental College Ludhiana. Currently, she is practicing with Dr. Parminder Singh Grover at his clinic in Ludhiana.

NANODENTISTRY

A Novel Approach

Author: Dr. Parminder Singh Grover

Co-Author: Dr. Supreet Kapoor

INTRODUCTION

Nanotechnology, a term though new in surroundings but yet has

its root long back which lies when the concept was first given by

late Nobel physicist Richard P. Feynman - “plenty of room at the

bottom”.

This idea though not accepted at that time but was later taken

forward by Eric Drexler who introduced this term, henceforth

making better materials with much better properties.

As per Norio Tsaniguchi - Nanotechnology mainly consists of

processing, separation, integration and deformation of materials

at atomic level, furthermore integration of above concept into

dentistry thus making upgradation of oral hygiene leads to

emergence of new term – Nanodentistry.

This branch mainly involves concepts of nanotechnology which in

general is understood by following 4 approaches:

1. Bottom-up Approach

2. Top down Approach

3. Functional Approach

4. Biomimetic Approach


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a. Bottom-up Approach: This approach mainly involves a

smaller to bigger complex making entity, the bonds of

resultant being extremely strong. This approach has its

influence in dentistry as follows:

1. Nano-anesthesia: This technique involves use of active,

analgesic micrometer dental nano-robots which within

100 seconds reaches pulp through dentinal tubules all

under control of nano-robot .This solution is available in a

colloidal suspension for local anesthesia.

2. Hypersensitivity cure: This being a newer concept involves

occlusion of selected dentinal tubules by reconstructive

dental nano-robots thus making cure for hypersensitivity.

3. Denti-frobots: This is a concept involving nano-robotic

dentifrice delivered by mouth washes etc. These denti-

frobots through metabolization debride calculus and

further destroying pathogenic bacteria giving rise to

healthy oral ecosystem.

4. Cancer diagnosis: A less invasive means of identifying

cancer cells through identification and quantification of

cancer markers is provided through nanotechnology .This

involves use of Physiochemical nanoscale modification

through the following:

i. Nano-texturing

ii. Quantum dots

iii. Bio barcode assay

iv. Nanometer scale tubes and wire

v. Nanoelectromecahnical systems

vi. Therapeutic nanotechnology

This approach makes use of localize delivery of multiple

and complimentary therapeutic agents. They possess site

specific targeting ability thus making more effective use of

drugs .


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5. Dental durability and cosmetics: Fracture resistant nano-

structured composite nano-material including nano-tubes

are being used for upper layer enamel replacement in

cosmetic dentistry.

6. Orthodontic nano-robots: Nano-robots because of high

positional accuracy can complete the desired action and

then can be easily removed by human excretory channels.

These orthodontic nano-robots can manipulate structures

surrounding tooth like periodontal ligament, alveolar bone

etc thus allowing rapid painless tooth movement.

b. Top down Approach: It seeks to produce smaller devices, as

the name suggest, from bigger ones with precision in

structure. It mainly involves:

1. Nanotechnology for composite: It involves idea to improve

the properties of composite material in terms of

polymerization shrinkage, wear resistance etc.

2. Glass Ionomer Cement: It mainly involves formulation of

cement based on bonded filler with high fluoride release, it

also has shown ability to create caries inhibition zone after

acid exposure because of integration with nanomaterial.

3. Improving Endodontics: By the concept of N.E.R.P. -

Nanomaterial enhanced retrofiller polymer - with the

advantage of better strength and adaptability. These

materials were significantly found to reduce the

microleakage of bacteria compared to conventional

materials thus demonstrating their sealing ability.

4. Impression material: These materials are integrated with

nano-fillers thus making better flow along with improved

properties such as tear strength.

5. Nano-titanium implants: They are highly compatible with

20 times faster bonding and improved strength.


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6. Other techniques involve nano-needles and nano-tweezers

and biodegradable nano-fillers.

c. Functional Approach: It involves development of components

of desired functionality without regard of how they are

assembled. E.g. Synthetic chemical methods used to create

synthetic molecular motors.

d. Biomimetic Approach: A system of imitation of models and

systems for purpose of solving complex human problem. In

other words, the use of concepts to create newer materials.

There is use of this approach at micro-molecular level –

NANO-BIOMIMETICS

Though four approaches are in use, the maximum output in

dentistry is through first two.

Various Nano-materials and Devices:

1. Nanopores

2. Quantum dots

3. Nanoshells

4. Dendromers

5. Liposomes

6. Nanorods

7. Fullerene

NANO-ROBOTS in GENERAL

It is the creation of robots at microscopic scale of nanometers (0.5

- 3 micrometer in diameter) with main element as carbon with

increased strength and chemical inertness.

ELEMENTS of NANO-ROBOTS

The bulk of it is carbon in form of diamond or fullerene. Though it

is much in acceptance and is an emerging field, this technique

still involves many challenges viz. below:

1. Biocompatibility

2. Precision


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3. Coordination of activities

4. Economical status

5. Social issue of acceptance

6. Though with above issues risk posed by molecular

manufacturing and social risk need further investigation

SCOPE of NANOTECHNOLOGY

This is now the third highest booming field with a new scope in

upcoming generations but India is still in the development stage

for nanotechnology.Though research labs are doing excellent jobs

but it may still take a few years to settle as an established field.

CONCLUSION

Mutidisciplinary approach of nanotechnology offers great

potential in dentistry ranging from our restorative materials to

implants. Though it opens a huge range still a need to critically

examine its risk and potential toxicity lies at par.

REFERENCES

1. Sneha sundar rajan shashmi rashmi and vidya saraswath

2. Gribbin and gribbin 1997

3. Das etal

4. Freitas robot 2000

5. Shetty etal 2013

6. Uysal etal

7. Chogle etal

8. Kumar and vijaylakshmi 006

9. Albrektssonet al 2008

10. Gaurav chaudhary tarun Sharma tarun rana





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Daswaa Gyaan


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Dr. Bhavdeep Singh Ahuja is a Dentist in Ludhiana, Punjab, having graduated in 1998 from Punjabi University, Patiala. He has specialized in Implants from BioHorizons Inc. USA in 2004-05 & in an Advanced Course from LACE-ICOI, USA in 2006. Apart from Dentistry, he holds a Triple M.B.A. in Hospital Management, Human Resource Management & Marketing from three premier Institutes /Universities of India viz. the IIMM Pune, IGNOU New Delhi & Annamalai University. He holds Post Graduate Diploma’s in various specialties viz. Medical Law & Ethics (NLSIU), Clinical Research, Cyber Law, Disaster Management, Financial Management, Bioinformatics amongst many more from different Universities. He is a Certified Health Care Waste Manager from IGNOU & is qualified in Consumer Law as well. He is an academically oriented dentist & has many Original Scientific Publications to his credit in many International & National journals. Presently, he is into 17th year of Clinical Practice in Ludhiana, Punjab & is reachable on www.drbhavdeep.com

Managing Better – An Art & a Science – XI

A few Rules – None too Many

Author: Dr. Bhavdeep Singh Ahuja

Continued from Vol. 1 Issue 10 22. Rule 22: Follow marketing strategies which are time

tested and which never fail

No matter what we do, where we operate from or what

we offer our patients, for any business, ensuring that we have

a relevant and stable marketing strategy is crucial. Not only

will it keep us actively in the limelight of our sector, it will

make sure we attract as many people as possible to our

practices online. Regardless of the any type of professional

business or services we offer, there are a few time tested and

solid marketing strategies which usually never fail and are

critical in creating a fruitful venture and we becoming a

successful entrepreneur. There is nothing wrong with creating

an environment of anticipation, but the experience better pay

off. There are a few golden rules or marketing strategies which

we have to bear in mind when approaching the marketing of

our business and we should make sure we follow them to

optimize our marketing needs because these will help us

create a stronger brand and attract more patients to our

practice. However, a word of caution, as these are only the

basics and offer an introduction to creating a solid marketing


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structure; the rest is down to dedicated and consistent work.

Here are a few of them:

a. What is/are your USP (Unique Selling Proposition);

highlight it (the uniqueness). Having a practice already set

up, we should be well aware of what our USP is/are (can be

more than one also). Without any of the above, many

practices eventually fall at the first hurdle, as they simply

can’t offer new patients something an established

practice/clinic can. Keep this in mind and make sure we

mention what makes us different as much as we can,

where we Professionals especially doctors/dentists in

private practice (particularly the medium ones) often

struggle to find something different to say about our

services. We only talk about what we do; so what makes

our services unique compared to our competitors? Rather

than what we offer, we have to think about the way (how)

we offer it, and how this benefits our patients. We might

have a special way of attending to our patients for

assessing their problems and troubles. Once we start

focusing on this, we would have created our unique selling

proposition (USP).

b. Keep it Fresh: Even though it is unlikely that what our

intentions as a practice are and what we offer to change,

keep the marketing fresh. Update your website with good

intelligent content whenever possible, keep an active

presence on social media sites and let people know you are

a living breathing existent individual. Appearing interested,

and not leaving old messages or posts to go stale will show

the patients that we have a passion to provide, not to

mention, it will encourage them to want to connect with us

on a more personal level.

c. Stay Connected: Hand in hand with keeping your

marketing fresh is staying connected. Posting regularly on

Facebook or Twitter is all but pointless if we aren’t willing

to put the effort into what comes next – the contact.


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Patients will feel connected and respected if they comment

on a post, for example, and receive a reply.

d. Standardization: Consistency is crucial, we can’t expect

others to be okay when they expect a connection to happen

but no one was there to reply to them, like they were for

others. We have to be consistent and once we have worked

out our USP, we have to apply it to everything with the new

uniqueness. Shun off the old issues as the ghosts of the

past can rise from closet any day. New prospective patients

can come to you from all kinds of routes viz. business

cards, website, phone call, newsletters, blogs, print or

online ads and so on. If we are not consistent in our

uniqueness, we may run the risk of confusing our patients

with mixed messages. We can engage and then only hope

to reap the awards.

e. KISS: Follow the KISS principle; keep it sweet and simple

while writing Editorials or Blogs. Don’t over-complicate the

working style. We may understand the intricate workings of

our services, but may not be entirely relevant, useful or

interesting to our patients. Potential patients are more

inclined to read the ads or marketing blog if it is simple, to

the point and straightforward. Wordy explanations and

flowery writing loses its attention before we can actually get

our point across. Whatever, we need to pass on, should be

done in a creative, yet concise manner.

f. Branding: When branding our practices, create a look that

is different from the others which forms the basis of the

web design or logo which helps us ensure standing out

from the competition.

g. Stay away from fake information: Build the brand from a

position of truth (not hype) and keeping it real is the first

step. Usually, patients can spot hype from far off, so it is

always better to offer them real content, real benefits with

real value for money. We have to demonstrate our ability to


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do this through case studies and testimonials. Don’t offer

the moon, if you can't operate a space ship.

h. Know your Key words: Search Engine Optimization (SEO) is

a way to learn the secrets of using keywords to get the

clinic and services listed higher on search engine listings. If

we know, how to use keywords to generate more hits on

our blog or website, it will bring in the patients who need

what we have to offer.

i. Blogs: Create a blog and write about your offerings and

services in a new and an engaging way. This can be linked

to your clinic website and learn how to blog effectively to

bring in more hits and to get more business. Advertising on

your blog also opens the doors to more cash flow options.

j. Learn how marketing is constantly evolving: Online

marketing is always changing and developing and it’s a

keep up or get left behind situation. Keep up to date with

changes to social media sites, SEO, blogger platforms and

occasionally check marketing blogs for fresh information. It

can actually surprise us that it is easy to pick up and

execute the knowledge and is priceless keeping us ahead of

the competition with the information base we already have.

k. Promise only what you can deliver, keeping it truthful:

Patients know what they want, when and how they want it

usually before they even come onto our website. This

means we need to be fully prepared for anything they may

have queries on beforehand. Offering FAQ’s on the website,

customer reviews and links to social media profiles always

helps a great deal showing that we care about patients and

the services they receive. Patient service should start the

second they click onto your website, not just on the

appointment date. A big mistake is to try to boost the

online appearance by tweaking or essentially lying about

things. Don’t say what you can’t deliver on a promise. If

some materials or components (like Implants) have to be


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outsourced, don’t tell the patient, it will be there in 2 days.

Do not make up customer reviews and never use services

like pay for likes or queue jumping to bump up the website.

Online users are extremely good at sniffing out rats, and a

rat is not something we want to be when trying to run a

successful, healthy and developing clinical practice.

(To be Continued)

REFERENCES

1. Phillip Kotler, Gary Armstrong, John Saunders, Veronica

Wrong et al. Principles of Marketing, 2nd European Edition

2. Phillip Kotler, Kevin Lane Keller et al. Marketing

Management, Twelfth Edition

3. Laura Lowell; 42 rules of marketing

4. The Expert Guide to Affiliate Marketing;

http://Rags2RichesSystem.biz

5. http://www.beckershospitalreview.com/hospital-

management-administration/

6. http://www.ducttapemarketing.com/

7. http://www.bloomberg.com/visual-data/best-

andworst/most-efficient-health-care-2014-countries

8. http://www.forbes.com/

9. https://www.qualitylogoproducts.com/blog/

10. http://www.macquarie.com/

11. http://marketingland.com/

12. http://www.inc.com/

13. http://www.brandfactory.com.au/

14. http://www.brandfactory.com.au/

15. https://www.entrepreneur.com

16. http://www.cision.com/

17. http://www.managementhelp.org/

18. Wikipedia; https://en.wikipedia.org/wiki/


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As all good things come to an end one day, Dr. Bhavdeep Singh

Ahuja, the Editor-in-Chief of L.E.D. E-Journal will wind up this

series of articles on ‘Managing Better – An Art & a Science’ next

month with his last article in December 2016 in L.E.D. E-

Journal.


The above article by Dr. Bhavdeep S. Ahuja will be published in XII parts.

The above is Part XI.

Check out L.E.D. Issue Jan. 2016 Vol. 1 Issue 1, Feb. 2016 Vol. 1 Issue 2,

Mar. 2016 Vol. 1 Issue 3, Apr. 2016 Vol. 1 Issue 4, May 2016 Vol. 1 Issue 5,

June 2016 Vol. 1 Issue 6, July 2016 Vol. 1 Issue 7, August 2016 Vol. 1 Issue

8 , September 2016 Vol. 1 Issue 9 & October 2016 Vol. 1 Issue 10 for the Ist,

IInd, IIIrd, IVth, Vth, VIth, VIIth, VIIIth , IXth & Xth parts of the above article.

Check out L.E.D. Issue December 2016 Vol. 1 Issue 12 for the XIIth and the

LAST part of the above article in this series.





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HAPPY CHILDREN’s DAY


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for

Your honest opinion is of immense value to us. For encouraging the

same, we are starting an award for ‘Best Feedback Series’ every

month. Send your feedback to the Editor in-Chief, Dr. Bhavdeep

Singh Ahuja’s email at [email protected] regarding what is

your overall opinion on E-Journal L.E.D. (Let’s Enjoy Dentistry) or on

the current issue or any particular section of it. The feedback can be

like a performance appraisal, critique review, criticism, applause,

appreciation etc. In short both, bouquets and brickbats are welcome

in equal measure by us. We would be happy to publish with due

credits (both critique review and admiration), the award winning

feedbacks in the next issue of the Publication. However, if the

Branch Member wishes to keep his/her identity secret/hidden, the

feedback would be published under the heading Anonymous. The

best feedback (every month) stands to win a surprise gift at the next

CDE/GBM of IDA Ludhiana Branch. So, if you want to win a prize,

get going, type out your honest feedback and send it to the Editor-in-

Chief, Dr. Bhavdeep Singh Ahuja’s email at [email protected].


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L.E.D. E-Journal

Manuscripts Invited

Would you like to publish in the most happening IDA Local

Branch (IDA Ludhiana) official publication, ‘L.E.D.’ – ‘Let’s

Enjoy Dentistry’, a monthly E-Journal with 11 scientific

articles every month (the first for any local branch dental

journal; both the frequency and the number of articles) in the

ratio of 8 National/International Authors, 2 Local (Ludhiana)

Authors & 1 by the Editor-in-Chief apart from the Editorial.

The first 6 month slots are already gone and out of the 66

articles by 71 authors in the first 6 months since January

2016 launch, even a single Author has not been repeated yet

(again a first) except for the articles in split parts or articles in

series. LED Ludhiana requests original submissions about any

aspect of dentistry in the broadest sense, including, limited

not only to teeth but all aspects of oral health. LED is an

open-access, peer-reviewed journal focused on enlightenment

with enjoyment, but what makes LED truly unique is that it is

multi-disciplinary in scope, publishing articles from all

including young budding authors and is exclusively outreach

oriented. Do you have an interesting case presentation,

research/ review article or a short communication? If so, then

LED could be your perfect outlet. LED could be the

quintessential journal for disseminating your information to a

broad audience that increasingly relies on the Internet for

information. So, what are you waiting for, pick up your pen or

keyboard, punch in & send it across to the Editor-in-Chief, Dr.

Bhavdeep Singh Ahuja at [email protected]. This is

your ticket to ‘Hall of Fame’; the author guidelines are already

attached along with. If you wish to discuss a potential

manuscript idea, please contact the Editor-in-Chief, Dr.

Bhavdeep Singh Ahuja at [email protected] or at his

phone no. 98761-93039.

We look forward to receiving your next manuscript.


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E-Journal

1. Author Guidelines

2. Dental Council of India – Revised Code of Ethics

3. Dental Council of India – Right to Information - Handbook

4. Dental Council of India – Notification – Establishment

Scheme for Opening of New Dental Colleges

5. WHO – Guidelines for Dengue & Chikungunya

6. Dental Trauma Guidelines (Revised) – International

Association of Dental Traumatology

7. Govt. of India Gazette Notification - Revised Bio Medical

Waste Management Rules 2016

8. Atomic Energy Regulatory Board (AERB) – Introduction &

Guidelines for Starting a Diagnostic Installation

9. Atomic Energy Regulatory Board (AERB) – Revised

Guidelines for obtaining Regulatory Consents for

Diagnostic Equipment

10. Atomic Energy Regulatory Board (AERB) – Guidelines for

shielding of X-ray Installations

11. Atomic Energy Regulatory Board (AERB) – Guidelines for

applying for License Diagnostic Radiology Equipment

12. Atomic Energy Regulatory Board (AERB) – Checklist for

submission of application form for registration

13. National Treatment Guidelines for Antimicrobial Use in

Infectious diseases

14. Central Drugs Standard Control Organization – Frequently

Asked Questions on ‘Registration and Import of Medical

Devices in India’

* New from this Issue


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L.E.D. E-Journal November 2016 Vol. 1 Issue 11

APPENDICES Index

S. No.

Title Details Page No. From – To

1. Author Guidelines For Publishing 150 – 154 2. DCI - Revised Code of

Ethics Dental Council of

India 155 – 165

3. DCI – Right to Information - Handbook


166 – 191

4. DCI – Establishment Scheme for Opening of

New Dental Colleges


192 – 196

5. WHO Guidelines on Dengue & Chikungunya

World Health Organization

197 – 227

6. Dental Trauma Guidelines – Revised

International Association of

Dental Traumatology

228 – 254

7. Revised Bio Medical Waste Management Rules

2016

Govt. of India Gazette

Notification

255 – 292

8. Introduction & Guidelines for Starting a Diagnostic Installation


Board

293 – 296

9. Revised Guidelines for obtaining Regulatory

Consents for Diagnostic Equipment

AERB - Atomic Energy

Regulatory Board

297 – 299

10. Guidelines for shielding of X-ray Installations


Board

300 – 303

11. Guidelines for applying for License Diagnostic Radiology Equipment


Regulatory Board

304 – 329

12. Checklist for submission of application form for

registration


Regulatory Board

330 – 335

13. National Treatment Guidelines for

Antimicrobial Use

Antibiotics in Infectious Diseases

336 – 399

14. Registration and Import of Medical Devices in

India – Frequently Asked Questions

Central Drugs Standard Control

Organization

400 – 411


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Author Guidelines The Editor invites contributions for the IDA Ludhiana Branch E-Journal:

1. Systemized Review articles 2. Original Research articles 3. Short Communications 4. Clinical Case Reports Review articles: These provide an in-depth review of a specific topic by systematic critical assessments of literature and data sources. Appropriate use of tables and figures is encouraged. Where relevant, key messages and salient features may be provided up to 4000 words excluding references and abstract. Research articles: These scientific reports give results of original research. These should have a structured abstract (consisting of Background, Aims, Methods, Results & Conclusions) and should follow the IMRAD (Introduction, Methods, Results and Discussion) format (upto 2500 words). Short Communications: These are brief reports on research (approx. 1200 to 1500 words). A short report may include up to 3 tables or figures and 15 to 20 references. Clinical case reports: Previously undocumented disease process, a unique unreported manifestation or treatment of a known disease condition. (approx. 700 to 1200 words) will be given priority. Covering Letter The covering letter should outline the importance of the paper and its appropriateness for publication in the Journal. It should specify the section of the Journal for which the submitted article is to be considered. It should also explain, with reasons, if there is any deviation from the IMRAD format. If the work has been previously published in part or whole (e.g. as an abstract or proceedings of a conference), this must be stated. Any conflicts of interest, or their absence, must be stated in writing. Title Page This should contain the title, running title, 3-5 Keywords, names of all the authors (without degrees or diplomas), names and full location of the departments and institutions where the work was performed, name of the corresponding author, acknowledgement of financial support and abbreviations used. Superscripted numbers should be used after each authors name and the department and institution corresponding to each number should be specified on the page. Names of authors should appear in the order of authorship The title should be brief but complete and should represent the major theme of the manuscript. It should include the animal species if appropriate. A subtitle can be added if necessary. Abbreviations should not be used. The short title should not exceed 60 characters (including inter-word spaces). It will be used as a running head. The name, telephone and fax numbers, and complete e-mail and postal addresses of the author to whom communications and requests for off prints are to be sent should be mentioned in the title page. In general, the use of abbreviations is discouraged unless they help in improving the readability of the text. The expanded form of each abbreviation should precede its first use in the text unless it is a standard unit of measurement.


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Abstract The abstract (250 words) should be structured and a concise and accurate summary of the article and should not contain abbreviations, tables, figures, footnotes or references. It should not draw conclusions stronger or more expansive than those in the body of the paper. Briefly, the background should explain why the study was done, the methods provide how the study was done, the results provide the salient results along with important data and the conclusions briefly highlight the message of the study. Introduction The introduction should state why the study was carried out and what the specific aims of the study were. It should describe the background for the study (the available knowledge), its importance and its goals. It should be brief but complete enough for the reader to understand the reasons for the study without having to read previous publications on the subject. Methods The validity of a study is judged by the methods used. These should be described in sufficient detail to permit evaluation and duplication of the work by others. The following should be described in this section: Study design Setting Selection of participants (Sampling Technique) Interventions (Randomization & blinding, if applicable) Methods of measurement Data collection and processing Loss of data such as dropouts or patients lost to follow up Statistical methods used Ethical guidelines followed by the investigators Consort guidelines in cases of randomized control trials Results These should be concise and include only the tables and figures necessary to enhance understanding of the text. Suitable labels referring to the specific tables and figures must be mentioned in the text. Results should be presented in a logical, sequential order that parallels the organization of the methods section. The text should be used to highlight the most important aspects of the figures and tables, and to convey unique information. Data presented in tables and figures should not be duplicated in the text. Drug names, wherever used, should be generic. If the use of proprietary names is deemed a must for the study, generic names should be mentioned in parentheses. Units of Measurement SI units should be used. Temperature should be expressed in degrees Celsius and blood pressure in mmHg. Discussion The discussion should summarize how the study findings add to the current knowledge, provide explanations for the findings, compare the study’s findings with available studies, discuss the limitations of the study and the implications for future research. Only those published articles directly relevant to interpreting the results and placing them in context should be referenced. Do not repeat the results in the discussion. This section should conclude with a brief summary statement. The conclusion should be based on and justified by the results of the study. The particular relevance of the results to healthcare in India should be stressed. Conclusions regarding cost-benefit should be drawn only if a specific economic analysis formed a part of the study design.


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References References should be numbered in the order in which they appear in the text and these numbers should be inserted above the lines (superscripted) on each occasion the reference is cited (e.g. Sinha12 confirmed other reports13,14...). References included at the end of a sentence or part of a sentence should be placed after the punctuation mark. (Superscripting of the references is excusable/can be done away in some cases) References cited only in tables or in legends to figures should be numbered in accordance with the sequence established by the first identification in the text of the particular table or figure. Avoid using abstracts as references. For papers accepted but not yet published mention the name of the journal, the year of publication and add in press in parentheses. Information from papers submitted for publication but not accepted should be cited in the text as unpublished observations with written permission from the source. Avoid citing a personal communication unless it is essential; such citations must list in parentheses in the text the name of the person and date of communication. Written permission, obtained from the author of such communications for their use in the manuscript, must be submitted to the Journal. Do not include personal communications in the list of references. At the end of the article, the full list of references should include the names of authors, the full title of the journal article or book chapters; the title of journals abbreviated according to the Index Medicus style (www.nlm.nih.gov/bsd/uniform_requirements.html) the year of publication, the volume number and the first and final page numbers of the article or chapter. If there are six or fewer authors in the study being cited, the names of all the authors should be given. If there are more than six authors, the names of the first six authors should be given followed by et al. The authors should check that the references are accurate; lack of accuracy may result in the rejection of an otherwise adequate manuscript. Tables These should be typed in double space, each table on a separate page with the table number (in Roman numerals) and title above the table, and explanatory notes below the table. Tables should be so arranged that comparisons of interest are horizontal (across columns) and from left-to-right. The numbers of observations for each column or row (n) and marginal totals should be provided where appropriate. All abbreviations and symbols in the table must be explained in the footnote(s) to the table, even if the expanded forms have already been mentioned in the text. The units of measure must be mentioned. Figures Each image should be less than 400 kb in size. Size of the image can be reduced by decreasing the actual height and width of the images (keep up to 1024x760 pixels or 5 inches). All image formats (jpeg, tiff, gif, bmp, png, eps, etc.) are acceptable; jpeg is most suitable. Do not zip the files. Legends to figures These should be typed in double space on a separate sheet and figure numbers (in Arabic numerals), should correspond with the order in which the figures are presented in the text. The legend must include enough information to permit interpretation of the figure without reference to the text. Any labels or abbreviations within the figure must be explained in the legend. Authors All authors should have participated sufficiently in the work to take public responsibility for the content. All authors must sign an undertaking accepting responsibility for the submitted manuscript.


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Authors are required to state their exact contribution to the study; the Journal may print this information. The order of authorship should be decided by all the authors. The journal strongly discourages alterations in the sequence or deletion/addition of authors at any time after submission of the manuscript. Acknowledgements All contributors who do not meet the criteria for authorship should be listed in an Acknowledgements section. Examples of those who might be acknowledged include a person who provided purely technical help, or statistical or writing assistance. Financial and material support should also be acknowledged. Conflict of interest A conflict of interest exists when a financial or personal relationship of the author may inappropriately influence his or her actions. Conflicts may be personal, commercial, political, academic, or financial. Some examples of financial conflicts of interest include employment; research funding (received or pending), stock or share ownership, payment for lectures or travel, consultancies and non-monetary support. Conflicts, or their absence, must be stated in writing by all authors at the time of submission of the article. The Journal may use information disclosed in conflict of interest and financial interest statements as a basis for editorial decisions. Sources of full or partial funding or other support for the research must be declared. Copyright Authors must agree in writing to transfer to the Journal the copyright for all material submitted, in case of its publication by the Journal. The published manuscript may not be reproduced elsewhere, wholly or in part, without the prior written permission of the Journal. Plagiarism Plagiarism is the use of others published and unpublished ideas or words (or other intellectual property) without attribution or permission, and presenting them as new and original rather than derived from an existing source. This applies to all forms of documents, published (print or electronic) or unpublished. Authors should make sure that their manuscripts are free from plagiarized material. Providing a reference to the material quoted verbatim from previously published material does not absolve the user of plagiarism. Detection of plagiarism would lead to rejection of the manuscript and debar the publication of any material from the concerned authors for at least three years. The Journal may also send this information to the head of the institution where the authors work with a request for an inquiry in the matter. The Journal may also publish such correspondence in its pages to inform its readers of scientific misconduct. Editorial Process A manuscript will be reviewed for possible publication with the understanding that it is being submitted to L.E.D. E- Journal alone at that point in time and has not been published anywhere, simultaneously submitted, or already accepted for publication elsewhere. The journal expects that authors would authorize one of them to correspond with the Journal for all matters related to the manuscript. All manuscripts received are duly acknowledged. On submission, editors review all submitted manuscripts initially for suitability for formal review. Manuscripts with insufficient originality, serious scientific or technical flaws, or lack of a significant message are rejected before proceeding for formal peer-review. Manuscripts that are unlikely to be of interest to the L.E.D. E- Journal readers are also liable to be rejected at this stage itself.


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Manuscripts that are found suitable for publication in L.E.D. E- Journal are sent to two or more expert reviewers. During submission, the contributor is requested to provide names of two or three qualified reviewers who have had experience in the subject of the submitted manuscript, but this is not mandatory. The reviewers should not be affiliated with the same institutes as the contributor/s. However, the selection of these reviewers is at the sole discretion of the editor. The journal follows a double-blind review process, wherein the reviewers and authors are unaware of each other’s identity. Every manuscript is also assigned to a member of the editorial team, who based on the comments from the reviewers takes a final decision on the manuscript. The comments and suggestions (acceptance/ rejection/ amendments in manuscript) received from reviewers are conveyed to the corresponding author. If required, the author is requested to provide a point by point response to reviewers’ comments and submit a revised version of the manuscript. This process is repeated till reviewers and editors are satisfied with the manuscript. Manuscripts accepted for publication are copy edited for grammar, punctuation, print style, and format. Page proofs are sent to the corresponding author. The corresponding author is expected to return the corrected proofs within three days. It may not be possible to incorporate corrections received after that period. The whole process of submission of the manuscript to final decision and sending and receiving proofs is completed online. Copyright form The undersigned author transfers all copyright ownership of the manuscript (Title) to (IDA Journal Ludhiana print and online version) both–in the event the work is published. The undersigned author warrants that the article is original, is not under consideration for publication by another journal and has not been previously published. I sign for and accept responsibility for releasing this material on behalf of any and all co-authors. I declare that there is neither a direct quote from any other copyrighted material or author nor are there any tables or pictures. The laboratory work is done by (Name of the Laboratory) and the name, credential and address have been duly attributed at the end of the article. {If Applicable} Appropriate references to the various published articles from scientific publications with the name of the author and name of publication are given at the end of the article in a numbered fashion as well as the appropriate reference numbers are mentioned. We give the rights to the corresponding author to make necessary changes as per the request of the journal, do the rest of the correspondence on our behalf and he/she will act as the guarantor for the manuscript on our behalf. All persons who have made substantial contributions to the work reported in the manuscript, but who are not contributors, are named in the Acknowledgment and have given me/us their written permission to be named. If I/we do not include an Acknowledgment that means I/we have not received substantial contributions from non-contributors and no contributor has been omitted. Signatures (Digital)


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L.E.D. E-Journal

In our constant endeavour to keep you updated with the latest in

Dentistry, the IDA Ludhiana Branch official publication, ‘L.E.D.’ –

‘Let’s Enjoy Dentistry’, a monthly E-Journal brings you the Revised

Dentists (Code of Ethics) Regulations, 2014 brought about by

The Dental Council of India to regulate dental education & the

profession throughout India. Its main objectives are:

1. Maintain uniform standards of dental education in India – both at

Undergraduate and Postgraduate levels.

2. Regulate the curriculum and prescribe the standard curricula in

the training of dentists, dental hygienists and dental mechanics

3. Regulate the level of examinations and prescribe the standards of

examinations and other requirements to be satisfied to secure for

qualifications

To achieve these objectives, the needs are:

1. Uniformity of curriculum standards of technical and clinical

requirements, standards of examinations;

2. Affiliation of every dental college to an University;

3. Supervision over all the dental institutions to ensure that they

maintain the prescribed standards;

4. Regulation of the profession of dentistry.

The word "moral" is defined as relating to the principles of right and

wrong in behavior and "ethics" is defined as a system of moral values

or the principles of conduct governing an individual or a group and

deals with the values relating to human conduct, with respect to the

rightness and wrongness of certain actions and to the goodness and

badness of the motives and ends of such actions. Dentists should

build their reputation on their professional ability and integrity and

should abide by the regulations put forth by the Dental Council of

India (DCI). Hence, the need for the Code of Ethics for every dentist

in India.


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https://en.wikipedia.org/wiki/India

KDJ – Vol. 37 • No. 3 • July 2014 217

DENTAL COUNCIL OF INDIANOTIFICATION

New Delhi, the 27th June, 2014No. DE-97-2014.—In exercise of the powers conferred by Section 20 read with Section 17A of the Dentists Act, 1948(16 of 1948), the Dental Council of India with the previous sanction of the Central Government, in supersession of theDentists (Code of Ethics) Regulations 1976, except as respects things done or omitted to be done before suchsupersession, hereby makes the following Dental Council of India (Code of Ethics) Regulations :—1. Short title and Commencement :

1.1 These regulations may be called the Revised Dentists (Code of Ethics) Regulations, 2014.1.2 They shall come into force on the date of their publication in the Official Gazette of India.

2. Definitions :In these regulations, unless the context otherwise requires;2.1 ‘Act’ means the Dentists Act, 1948 (16 of 1948);2.2 ‘Council’ means the Dental Council of India;2.3 Dentist means any person with a register able dental degree (in Part A or Part B of the State Dental Register)

either by virtue of a prior registration with the Council or one who has been conferred a Bachelor of DentalSurgery (BDS) from any university recognized by the Council and shall be referred to as a Dentist or DentalSurgeon;

2.4 Post graduate dental degree refers to any postgraduate qualification such as M.D.S. in any discipline ofdentistry received by convocation from a University recognized by the Dental Council of India or any otherpost graduate qualification equivalent to MDS that is recognized by the Council;

2.5 All expressions used and not defined in these regulations shall have the meanings assigned to them in theAct and the regulations made there under from time to time.

CHAPTER 13. Code of Dental Ethics

A. Declaration :Every dentist who has been registered (either on Part A or Part B of the State Dentists Register) shall, withina period of thirty days from the date of commencement of these regulations, and every dentist who getshimself registered after the commencement of these regulations shall, within a period of thirty days fromsuch registration, make, before the Registrar of the State Dental Council, a declaration in the form set out forthe purpose in the Schedule to these regulations and shall agree to have read, understood and thence toabide by the same.

Revised Dentists (Code of Ethics) Regulations – 2014


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B. Duties and Obligation of Dentists in General3.1 Character of Dentist / Dental Surgeon

In view of the important role of a Dentist/ Dental Surgeon as a health professional educated and trained insurgical and medical treatment of diseases of the Oral cavity, he shall:(3.1.1) Be mindful of the high character of his mission and the responsibilities he holds in the discharge of

his duties as an independent health-care professional and shall always remember that care of thepatient and treatment of the disease depends upon the skill and prompt attention shown by him andalways remembering that his personal reputation, professional ability and fidelity remain his bestrecommendations;

(3.1.2) Treat the welfare of the patients as paramount to all other considerations and shall conserve it tothe utmost of his ability;

(3.1.3) Be courteous, sympathetic, friendly and helpful to, and always ready to respond to, the call of hispatients, and that under all conditions his behaviour towards his patients and the public shall bepolite and dignified;

3.2 Maintaining good Clinical Practices :The Principal objective of the Dental profession is to render service to humanity with full respect for thedignity of profession and man. Dental Surgeons should merit the confidence of patients entrusted to theircare, rendering to each a full measure of service and devotion. They should try continuously to improvemedical knowledge and skills and should make available to their patients and colleagues the benefits oftheir professional attainments. The Dentist/ Dental Surgeon should practice methods of healing foundedon scientific basis and should not associate professionally with anyone who violates this principle. Thehonoured ideals of the dental profession imply that the responsibilities of the Dental Professionals extendnot only to individuals but also to Society.(3.2.1) The Principal objective of the Dental profession is to render service to humanity with full respect

for the dignity of profession and man. Dental Surgeons should merit the confidence of patientsentrusted to their care, rendering to each a full measure of service and devotion. They should trycontinuously to improve medical knowledge and skills and should make available to their patientsand colleagues the benefits of their professional attainments. The Dentist/ Dental Surgeon shouldpractice methods of healing founded on scientific basis and should not associate professionallywith anyone who violates this principle. The honoured ideals of the dental profession imply thatthe responsibilities of the Dental Professionals extend not only to individuals but also to Society.

(3.2.2) Membership in Dental and Medical Associations and Societies: For the advancement of his/herprofession, a Dental Surgeon should be encouraged to affiliate with associations and societies ofdental, oral and allied medical professionals and play a proactive role in the promotion of oral healthin particular and health of an individual in general.

(3.2.3) A Dentist/Dental Surgeon should enrich his professional knowledge by participating in professionalmeetings as part of Continuing Dental and Medical Education programs/Scientific Seminars/Workshopsas stipulated by the regulations made by the statutory bodies from time to time and should registerany mandatory requirements with the state registration bodies or any other body as stipulated.

3.3 Maintenance of Dental/Medical records :(3.3.1) Every Dental surgeon shall maintain the relevant records pertaining to his outpatients and inpatients

(wherever applicable). These records must be preserved for a minimum period of three years fromthe date of commencement of the treatment in a format determined by the Council or accepted as astandard mode of documentation.

(3.3.2) If any request is made for medical or dental records either by the patients/authorized attendant orlegal authorities involved, the same may be issued to the competent authority within 72 hours afterhaving obtained a valid receipt for all documents. It is prudent to keep certified photocopies /carbon copies of such submissions.

(3.3.3) A Registered Dental practitioner shall maintain a Register of Medical Certificates giving full detailsof certificates issued. When issuing a medical certificate he shall always enter the identificationmarks of the patient and keep a copy of the certificate. He shall not omit to record the signature and/or thumb mark, address and at least one identification mark of the patient on the medical certificatesor report. The medical certificate shall be prepared as in Appendix 2 of this document, RevisedDentists Code of Ethics Regulations, 2012.

(3.3.4) Efforts shall be made to digitalize dental/ medical records for quick retrieval.3.4 Display of Registration Numbers :

(3.4.1) Every Dental practitioner shall display the registration number accorded to him by the State DentalCouncil in his clinic and in all his prescriptions, certificates and money receipts given to his patients.

(3.4.2) Dental Surgeons shall display as suffix to their names only recognized Dental degrees which arerecognized by the Council or other qualifications such as certificates/diplomas and memberships/



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KDJ – Vol. 37 • No. 3 • July 2014 219

honours/ fellowships which are conferred by recognized Universities/ recognized bodies approvedby the Council and obtained by convocation in person or in absentia. Any other qualificationssuch as medical degrees, doctorates, post-doctoral degrees or any degree that has bearing on theperson’s knowledge or exemplary qualification may be used as suffix in a manner that does notconvey to the observer or patient a false impression regarding the practitioner’s knowledge orability as a dental professional. Abbreviations of memberships in association or organizations ofprofessionals should not be used as abbreviations in a manner that is misleading to the public[refer to Article 8.9.3 of this document, Revised Dentists Code of Ethics Regulations, 2012 forrelevant details].

3.5 Prescription of Drugs :Every dental surgeon should take care to prescribe and administer drugs in a responsible manner andensure safe and rational use of drugs. He should as far as possible, prescribe drugs in a generic form.

3.6 Highest Quality Assurance in patient care :Every Dental practitioner should ensure quality treatment that does not compromise the outcome of treatment.He must be vigilant about malpractice by other practitioners that may jeopardize the lives of others and whichare likely to cause harm to the public. All practitioners should be aware of unethical practices and practices byunqualified persons. Dentists/ Dental Surgeons shall not employ in connection with their professional practiceany attendant who is neither registered nor enlisted under the Dentists Act and shall not permit such personsto attend, treat or perform operations upon patients wherever professional discretion or skill is required.

3.7 Exposure of Unethical Conduct :A Dental Surgeon should expose, without fear or favour, incompetent or corrupt, dishonest or unethicalconduct on the part of members of the profession. It is the responsibility of the dental surgeon to report tothe competent authorities’ instances of quackery and any kind of abuse including doctor-patient sexualmisconduct, misuse of fiduciary relationship, child abuse and other social evils that may come to theirattention.

3.8 Payment of Professional Services :The Dental Surgeon, engaged in the practice of his profession shall give priority to the interests ofpatients. The personal financial interests of a dental surgeon should not conflict with the medical interestsof patients. A dental practitioner should announce his fees before rendering service and not after theoperation or treatment is under way. Remuneration received for such services should be in the form andamount specifically announced to the patient at the time the service is rendered. It is unethical to enter intoa contract of “no cure - no payment”. Dental Surgeons rendering service on behalf of the State shall refrainfrom anticipating or accepting any consideration. While it is not mandatory to offer free consultations tofellow dental or medical professionals and their immediate family, it will be deemed a courtesy to offer freeor subsidized consultations and treatment to them in situations where no significant expenses are incurred.

3.9 Observation of Statutes :The Dental Surgeon shall observe the laws of the country in regulating the practice of his professionincluding the Dentists’ Act 1948 and it’s amendments and shall also not assist others to evade such laws.He should be cooperative in observance and enforcement of sanitary laws and regulations in the interestof public health. He should observe the provisions of the State Acts like Drugs and Cosmetics Act, 1940;Pharmacy Act, 1948; Narcotic Drugs and Psychotropic substances Act, 1985; Environmental ProtectionAct, 1986; Drugs and Magic Remedies (Objectionable Advertisement) Act, 1954; Persons with Disabilities(Equal Opportunities and Full Participation) Act, 1995 and Bio-Medical Waste (Management and Handling)Rules, 1998 and such other Acts, Rules, Regulations made by the Central/State Governments or localAdministrative Bodies or any other relevant Act relating to the protection and promotion of public health.

3.10 Signing Professional Certificates, Reports and other Documents :A Registered Dental Surgeon involved independently in the treatment of dental and oral surgical problemsmay be called upon to sign certificates, notifications, reports etc. He is bound to issue such certificates andto sign them. Documents relating to disability, injury in the oral and maxillofacial region and deaths occurringwhile under the care of such dental surgeons should be signed by them in their professional capacity forsubsequent use in the courts or for administrative purposes etc. Such documents, among others, includethe ones given at Appendix 4. Any registered dental surgeon who is shown to have signed or given underhis name and authority any such certificate, notification, report or document of a similar character which isuntrue, misleading or improper, is liable to have his name deleted from the Register.

CHAPTER 24 DUTIES OF DENTAL PRACTITIONERS TO THEIR PATIENTS

4.1 Obligations to Patients(4.1.1) Though a Dental Surgeon is not bound to treat each and every person asking his services, he

should attend emergencies reporting to the clinic and should be mindful of the high character of



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KDJ – Vol. 37 • No. 3 • July 2014220

his/her mission and the responsibility he discharges in the course of his professional duties. TheDental Surgeon should see patients at their hour of appointment as far as possible unless he isunable to do so due to unforeseen delays. He should never forget that the health and the lives ofthose entrusted to his care depend on his skill and attention. A Dental Surgeon should endeavourto add to the comfort of the sick by making his visits at the hour indicated to the patients. A Dentalsurgeon advising a patient to seek service of another Dental Surgeon or physician is acceptable.However in the case of medical emergency a Dental Surgeon must institute standard care includingresuscitation in case of cardiac episodes, for which all dental surgeons must be adequately trainedin basic life support.

(4.1.2) A Dental Surgeon can refuse treatment using his discretion but it should not be on the basis of anydiscrimination of colour, caste, religion, nationality or the presence of ailments such as HIV or othercontagious diseases. However in keeping with the dictum of medical care, the dental surgeon must‘continue to treat’ if he/she has accepted the patient for treatment. Treatment can be terminated on thewishes of the patient or with the resolution of the complaint for which the patient sought treatment.Treatment can also be terminated if the patient is in need of additional or expert care for which the Dentalsurgeon is not equipped to treat or if it falls outside the range of his expertise. In such instances, thepatient should be referred to such specialists or higher centres where treatment is possible.

(4.1.3) A Dental Practitioner having any incapacity detrimental to the patient or which can affect hisperformance vis-a-vis the patient is not permitted to practice his profession.

4.2 Confidentiality :Confidences concerning individual or domestic life entrusted by patients to a Dental Surgeon and defectsin the disposition or character of patients observed during professionally attending to a patient shouldnever be revealed unless such a revelation is required by the laws of the State. Sometimes, however, aclinician must determine whether his duty to society requires him to employ knowledge, obtained throughconfidence as a health care provider to protect a healthy person against a communicable disease to whichhe is about to be exposed. In such instance, the Dental Surgeon should act as he would wish another to acttoward one of his own family in like circumstances.

4.3 Prognosis :The Dental Surgeon should neither exaggerate nor minimize the gravity of a patient’s disease. He shouldensure himself that the patient, his relatives or his responsible friends have such knowledge of the patient’scondition as will serve the best interests of the patient and the family.

4.4 The Patient must not be neglected :A Dental surgeon is free to choose whom he will serve. He should, however, respond to any request for hisassistance in an emergency. Once having undertaken a case, the Dental Surgeon should not neglect the patient,nor should he withdraw from the case without giving adequate notice to the patient and his family. He shall notwilfully commit an act of negligence that may deprive his patient or patients from necessary Dental/Medical care.

CHAPTER 35 DUTIES OF DENTAL SURGEONS AND SPECIALISTS IN CONSULTATIONS

5.1 Consultation Etiquettes:(5.1.1) A Dental Surgeon should ordinarily be able to deal with all common diseases of the Oral cavity by

virtue of his qualification and training. However, if the patient requires expert care of a specialist,appropriate references to Dental or Medical specialists may be made according to the nature of theproblem. It is the duty of a specialist to refer the patient back to the patient’s original dentist afterthe treatment for which the referral was made. While the specialist can collect his or her fees itwould be unethical to pay commissions or any kind of gratuity to the referring dental surgeon.

(5.1.2) A Dental Surgeon shall not receive from the radiologist, laboratory or dispensing chemist any kindof commission in the form of money, gifts or gratuity for referrals. All referrals for investigationshould be judicious, justifiable and done in the best interests of the patient to arrive at a diagnosis.

5.2 Consultation for Patient’s Benefit:In every consultation, the benefit to the patient is of foremost importance. All Dental Surgeons engaged inthe case should be frank with the patient and his attendants.

5.3 Punctuality in Consultation:Punctuality for consultations should be observed by a Dental Surgeon except in the case of unavoidableprofessional delays which are justifiable.

5.4 Opinions and Disclosure:(5.4.1) All statements to the patient or his representatives made by any Consulting Healthcare Professional

and/or the paramedical staff(nurses, etc.,) should take place in the presence of the Dental Surgeon,except as otherwise agreed. The disclosure of the opinion to the patient or his relatives or friendsshall rest with the Dental Surgeon.



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(5.4.2) Differences of opinion should not be divulged to the patient unnecessarily but when there isirreconcilable difference of opinion the circumstances should be frankly and impartially explained to thepatient or his relatives or friends. It would be up to them to seek further advice, if they so desire.

5.5 Treatment after Consultation:No decision should restrain the attending Dental Surgeon from making such subsequent variations in thetreatment if any unexpected change occurs, but at the next consultation, reasons for the variations shouldbe discussed/ explained. The same privilege, with its obligations, belongs to the consultant when sent forin an emergency during the absence of attending Dental surgeon. The attending Dental Surgeon mayprescribe medicine at any time for the patient, whereas the consultant may prescribe only in case ofemergency or as an expert when called for.

5.6 Patients Referred to Specialists:When a patient is referred to a specialist by the attending Dental surgeon, a case summary of the patientshould be given to the specialist, who should communicate his opinion in writing to the attending Dentalsurgeon.

5.7 Fees and other charges:(5.7.1) A Dental Surgeon or the Clinic run by him shall clearly indicate the cost of treatment for the procedure

and make an estimate of all costs likely to be incurred. Any increase in subsequent cost should bejustified by the Dental surgeon. There is no bar on the display of fees and other charges in the DentalClinic. Prescription should also make it clear if the Dental Surgeon himself dispensed any medicine.

(5.7.2) A Dental Surgeon shall write his name and designation in full along with the recognized dentaldegrees and the registration particulars in his prescription letter head.

Note: In Government hospitals where the patient-load is heavy, the name of the prescribing doctor must bewritten below his signature.

CHAPTER 46 RESPONSIBILITIES OF DENTAL SURGEONS TO ONE ANOTHER

6.1 Dependence of Dental Surgeons to each other:A Dental Surgeon should consider it as a pleasure and privilege to render gratuitous service to otherdentists, physicians and their immediate family dependants. However there is no mandatory bar on oneaccepting fees particularly when it involves expensive materials and time.

6.2 Conduct in Consultation:In consultations, no insincerity, rivalry or envy should be indulged in. All due respect should be observedtowards the Dental Surgeon/physician in-charge of the case and no statement or remark be made, whichwould impair the confidence reposed in him. For this purpose no discussion should be carried on in thepresence of the patient or his representatives.

6.3 Consultant not to take charge of the case:When a specialist Dental Surgeon has been called for consultation, the Consultant should normally nottake charge of the case, especially on the solicitation of the patient or friends. The Consultant shall notcriticize the referring Dental Surgeon. He shall discuss the diagnosis treatment plan with the referringDental Surgeon.

6.4 Appointment of Substitute:Whenever a Dental Surgeon requests another Dental Surgeon to attend his patients during his temporaryabsence from his practice, professional courtesy requires the acceptance of such appointment only whenhe has the capacity to discharge the additional responsibility along with his other duties. The DentalSurgeon acting under such an appointment should give the utmost consideration to the interests andreputation of the absent Dental Surgeon and all such patients should be restored to the care of the latterupon his return.

6.5 Visiting another Case:When it becomes the duty of a Dental Surgeon occupying an official position to see and report upon acondition and appropriate treatment, he should communicate to the Dental Surgeon in attendance so as togive him an option of being present. The Medical Officer/Dental Surgeon occupying an official positionshould avoid remarks upon the diagnosis or the treatment that has been adopted.

CHAPTER 57 DUTIES OF DENTAL SURGEONS TO THE PUBLIC AND TO THE PARAMEDICAL PROFESSION

7.1 Dental Surgeons as Citizens:Dental Surgeons, as good citizens, possessed of special training should disseminate advice on publichealth issues. They should play their part in enforcing the laws of the community and in sustaining theinstitutions that advance the interests of humanity. They should particularly co-operate with the authoritiesin the administration of sanitary/public health laws and regulations.



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7.2 Public and Community Health:Dental Surgeons, especially those engaged in public health dentistry, should enlighten the public concerningoral health and prevention of oral diseases such as dental caries, periodontal health, precancerous lesionsand oral cancer. At all times the dental surgeons should notify the constituted public health authorities orhospitals of every case of communicable disease under his care, in accordance with the laws, rules andregulations of the health authorities.

7.3 Pharmacists /Nurses:Dental Surgeons should recognize and promote the practice of different paramedical services such asDental Hygienist, Dental Mechanic, Pharmacy and Nursing as professions and should seek their cooperationwherever required.

CHAPTER 68 UNETHICAL ACTS:

A Dental Surgeon shall not aid or abet or commit any of the following acts which shall be construed as unethical.For the purpose of this regulations a dental surgeon refers to all registered practitioners whether they are inindividual private practice, attached to hospitals, teaching hospitals or employed by others whether they arecorporate or otherwise:8.1 Advertisement:

The global position on the issue of Ethics of Advertisement by Dental/Medical professionals has drasticallychanged over the last few decades. A Dentist or a group of Dentists may advertise provided that theymaintain decorum, keeping in mind the high moral obligations and the value that society places on theimportant nature of their work and the moral character and integrity expected of them. Dental Surgeons areexpected to exhibit integrity, honesty, fidelity and selfless service. Monetary commitments can only besecondary to the welfare of his patients. Under these circumstances it is unethical:(8.1.1) To indulge in demeaning solicitation and false promises through advertisements or direct marketing

of individuals, clinics or hospitals in contravention of the National Advertising Council or anyother body regulating advertising in the country;

(8.1.2) To advertise, whether directly or indirectly or being associated or employed with any organizationor company including corporate bodies that indulges in such activities in a manner which givesunfair professional advantage by cold targeting vulnerable groups and conducting camps andother promotional activity in schools, colleges, old age homes and distributing handbills, claimvouchers and other business promotional activities. Registered charitable organizations includingregistered body of Dental or Medical persons which provide fully free dental care and treatment outof altruism are however exempted;

(8.1.3) To be associated with or employed by those who procure or sanction such false and misleadingadvertisements or publication through press reports that promise inducements, rebates and falsebenefits;

(8.1.4) To employ any agent or canvasser for the purpose of obtaining patients in a manner that iscommercial; or being associated with or employed by those who procure or sanction of suchemployment;

(8.1.5) To use or exhibit any disproportionately large sign, other than a sign which in its character, position,size and wording is merely such as may reasonably be required to indicate to persons seeking theexact location of, and entrance to, the premises at which the dental practice is carried on, andnowhere else;

(8.1.6) To allow the Dental Surgeon’s name to be used to designate commercial articles such as toothpaste, tooth brush, tooth powder, mouth washes liquid cleaners, or the like except if such articlesare fabricated in the dental clinic e.g. dentures, crowns, bridges, etc.;

(8.1.7) To permit publication of the Dental Surgeon’s opinion on any procedure, equipment, in the generalor lay papers or lay journals except when validated or supported by evidence based studies;

(8.1.8) To indulge in surrogate advertisements in the garb of educating the public through TV programs,magazines or periodicals. Any public information disseminated to the public in good faith andintention should not carry addresses telephone numbers, e-mail addresses etc., of the DentalSurgeon or the clinic employing him to attract patients to their establishment;

(8.1.9) To advertise in the electronic media, such as in television programs, that display names, addressesand telephone number of dentists as on-screen ‘scrollers’, or, of the clinics employing such dentists,etc.

8.2 Soliciting:Soliciting of patients, directly or indirectly, by a Dental Surgeon, by a group of Dental Surgeons or byinstitutions or organizations is unethical except when permitted under the provisions mentioned later (vide8.2.1 to 8.2.10 of this document, Revised Dentists Code of Ethics Regulations, 2012). A Dental Surgeon shall



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KDJ – Vol. 37 • No. 3 • July 2014 223

not make use of himself (or his name) as subject of any form or manner of advertising or publicity through anymode either alone or in conjunction with others which is of such a character as to invite attention to him or tohis professional position, skill, qualification, achievements, attainments, specialties, appointments,associations, affiliations or honors and/or of such character as would ordinarily result in his self-aggrandizement.A Dental Surgeon shall not give to any person, whether for compensation or otherwise, any approval,recommendation, endorsement, certificate, report or statement with respect of any drug, medicine, nostrumremedy, surgical, or therapeutic article, apparatus or appliance or any commercial product or article withrespect of any property, quality or use thereof or any test, demonstration or trial thereof, for use in connectionwith his name, signature, or photograph in any form or manner of advertising through any mode nor shall heboast of cases, operations, cures or remedies or permit the publication of report thereof through any mode.A Dental Surgeon is however permitted as an ethically acceptable practice to make a formal announcementin press regarding the following:(8.2.1) On starting practice.(8.2.2) On change of type of practice.(8.2.3) On changing address.(8.2.4) On temporary absence from duty for a prolonged period of time.(8.2.5) On resumption of practice after a break a prolonged period.(8.2.6) On succeeding to another practice.(8.2.7) About the availability of new equipment or services without boastful claims of being the ‘best’ or

‘first’ especially if such services are already available in other facilities.(8.2.8) Through insertion in Telephone directories, Yellow pages or on the internet is permissible and will

only serve as public information. However any claim to superiority or special skills over others willbe construed as unethical practice.

(8.2.9) Through maintenance of websites about dentists or dental clinics where all information is factualwill not be construed as unethical practice. Websites can also carry details of treatment facilitiesavailable and the fees for the same. This will in fact help patients to make informed choices througha transparent system. However websites should not make claims or statements that are not factualand therefore misleading to the public.

8.3 Publicity and Signage:(8.3.1) Printing of self-photograph, or any such material of publicity in the letter head or on sign board of

the consulting room or any such clinical establishment shall be regarded as acts of self-advertisementand unethical conduct on the part of the physician. However, printing of sketches, diagrams,picture of human system shall not be treated as unethical;

(8.3.2) Using or exhibition of any sign, other than a sign which in its character, position, size and wordingis merely such as may reasonably be required to indicate to persons seeking the exact location of,and entrance to, the premises at which the dental practice is carried on is considered unethical.These include:(8.3.2.1) Use of sign-board with the use of such words which trivialize the dignity of the profession

or notices in regard to practice on premises other than those in which a practice is actuallycarried on, or show cases, or flickering light signs and the use of any sign showing anymatter other than his name and qualifications as defined under Clause (j) of Section 2 ofthe Act;

(8.3.2.2) Affixing a sign-board on a Chemist’s shop or in places where the dentist does not resideor work.

(8.3.3) A Dental Surgeon shall not claim to be a specialist either through displayed signs on the nameboard and / or the office stationary (visiting cards, letterheads, etc.,) unless he has a specialqualification (which is recognized by the Council) in that Specialty. A Dental Surgeon can howeverpractice all branches of Dentistry provided he shows adequate qualification, competence and bonafide training in the concerned branch or branches.

8.4 Patent and Copyrights:A Dental Surgeon may patent surgical instruments, appliances and medicine or Copyright applications,methods and procedures. However, it shall be unethical if the benefits of such patents or copyrights are notmade available in situations where the interest of large population is involved.

8.5 Running an Open Shop (Dispensing of Drugs and Appliances by Physicians):A Dental Surgeon should not run an open shop for sale of medicine for dispensing prescriptions prescribedby doctors other than him or for sale of dental medical or surgical appliances. It is not unethical for a DentalSurgeon to prescribe, supply or sell drugs, remedies or dental appliances in his clinic as long as there is noexploitation of the patients. Drugs prescribed by a Dental Surgeon or brought from the market for a patientshould explicitly state the proprietary formulae as well as generic name of the drug.



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KDJ – Vol. 37 • No. 3 • July 2014224

8.6 Rebates and Commission:(8.6.1) A Dental Surgeon shall not give, solicit, or receive nor shall he offer to give solicit or receive, any

gift, gratuity, commission or bonus in consideration of or return for the referring, recommending orprocuring of any patient for dental, medical, surgical or other treatment. A Dental Surgeon shall notdirectly or indirectly, participate in or be a party to act of division, transference, assignment,subordination, rebating, splitting or refunding of any fee for medical, surgical or other treatment.

(8.6.2) Provisions of Section 8.6.1 (of this document, Revised Dentists Code of Ethics Regulations, 2012)shall apply with equal force to the referring, recommending or procuring by a physician or anyperson, specimen or material for diagnostic purposes or other study / work. Nothing in this section,however, shall prohibit payment of salaries by a qualified physician to other duly qualified personrendering medical care under his supervision.

8.7 Secret Remedies:The prescribing or dispensing by a physician of secret remedial agents of which he does not know thecomposition, or the manufacture or promotion of their use is unethical and as such prohibited. All the drugsprescribed by a dental surgeon should always carry a proprietary formula and clear name.

8.8 Human Rights:The physician shall not aid or abet torture nor shall he be a party to either infliction of mental or physicaltrauma or concealment of torture inflicted by some other person or agency in clear violation of humanrights.

8.9 Unethical Practices:The following shall also be the unethical practices for a Dentist:(8.9.1) A Dental Surgeon shall not employ a Dentist / Dental Surgeon in the professional practice or any

other professional assistant (not being a registered dental hygienist or a registered dental mechanic)whose name is not registered in the State Dentists Register, to practice Dentistry as defined inClause (d) of Section 2 of the Act. He may however retain the services of a medical practitioner oranaesthetist as necessary;

(8.9.2) Signing under his name and authority any certificate which is untrue, misleading or improper, orgiving false certificates or testimonials directly or indirectly to any person or persons;

(8.9.3) Use of abbreviations after the Dental Surgeon’s name except those indicating dental qualificationsas earned by him during his academic career in dentistry and which conform to the definition of‘recognized dental qualification’ as defined in Clause (j) of Section 2 of the Act, or any otheracademic qualifications from a recognized university obtained through a convocation indicatingexemplary achievement. Any degree conferred on an honorary basis should be suffixed with thewords “Honoris Causa”. Such unacceptable abbreviations include, but not necessarily restrictedto the following which are not academic qualifications:(8.9.3.1) R.D.P. for Registered Dental Practitioner;(8.9.3.2) M.I.D.A. for Member, Indian Dental Association;(8.9.3.3) F.I.C.D. for Fellow of International College of Dentists;(8.9.3.4) M.I.C.D. for Master of International College of Dentists;(8.9.3.5) F.A.C.D. for Fellow or American College of Dentists;(8.9.3.6) M.R.S.H. for Member of Royal Society of Hygiene;(8.9.3.7) F.A.G.E. for Fellow of Academy of General Education, etc.;

(8.9.4) Submission of false information in declaration form at the time of assessment of Dental College.(8.9.5) Serving as (Duplicate faculty) i.e. working simultaneously in two/more Dental Colleges.(8.9.6) Conviction for any crime by any court will constitute unethical act.

8.10 Naming and Styling of Dental Establishments:A Dental Surgeon or a group of Dentists/ Dental Surgeons shall refer to their establishment as a dentalclinic. It may however be referred to as a dental hospital if the practice involves surgical treatment of oraland dental diseases under local or general anaesthesia and if the patients need to be maintained as an in-patient for part of a day or for several days for post-operative care provided the hospital fulfils the statutoryrequirements for such hospitals or establishments in the respective States.

8.11 Contravention of Statutory Provisions:A Dental Surgeon shall not contravene any of the acts referred to in Article 3.9 of this document, RevisedDentists Code of Ethics Regulations, 2014, and named in Annexure 3 of the same document and the rulesmade there under as amended from time to time, involving an abuse of privileges conferred there underupon a dentist, whether such contravention has been the subject of criminal proceedings or not.

8.12 Signing of Certificates:A Registered Dental Surgeon is bound by law to give, or may from time to time be called upon or requestedto give certain certificates, notification, reports and other documents of similar character signed by them in



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KDJ – Vol. 37 • No. 3 • July 2014 225

their professional capacity for subsequent use in the courts, or elsewhere for administrative purposes, etc.Such documents, among others, include the ones given at Appendix 4 of this document, Revised DentistsCode of Ethics Regulations, 2014. A Dental Surgeon shall not sign under his name and authority anycertificate which is untrue, misleading or improper, or give false certificates or testimonials directly orindirectly to any person or persons. He shall however deem it his duty to sign all necessary certificatesrelating to health of the patients.

8.13 Doctor-Patient Sexual Misconduct:A Dental Surgeon shall not be involved in immorality involving abuse of professional relationship andinvolve in sexual misconduct with a patient by misusing fiduciary relationship.

8.14 Abiding by all Laws of the Land:A Dental Surgeon shall not aid or abet in any violation of the laws of the land or be involved in any matterthat is against public policy. He shall not be convicted by a court of law for offences involving moralturpitude/ criminal acts.

8.15 Relationship with Pharmaceutical Companies and Medical and Dental Industry:8.15.1Gifts, Travel, Hospitality, Monetary Grants:

A Dental Surgeon shall not receive any gift from any pharmaceutical or allied health care industryand their sales people or representatives. A Dental Surgeon shall not accept any travel facilityinside the country or outside, including rail, air, ship, cruise tickets, paid vacations etc. from anypharmaceutical or allied healthcare industry or their representatives for self and family members forvacation or for attending conferences, seminars, workshops, CDE/CME program etc., as a delegate.A Dental Surgeon shall not receive any cash or monetary grants from any pharmaceutical and alliedhealthcare industry for individual purpose in individual capacity under any pretext. Funding formedical research, study etc. can only be received through approved institutions and ProfessionalOrganizations by modalities laid down by law / rules / guidelines adopted by such approvedinstitutions, in a transparent manner. It shall always be fully disclosed.

8.15.2Dental / Medical Research:A Dental Surgeon may carry out, participate in, and work in research projects funded bypharmaceutical and allied healthcare industries. A Dental Surgeon is obliged to know that thefulfillment of the following items [8.15.2.1 to 8.15.2.7 of this document, Revised Dentists Code ofEthics Regulations, 2012] will be an imperative for undertaking any research assignment / projectfunded by industry - for being proper and ethical. Thus, in accepting such a position a Dentalsurgeon shall:(8.15.2.1)Ensure that the particular research proposal(s) has the due permission from the competent

concerned authorities.(8.15.2.2)Ensure that such a research project(s) has the clearance of national/state/ institutional

ethics committees/bodies.(8.15.2.3) Ensure that it fulfils all the legal requirements prescribed for medical research.(8.15.2.4) Ensure that the source and amount of funding is publicly disclosed at the beginning

itself.(8.15.2.5) Ensure that proper care and facilities are provided to human volunteers, if they are

necessary for the research project.(8.15.2.6) Ensure that undue animal experimentations are not done and when these are necessary

they are done in a scientific and a humane way.(8.15.2.7) Ensure that while accepting such an assignment a Dental Surgeon shall have the freedom

to publish the results of the research in the greater interest of the society by insertingsuch a clause in the MOU (Memorandum of Understanding) or any other document /agreement for any such assignment.

8.15.3 Maintaining Professional Autonomy:In dealing with pharmaceutical and allied healthcare industry, a Dental Surgeon shall always ensurethat there shall never be any compromise either with his/her own professional autonomy and / orwith the autonomy and freedom of the medical institution.

8.15.4 Affiliation:A Dental Surgeon may work for pharmaceutical and allied healthcare industries in advisorycapacities, as consultants, as researchers, as treating doctors or in any other professional capacity.In doing so, a medical practitioner shall always:(8.15.4.1) Ensure that his professional integrity and freedom are maintained.(8.15.4.2) Ensure that patients’ interest is not compromised in any way.(8.15.4.3) Ensure that such affiliations are within the law.(8.15.4.4) Ensure that such affiliations/employments are fully transparent and disclosed.



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8.15.5 Endorsement:A Dental surgeon shall not endorse any drug or product of the industry publically. Any studyconducted on the efficacy or otherwise of such products shall be presented to and / or throughappropriate scientific bodies or published in appropriate scientific journals in a proper way.

CHAPTER 79 PUNISHMENTS AND DISCIPLINARY ACTIONS:

A Dental Surgeon shall not aid or abet or commit any acts which shall be construed as unethical.9.1 It must be clearly understood that the instances of offences and unethical conducts which are given above

do not constitute and are not intended to constitute a complete list of the infamous acts which calls fordisciplinary action, and that by issuing this notice the Dental Council of India and or State Dental Councilsare in no way precluded from considering and dealing with any other form of professional misconduct onthe part of a registered practitioner. Circumstances may and do arise from time to time in relation to whichthere may occur questions of professional misconduct which do not come within any of these categories.Every care should be taken that the code is not violated in letter or spirit. In such instances as in all others,the Dental Council of India and/or State Dental Councils have to consider and decide upon the factsbrought before the Dental Council of India and/or State Dental Councils.

9.2 It is made clear that any complaint with regard to professional misconduct can be brought before theappropriate Dental Council for Disciplinary action. Upon receipt of any complaint of professional misconduct,the appropriate Dental Council would hold an enquiry and give opportunity to the registered Dentalpractitioner to be heard in person or by pleader. If the Dentist/ Dental Surgeon is found to be guilty ofcommitting professional misconduct, the appropriate Dental Council may award such punishment as deemednecessary or may direct the removal altogether or for a specified period, from the register the name of thedelinquent registered practitioner. Deletion from the Register shall be widely publicized in local press aswell as in the publications of different Medical and Dental Associations/ Societies/Bodies.

9.3 In case the punishment of removal from the register is for a limited period, the appropriate Council may alsodirect that the name so removed shall be restored in the register after the expiry of the period for which thename was ordered to be removed.

9.4 Decision on complaint against delinquent Dental Surgeons shall be taken within a time limit of 6 months.9.5 During the pendency of the complaint the appropriate Council may restrain the Dental Surgeon from

performing the procedure or practice which is under scrutiny.9.6 Professional incompetence shall be judged by peer group as per guidelines prescribed by State Dental

Council. For this purpose the State Dental Council shall institute an Ethics Committee consisting of qualifiedpersons of integrity and good name from amongst prominent registered Dental Surgeons in the State.

9.7 Where either on a request or otherwise the State Government or any competent authority is informed thatany complaint against a delinquent practitioner has not been decided by a State Dental Council within aperiod of six months from the date of receipt of complaint by it and further the State Government or anycompetent authority has reason to believe that there is no justified reason for not deciding the complaintwithin the said prescribed period, the State Government or any competent authority may.(9.7.1) Impress upon the concerned State Dental Council to conclude and decide the complaint within a

time bound schedule.(9.7.2) May decide to refer the said complaint pending with the concerned State Dental Council straightaway

or after the expiry of the period which had been stipulated by the Regulation in accordance withpara (9.7.1 of this document, Revised Dentists Code of Ethics Regulations, 2012) above, to itselfand refer the same to the Ethical Committee of the State Dental Council for its expeditious disposalin a period of not more than six months from the receipt of the complaint with the State Government.

9.8 Any person aggrieved by the decision of the State Dental Council on any complaint against a delinquentDental Surgeon, shall have the right to file an appeal to the State Government within a period of 60 daysfrom the date of receipt of the order passed by the said State Dental Council. Provided that the StateGovernment may, if it is satisfied that the appellant was prevented by sufficient cause from presenting theappeal within the aforesaid period of 60 days, allow it to be presented within a further period of 60 days.

Col. (Retd.) Dr. S.K. OJHA, Officiating Secy.[ADVT. III/4/Exty./98/14]

Foot Note : The Principal Regulations, namely, the “Dentists (Code of Ethics) Regulations, 2014”, were published inPart II, Section 3, Sub-sec (1) of the Gazette of India, Extraordinary, on 21.08.1976.

KDJ – Vol. 37 • No. 3 • July 2014226



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INFORMATION HAND BOOK

a AnR- RIGHT TO

INFORMATION

ti-Tr-t-thzr gRaq DENTAL COUNCIL OF INDIA

4-efff 45, ROI - 110 002 Aiwan-E-Galib Marg, Kotla Road,

New Delhi — 110 002

s 23238542, 23236740 Telephone 2 23238542, 23236740

E-mail tAR s [email protected] Website s www.dciindia.org.in


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INDEX

Sr. No. Topic Page No.

1 CHAPTER -1 The Particulars of its organisation, function and duties

2 CHAPTER -2 The powers and duties of officers and employees

3 CHAPTER -3 Procedure followed in decision making process, including channels of supervision and accountability

4 CHAPTER -4 The norms set by it for discharge of its functions

5 CHAPTER -5 The rules, regulations, instruction, manuals and records, held by its or under its control or used by its employees for discharging its functions

6 CHAPTER -6 A statement of the categories of documents that are held by it or under its control

7 CHAPTER -7 The particulars of any arrangement that exists for consultation with, or representation by, the members of the public in relation to the formulation of its policy or implementation thereof

8 CHAPTER -8 Boards, Councils, Committees and other Bodies consisted as part of Public Authority.

9 CHAPTER -9 A directory of its officers and employees and their monthly remuneration received by each of its officers and employees, including the system of compensation as provided in its regulations


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INDEX

Sr. No. Topic Page No.

10 CHAPTER -10 The budget allocated to each of its agency, indicating the particulars of all plans, proposed expenditure and reports on disbursements made and etc.

11 CHAPTER -11 Particulars of recipients of concessions, permits or authorization granted by the Public Authority

12 CHAPTER -12 Details in respect of the information, available to or held by it, reduced in an electronic form

13 CHAPTER -13 The names, designations and other particulars of the Public Information Officers;

14 CHAPTER -14 The particulars of facilities available to citizens for obtaining information, including the working hours of a library or reading room, if maintained for public use


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CHAPTER -1

The particulars of its organisation, function and duties

1. Brief History

The Dental Council of India - a statutory body - was constituted on 12th April

1949 under an Act of Parliament - the Dentists Act, 1948 (XVI of 1948). The

amendments were made through an ordinance promulgated by the President

of India on 27th August 1992. Through this ordinance, new sections i.e.

section 10A, section 10B, section 10C were introduced in the Dentists Act,

1948 mainly to restrict mushroom growth of dental colleges, increase of the

seats in any of the course and starting of new higher courses without the

prior permission of the Central Govt., Ministry of Health & Family Welfare. The

amendment was duly notified by the Govt. of India in Extraordinary Gazette

of India, Part II, Section I on 3rd April 1993 with effective date 1st June 1992

The Dental Council of India is constituted by an Act of Parliament 'The

Dentist Act 1948 (XVI of 1948) with a view to regulate the Dental Education,

Dental Profession and Dental Ethics, thereto-which came into existence in

March, 1949. The Dentists Act 1948 has been amended in the year 1993,

2010.

2. Objectives

The Council has been constituted to achieve the following objectives:

a) Maintenance of uniform standards of dental educational, both under

graduate and post graduate.

b) Recommendation for recognition/de-recognition of dental qualification

of dental institutions of India or foreign countries.

c) Maintenance of Indian Dental Register by the concerned State Dental

Councils.

d) Reciprocity with foreign countries in the matter of mutual recognition

of dental qualifications.


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3. Functions and Duties

a) Recommendation to the Central Government for grant of permission to

establish a new Dental College or opening of a new of higher course of

study or training or increase in admission capacity in any course of

study or training.

b) Inspection/visitation with a view to maintain minimum standard of

dental education in India.

c) Recommendation to the Central Government for Recognition/

withdrawal of recognition of dental qualifications awarded by dental

institutions in India and abroad.

d) Maintenance of Indian Dental Register by the concerned State Dental

Councils.

e) Grant of Eligibility Certificate to Indian Citizens and Overseas Citizen of

India going overseas for obtaining primary dental qualifications.

4. Constitution and Composition of Council

The Council is constituted by the Central Government under Section 3 of the

Dentists Act, 1948. The composition of the Council is laid down in Section 3 of

the Act. [http://dciindia.org.in/Dentistact1948.aspx].

5. Address

The Dental Council of India has its office at New Delhi and does not have any

subordinate office anywhere in India. The particulars are as under:-

Dental Council of India Aiwan-E-Galib Marg Kotla Road, New Delhi-110002

Tel.: 011-23236740, 23238542 Website: www.dciindia.org.in Email: secretary(&dciindia.orq


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Opening hours of the Office: 9:30 AM to 6:00 PM

Timings for Public Dealing: 11:00 to 5:00 PM

Working Days: Monday to Friday.


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CHAPTER -2

Powers and Duties of Officers and Employee

1. Dental Council of India

Dental Council of India is a Statutory Body incorporated under an Act of

Parliament viz. The Dentists Act, 1948 (XVI of 1948) to regulate the Dental

Education and the profession of Dentistry throughout India and it is financed

by the Govt. of India in the Ministry of Health & Family Welfare (Department

of Health) through Grant-in-aid. The General Body of the Dental Council of

India representing various State Governments, Universities, Dental Colleges,

Central Government, etc.

The Dental Council of India is the recommendatory body to the Central

Government for grant of permission for establishment of a dental college,

opening of a new or higher course of study, increase in in-take capacity at the

Under Graduate and Post Graduate level.

2. Powers and Duties of the Council

The Council in order to discharge of its functions is empowered to:

(i) Constitute Committees for general or special purposes at it

deems necessary to carry out the purposes of the Dentists Act;

(ii) appoint a Secretary who may also, if so decided by the Council,

act as Treasurer;

(iii) appoint such other officers and servants as the Council deems

necessary to enable it to carry out its functions under this Act;

(iv) Determine the conditions of the services of the employees.

The Council discharges its statutory functions and duties conferred upon it by

the Dentists Act.


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3. Powers and Duties of Employees

Section 8(1) of the Dentists Act, 1948 inter alia provides that the Council shall

(a) appoint a Secretary who may also, if so decided by the Council, act as

Treasurer; (b) appoint such other officers and servants as the Council deems

necessary to enable it to carry out its functions under this Act; (c) require and

take from the Secretary or from any other officer or servant such security for

the due performance of his duties as the Council considers necessary; and (d)

With the previous sanction of the Central Government, fix the fees and

allowances of the President Vice-President and other members of the Council,

and the pay and allowances and other conditions of service of officers and

servants of the Council.

Section 52 to 56 of the Regulations of the Dental Council of India, 1956

(as modified upto February, 1982) lays down the "powers and duties of

Secretary and other officers and servants of the Council". The provision reads

as under:-

"Secretary

52. The term of office of the Secretary shall be fixed by the Council

at the time of appointment. He shall normally retire on attaining the

age of superannuation as applicable to the Central Government

employees of the corresponding rank. Extension of service beyond the

date of superannuation may be granted by the Council in exceptional

cases on the recommendations of the Executive Committee but no

such extension shall be given without the prior approval of the

Government of India."

53. He shall perform such duties as have been given in the Act and

the Regulations. He shall also be responsible for the safety of the

property of the Council and the control and management of the office,

accounts and correspondence, and shall see that the office staff attend


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punctually, and generally fulfill all such duties as may be required of

him by the Council for the purposes of the Act. He shall attend and

the notes of the proceedings of meetings of the Council and Executive

Committee and any Sub-Committee.

The Secretary, shall not less than 90 days before the expiration of the

term of any existing appointment, draw the attention of the President

to the approaching vacancy, in order that a new appointment may be

made to take effect from the day on which the existing appointment

will expire.

Staff

54. Members of the Ministerial and non-ministerial staff and Class IV

servants shall retire on attaining the age of superanuation as applicable

to the Central Government employees of the corresponding rank.

Extention of service beyond the date of superanuation may be granted

by the Executive Committee in accordance with the Central

Government's general orders on the subject issued from time to time.

55. The powers and duties of the staff will be such as may be laid

down from time to time in the standing orders as framed for the

purpose by the Council.

56. (i) Subject to the approval of the President, the Secretary

shall appoint the ministerial staff and class IV servants and may

engage such temporary personnel as may be required from time

to time, and pay a reasonable rate of remuneration to such

personnel, provided it does not exceed the rate sanctioned by

the Central Government for corresponding permanent staff.

These appointments shall be subject to conformation by the

Executive Committee.


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(ii) The Council may, on the advice of the Executive

Committee, recommend to the Central Government to convert

any existing sanctioned temporary post of an officer, a member

of the ministerial staff or a class IV employees into a permanent

one after taking into account the volume of work of permanent

nature attached to the post and orders on the subject issued by

the Central Government from time to time and that the orders

of the Central Government in this respect shall be final."

The Secretary is assisted in the discharge of his duties, by officers in

the rank of Joint Secretary, Deputy Secretary, Law Officer, Accounts Officer,

Assistant Secretary, Section Incharge, Assistants and other staff in various

categories. The staff serves as the Secretariat of the Dental Council of India

and performs such duties as envisaged under the Dentist Act and the Rules

and Regulations made thereunder. The powers and duties of the staff will be

such as may be laid down from time to time in the standing orders as framed

for the purpose by the Council.


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CHAPTER -3

Procedure followed in decision making process, including channels of supervision and accountability

The Council constituted under Section 3 (Chapter II) of the Dentists Act is the

supreme decision making of the Organisation. The President, Vice-President,

Executive Committee of the Council is elected by the members of the Council from

amongst themselves.

Section 9 of the Dentists Act 1948 provides for the Executive Committee. The

Executive Committee consist of the President and Vice-President ex officio [and the

Director-General of Health Services ex officio] and five other members elected by the

Council. The Executive Committee in addition to the powers and duties conferred

upon it by the Dentists Act 1948, exercises and discharges such powers and duties

as the Council may confer or impose upon it by any regulations which may be made

in this behalf.

The decisions of the Council, Executive Committee and the Sub-Committee

are implemented by the Secretary through the respective sections of the Council

office. The work of the DCI is carried out through the following sections:-

(i) Administration (ii) Accounts (iii) Legal (iv) Under Graduate (v) Post Graduate (vi) Miscellaneous-I,II,III (vii) Inspection (viii) Computer/Admission (ix) Complaint Cell (x) Record (xi) Dairy & Dispatch (xii) Rn Section (xiii) Anti Ragging Cell


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The Secretary of the Council and other staffs are employed by the Council to

carry out the purposes of the Act. The Secretary is assisted in the discharge of its

functions & duties by officers & staffs as provided under Chapter 9 of this handbook.

On receipt of a proposal, the entry level staffs open up a file or process the

proposal in the existing file. The Section Officer/ Assistant scrutinize the proposal

with reference to the relevant Rules and place it before the Section Head/ Assistant

Secretary/ Deputy Secretary. The Assistant Secretary/ the Deputy Secretary review

the proposal and with his comments/observations places before the Secretary in

accordance with Office Orders. The Secretary decides the course of action to be

taken thereon, including placing the matter before the concerned Sub-Committee or

Executive Committee, with the approval of the President as and when required. The

respective superior officers have supervisory control over their subordinates.


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CHAPTER -4

The norms set by it for discharge of its functions

The Council in the performance of its functions is bound by the various Rules

and Regulations (refer Chapter 5 of this handbook) enacted under the Dentists Act,

1948.

L


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CHAPTER -5

The rules, regulations, instructions, manuals and records, held by it or under its control or used by its employees in

discharge of its functions

The following Dental Council of India Rules & Regulations is uploaded on DCI

website as per the specified links given under. It may be looked into on the official

website of Dental Council of India ww.dciindia.org.in.

1. The Dentists Act, 1948

2. The Dentists (Amendment) Act, 1993

3. Revised Dentists (Code of Ethics) Regulations, 2014

4. Dental Council (Election) Regulations, 1952

5. Dental Council of India Regulations, 1956

6. The Dentists (Amendment) Ordinance, 1992

7. Dental Council of India (Establishment of New Dental Colleges,

Opening of New or Higher Course of Study or Training and

Increase of Admission Capacity in Dental Colleges) Regulations,

2006 (alongwith Amendments)

8. Dental Council of India Revised BDS Course Regulations, 2007

(alongwith Amendments)

9. Dental Council of India Revised MDS Course Regulations, 2007


10. Dental Council of India Post Graduate Diploma Course

Regulations, 2008

11. Dental Council of India Post Graduate Diploma Course

Regulations (Dental Material), 2008

12. Dental Council of India Dental Hygienists Course Regulations,

2008

13. Dental Operating Room Asstt. Course Regulation,

2007(alongwith Amendments)


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14. Dental Council of India (Miscellaneous) Regulations, 2007

15. Dental Council of India Screening Test Regulations, 2009


16. Continuing Dental Education Regulations, 2007

17. DCI Regulations on Curbing the Menace of Ragging in Dental

Colleges, 2009


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CHAPTER -6

A statement of the categories of documents that are held by it or under its control

Scheme received by the Council for Establishment of Dental College for Opening a

New or Higher Course of Study or Training and Increase of Admission Capacity in

dental colleges.

Recommendations

Recommendations by the Council to the Government of India for Establishment of

Dental College for Opening a New or Higher Course of Study or Training and

Increase of Admission Capacity in any dental college.

Recommendation made by the Council to the Central Government for inclusion of a

dental qualification in the Schedules of the Dentists Act 1948.

Eligibility Certificates

Application made by the students/candidates and record of communication with the

concerned authorities.

Staff Related

Employment Record of the Employees

Admission

List of students admitted in Dental Institutions approved/recognised by Dental Council of India.

Issuance of NOC


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CHAPTER -7

The particulars of any arrangement that exists for consultation with, or representation by, the members of the public in relation to the formulation of its policy or implementation thereof

The Council offers services primarily for the dental colleges and Dental professionals.

There is no direct interaction with the public at any point of time. Therefore, at times

meetings with Stakeholders are organized. The Secretary meets visitors only with

prior appointment during the visiting hours.


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CHAPTER -8

Council constituted under Section 3 of the Dentists Act, 1948

1. Council Members

[http://dciindia.org.in/CouncilMember.aspx]

2. Executive Committee Members

[http://dciindia.org.in/ExecutiveCommitteeMembers.aspx]

3. Ex-Officio Member U/S 3(g) of the Dentists Act

[http://dciindia.org.in/CouncilMember.aspx?id=g]

4. Other Committees.

Note: - Information as regards above is available on DCI website as per the specified links.


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CHAPTER - 9

A directory of its officers and employees and their monthly remuneration received by each of its officers and employees, including the system of compensation as provided in its regulations

The Council offers Central Government salary with other allowances as per Government directions. Council does not provide residential accommodation.

S. No. Name of Official Designation Pay Band Grade Pay

1. Shri M.L. Meena (Secretary I/c)

Joint Secretary (Legal & Administration)

37,400-67,000 8,700

2. Shri S.S. Kanyal Deputy Secretary 15,600-39,100 7,600

3. Shri Praveen Dewan Assistant Secretary 15,600-39,100 6,600

4. Shri Satya Prakash Assistant Secretary 15,600-39,100 6,600

5. Shri Dharam Pal Assistant Secretary 15,600-39,100 6,600

6. Smt. Alka Mehta Assistant Secretary 15,600-39,100 6,600

7. Shri Mukesh Kumar Assistant Secretary 15,600-39,100 6,600

8. Shri Puneet Bansal Accounts Officer 15,600-39,100 6,600

9. Shri Dewanand T. Kumbhare

Section Officer 9,300-34,800 5,400

10. Shri Vinay Gupta Section Officer 9,300-34,800 5,400

11. Shri Anil Kumar Section Officer 9,300-34,800 5,400

12. Smt. Kamini Uppal Section Officer 9,300-34,800 5,400

13. Smt. Praveen Budhiraja

Section Officer 9,300-34,800 4,800

14. Smt. Kusum Section Officer 9,300-34,800 4,800

15. Smt. Kiran Makkar Section Officer 9,300-34,800 4,800

16. Shri Azad Singh Mathur

Assistant 9,300-34,800 4,600

17. Shri Govind Ram Assistant 9,300-34,800 4,600


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18. Shri Naveen Sharma Assistant 9,300-34,800 4,600

19. Smt. Savita Assistant 9,300-34,800 4,600

20. Shri Ram Gahan Prajapati

Assistant 9,300-34,800 4,600

21. Shri Mohinder Singh Assistant 9,300-34,800 4,600

22. Smt. Deepa Chauhan

Assistant 9,300-34,800 4,600

23. Shri Madan Lal U.D. Clerk 5,200-20,200 2,400

24. Shri Mangal Sain U.D. Clerk 5,200-20,200 2,400

25. Shri Indra Raj U.D. Clerk 5,200-20,200 2,400

26. Shri Rakesh Kumar U.D. Clerk 5,200-20,200 2,400

27. Shri Gaurav Dixit U.D. Clerk 5,200-20,200 2,400

28. Shri Sanjay Kumar U.D. Clerk 5,200-20,200 2,400

29. Shri Yogesh Kumar Bhorwal

U.D. Clerk 5,200-20,200 2,400

30. Smt. Jyoti U.D. Clerk 5,200-20,200 2,400

31. Shri Pramod Kumar U.D. Clerk 5,200-20,200 2,400

32. Shri Prem Chand Kargati

L.D. Clerk 5,200-20,200 1,900

33. Shri Avinash Chhabbarwal

L.D. Clerk 5,200-20,200 1,900

34. Shri Piyush Tanwar L.D. Clerk 5,200-20,200 1,900

35. Shri Umesh Singh Bisht

L.D. Clerk 5,200-20,200 1,900

36. Shri Sachin Gupta L.D. Clerk 5,200-20,200 1,900

37. Shri Sant Lal Gupta L.D. Clerk 5,200-20,200 1,900

38. Shri Ram Chander Pandey

L.D. Clerk 5,200-20,200 1,900

39. Shri Dhiraj Singh L.D. Clerk 5,200-20,200 1,900

40. Shri Punit Kumar Staff Car Driver 5,200-20,200 1,900


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41. Shri Bikky Kumar Staff Car Driver 5,200-20,200 1,900

42. Shri Vimal Kumar Gestetner Operator 5,200-20,200 1,900

43. Shri Virender Kumar Daftari 5,200-20,200 1,800

44. Shri Dharmender Peon 5,200-20,200 1,800

45. Shri Pintu Safai Karamchari 5,200-20,200 1,800

46. Shri Sunil Safai Karamchari 5,200-20,200 1,800


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CHAPTER -10

The budget allocated to each of its agency, indicating the particulars of all plans, proposed expenditure and reports on disbursements made and etc.

To obtain this information from accounts


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CHAPTER -11

Particulars of recipients of concessions, permits or authorization granted by the Public Authority

The Dental Council of India is the recommendatory body to the Central

Government u/s 10A of the Dentists Act, 1948 for grant of letter of permission for

the establishment of dental college, increase of intake capacity, opening of a new or

higher course of study, renewal of permission. Such records are maintained in the

concerned file of the college by the respective Section.

The details of number of registered dentists are maintained by the Misc.

Section-II, as per data or information received from the respective State Dental

Councils.

The grant of Eligibility Certificate to Indian Citizen/OCI interested to pursue

foreign dental qualification is maintained by the Misc. Section-I.


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CHAPTER -12

Details in respect of the information, available to or held by it, reduced in an electronic form

Information relating to the Dental Colleges imparting UG & PG dental courses along with admission capacity. [http://dciindia.org .in/CollegeSearch.aspx?ColName=&CourseId =&SplId=O&StateId =&Hospital=&Type=0&Status=--Select--]

Details of Council Members [http://dciindia.org.in/CouncilMemberaspx]

Details of Executive Committee Members [http://dciindia.org.in/ExecutiveCommitteeMembers.aspx]

Details of Ex-Officio Member U/S 3(g) of the Dentists Act [http://dciindia.org.in/CouncilMemberaspx?id=g]

List of students submitted by the colleges [http://dciindia.org.in/StudentDetailsList.aspx]

List of Act & Regulations [http://dciindia.org.in/Dentistact1948.aspx]


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CHAPTER -13

The names, desicinations and other particulars of the Public Information Officers

The following officers are as on date the First Appellate Authority and Public Information Officer of the Dental Council of India under Section 5(1) and under Section 19(1) of Right to Information Act, 2005:

Name with Designation Ph. (Office) & Email

Detail of First Appellate Authority of DCI in respect of RTI Act 2005

Dr. Dibyendu Mazumder President Dental Council of India Aiwan-E-Galib Marg Kotla Road, New Delhi-110002

011-23236740 011-23238542 email:[email protected]

Detail of Public Information Officer of DCI in respect of RTI Act 2005

Mrs. Alka Mehta Assistant Secretary Dental Council of India Aiwan-E-Galib Marg Kotla Road, New Delhi-110002

011-23236740 011-23238542 email:[email protected]

Note: The fee under RTI Act, if paid through Indian Postal Order/Demand Draft should be in favour of the Secretary, Dental Council of India, payable at New Delhi.


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CHAPTER -14

The particulars of facilities available to citizens for obtaining information, including the working hours of a library or reading room, if maintained for public use

1. During, the public dealing hours [11:00 AM to 5:00 PM] on official working

days applicants/ citizens can visit to obtain information.

2. Information on other matters can be obtained from the Public Information

Officer, designated under Rn Act.

3. The Council's Library is meant for the Council's Employees only.


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1214 GI/2016 (1)

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2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART III —SEC. 4]

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,e- ,y- ehuk] izHkkjh lfpo [foKkiu&III@4@vlk-@395(98)]


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vkSj nar dkystksa dh nkf[kyk {kerk c<+kus½ ls lacaf/kr fofu;e] 2006 tks Hkkjr ds vlk/kkj.k jkti= ds Hkkx III, [kaM 4 esa 12-01-2006 dks izdkf'kr fd, x, FksA

2- eq[; fofu;e dk igyk la'kks/ku tks Hkkjr ds vlk/kkj.k jkti= ds Hkkx III, [kaM 4 esa 16-01-2006 dks izdkf'kr fd, x, FksA

3- eq[; fofu;e dk nwljk la'kks/ku tks Hkkjr ds vlk/kkj.k jkti= ds Hkkx III, [kaM 4 esa 22-02-2006 dks izdkf'kr fd, x, FksA

4- eq[; fofu;e dk rhljk la'kks/ku tks Hkkjr ds vlk/kkj.k jkti= ds Hkkx III, [kaM 4 esa 02-11-2006 dks izdkf'kr fd, x, FksA

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DENTAL COUNCIL OF INDIA

NOTIFICATION

New Delhi, the 7th March, 2016

No. DE-218-2016.—In exercise of the powers conferred by Section 10A read with Section 20 of the

Dentists Act, 1948 (16 of 1948), the Dental Council of India, on the recommendation of DGHS pursuant to

the direction of the Hon’ble Supreme Court in its order dated 24.03.2015 in W.P. No. 76/2015 for framing

Time Schedule, with the previous approval of the Central Government, hereby amend the Principal

Regulations, namely, “Dental Council of India (Establishment of New Dental Colleges, Opening of New or

Higher Course of Study or Training and Increase of Admission Capacity in Dental Colleges) Regulations,

2006” as under:-

1. Short title and commencement:-

(iii) These Regulations may be called the “Dental Council of India (Establishment of New Dental

Colleges, Opening of New of Higher Course of Study or Training and Increase of Admission

Capacity in Dental Colleges) (8th Amendment) Regulations, 2016”.

(iv) They shall come into force from the date of their publication in the Official Gazette.

2. In regulation 4(2) of the principal DCI regulations 2006, the existing ‘Schedule’ inserted by “Dental

Council of India (Establishment of New Dental Colleges, Opening of New of Higher Course of Study

or Training and Increase of Admission Capacity in Dental Colleges) (1st Amendment) Regulations,

2006”, notified in the Official Gazette on 16.01.2006 is hereby deleted and substituted with the

following new schedule:-

“SCHEDULE”

[See Regulation 4(2)]

TIME SCHEDULE FOR RECEIPT OF APPLICATION FOR ESTABLISHMENT OF NEW

DENTAL COLLEGES / INCREASE OF UNDER GRADUATE SEATS / RENEWAL OF

PERMISSION AND PROCESSING OF THE APPLICATIONS BY THE CENTRAL GOVERNMENT

AND THE DENTAL COUNCIL OF INDIA.

Sl. No. Stage of processing Last Date

1. Receipt of applications by the Central Government. Between 15th June to 7th July (both

days inclusive) of any year

2. Forwarding of applications by the Central Government to

Dental Council of India.

By 31st July


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4 THE GAZETTE OF INDIA : EXTRAORDINARY [PART III —SEC. 4]

3. Technical Scrutiny, Assessment and Recommendations by

the Dental Council of India.

By 31st December

4. Receipt of reply/compliance from the applicant by the

Central Government and for personal hearing thereto, if any

and forwarding of compliance by the Central Government to

the Dental Council of India.

Two months from receipt of

recommendation from DCI but

not after 31st January.

5. Final recommendations by the Dental Council of India. By 30th April

6. Issue of Letter of Permission by the Central Government. By 31st May

7. Commencement of academic session/term 1st of August

8. Last date upto which students can be admitted/Joined

against stray vacancies arising due to any reason

By 15th September

Note:

(1) In case of renewal permission, the applicants shall submit the application to the Dental Council of

India by 31st July.

(2) The time schedule indicated above may be modified by the Central Government, for reasons to be

recorded in writing, in respect of any class or category of applications.

TIME SCHEDULE FOR RECEIPT OF APPLICATION FOR OPENING OF HIGHER COURSES OF

STUDY / INCREASE OF POST GRADUATE SEATS / RENEWAL OF PERMISSION AND

PROCESSING OF THE APPLICATIONS BY THE CENTRAL GOVERNMENT AND THE DENTAL

COUNCIL OF INDIA.

Sl.

No.

Stage of processing Last Date

1. Receipt of applications by the Central Government. Between 15th March to 7

th April

(both days inclusive of any year)

2. Forwarding of applications by the Central Government to


By 30th April

3. Technical Scrutiny, Assessment and Recommendations by the


By 15th October

4. Receipt of reply/ compliance from the applicant by the Central

Government and for personal hearing thereto, if any and

forwarding of compliance by the Central Government to the


Two months from receipt of

recommendation from DCI but

not after 15th November

5. Final recommendations by the Dental Council of India. By 31st January

6. Issue of Letter of Permission by the Central Government. By 28th February

7. Commencement of academic session/term 1st May

8. Last date upto which students can be admitted/Joined against

stray vacancies arising due to any reason

By 31st May

Note:

(1) In case of renewal permission, the applicants shall submit the application to the Dental Council of

India by 30th April.

(2) The time schedule indicated above may be modified by the Central Government, for reasons to be

recorded in writing, in respect of any class or category of applications.

M. L. MEENA, Secy. I/c

[ADVT.III/4/Exty./395(98)]


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¹Hkkx IIIµ[k.M 4º Hkkjr dk jkti=k % vlk/kj.k 5

Foot note:

1. The Principal Regulations, namely, the Dental Council of India (Establishment of New Dental Colleges,

Opening of New of Higher Course of Study or Training and Increase of Admission Capacity in Dental

Colleges) Regulations, 2006, published in Part III, Section 4 of the Gazette of India, Extraordinary, on

12.01.2006.

2. The 1st Amendment of the Principal Regulations, published in Part III, Section 4 of the Gazette of India,

Extraordinary, on 16.01.2006.

3. The 2nd

Amendment of the Principal Regulations, published in Part III, Section 4 of the Gazette of

India, Extraordinary, on 22.02.2006.

4. The 3rd

Amendment of the Principal Regulations, published in Part III, Section 4 of the Gazette of India,


5. The 4th Amendment of the Principal Regulations, published in Part III, Section 4 of the Gazette of India,


Uploaded by Dte. of Printing at Government of India Press, Ring Road, Mayapuri, New Delhi-110064

and Published by the Controller of Publications, Delhi-110054.


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Dengue and Chikungunya


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What is Dengue?

• Dengue (pronounced den' gee)

is a viral disease.

• Dengue can be caused by infection with any

one of four closely related dengue viruses.

• DENV 1, DENV 2, DENV 3 or DENV 4.


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How does it spread?

The dengue viruses are transmitted to humans

by the bite of an infected Aedes mosquito.


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• One distinct physical

feature (black and

white stripes on its

body and legs)

hence also called as

‘Tiger mosquito’.

• Bites during the day.

• Lays its eggs in

clean, stagnant

water.

Characteristics of the

Aedes Mosquito


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Did you know?

• Only the female Aedes mosquito bites as it needs the

protein in blood to develop its eggs.

• The mosquito becomes infective approximately

seven days after it has bitten a person carrying the

virus.

• Once infected, a mosquito remains infective for life

and passes on the virus to the eggs it lays.

• Peak biting time is at dawn and dusk – 2 hours after

sunrise and 2 hours before sunset.


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Aedes mosquito: Fast facts

• The average lifespan of an Aedes mosquito is

2 weeks.

• The mosquito can lay eggs about 3 times in

its lifetime, and about 100 eggs are produced

each time.

• The eggs can withstand very dry conditions

(desiccation) and remain viable for many

months in the absence of water.

– Repopulation will occur as soon as the eggs in the

containers are flooded with water.


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Aedes mosquito: Fast facts (contd.)

• Adult mosquitoes “usually” rests indoors in dark

areas (closets, under beds, behind curtains).

• They have limited flight range – can fly an average of

400metres looking for water-filled containers to lay

their eggs. This means that people, rather than

mosquitoes, rapidly move the virus within and

between communities and places.

• A few mosquitoes per household can produce large

dengue outbreaks. The dengue mosquito does not

lay eggs in ditches, drainages, canals, wetlands,

rivers or lakes.


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• The mosquito life cycle, from egg to larvae, pupae, and

to an adult mosquito, takes 8 days and occurs in water.

• Humans develops disease after 5 – 6 days of being bitten

by an infective mosquito.


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What can you do to reduce risk of

acquiring dengue?

PROTECT YOURSELF FROM MOSQUITO BITES

• Dengue mosquitoes bite during the day time. Highest

biting intensity is about 2 hours after sunrise and

before sunset.

• Wear full sleeves clothes and long dresses to cover as

much of your body as possible.

• Use repellents, mosquito coils, electric vapor mats

during the daytime also to prevent dengue.

• Use mosquito nets to protect children, elderly and

others who may rest during the day.


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Clinical description :

Dengue fever (classical)

An acute onset high fever of 2-7 days duration with

2 or more of the following manifestations:

Headache (often severe)

Retro-orbital pain (severe eye pain behind eyes)

Myalgia (muscle pain)

Arthralgia (joint pain)

Rash

Hemorrhagic manifestations: nose or gum bleed,

easy bruising

All the above symptoms and signs may not be present in the patient.


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What to do if you think you have

dengue

Bed rest- acute phase

Cold sponging for reducing fever

X Avoid aspirin, brufen etc – these can cause gastritis,

vomiting, platelet dysfunction

Paracetamol is preferable for fever management.

Oral electrolyte therapy: for excessive sweating,

vomiting

• Avoid mosquito bites

– wear full sleeves; Place patient under bed net or

use insect repellent on the patient while they have

a fever, Put screens on windows and doors to

prevent mosquitoes from coming into house.

• Consult a physician.

TAKE PLENTY OF FLUIDS


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Laboratory findings in

dengue: Blood picture

• If a patient is suspected to be having dengue,

the doctor may ask the patient to get a blood

test done.

• Findings such as reduced platelets or an

increase in blood haematocrit makes

dengue more likely.

(Platelets are cells in blood that help to stop bleeding.

Haematocrit indicates the thickness of blood).


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Dengue specific Tests

• Dengue specific tests done in a blood sample

can confirm a diagnosis of dengue.

• There are two basic types of tests:

1. Detecting Dengue antigen in

blood( within first 5 days of

onset of symptoms): NS1

antigen based assays

2. Detecting Dengue antibodies

in blood( after first 5 days of

onset of symptoms)


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Most people who suffer from

dengue fever recover in

1–2 weeks time.


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PREVENT DEHYDRATION

• Dehydration can occur when a person loses too much

fluid (from high fevers, vomiting, or poor oral intake).

• Give plenty of fluids- ORS and juices are preferable to

water

• Watch for any signs of dehydration

Decrease in urination

Few or no tears when child cries

Dry mouth, tongue or lips

Sunken eyes

Listlessness or overly agitated or confused

Fast heart beat (more than 100/min)

Cold or clammy fingers and toes


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The critical period may be

after 3-5 days of fever

• In a few patients, the smallest blood

vessels (capillaries) may become excessively

permeable (“leaky”), allowing the fluid

component to escape from the blood

vessels into body cavities.

• This may lead to failure of the circulatory

system and shock if properly not managed

with fluid resuscitation.


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Can people die from dengue fever?

• People who suffer from dengue fever have no risk of death

but rarely some of them may develop Dengue Hemorrhagic

Fever (DHF) or Dengue Shock Syndrome(DSS).

• Patients suspected to be suffering from DHF/DSS should be

admitted to a hospital without delay.

• Infants and young children are more likely than adults to

develop DHF/DSS or manifestations of severe clinical illness.

Parents need to be vigilant.

• With proper treatment, the patients with Dengue

hemorrhagic fever and dengue shock syndrome can

recover fully.

– Good treatment provided in time can save lives.


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Warning signs

Immediate medical attention !

Severe abdominal pain or persistent vomiting

Red spots or patches on the skin

Bleeding from nose or gums

Vomiting blood

Black, tarry stools (feces, excrement)

Drowsiness or irritability

Pale, cold, or clammy skin

Difficulty in breathing


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What does the treating doctor

need to do in such cases?

Monitor progress of patients regularly at 1-2

hours interval.

Platelet counts and haematocrit need to be

monitored repeatedly to review the progress

of patients.

The doctor may advise IV fluids or platelet

transfusion.

All patients do not require platelet

transfusion.


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Can you get dengue again

after suffering from it once?

YES

• If a person has suffered from one virus, there can be a

repeat occurrence of dengue if a different strain is

involved subsequently.

• Being affected by one strain offers no protection

against the others.

• A person could suffer from dengue more than once in

her/his lifetime.


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Can people suffer from

dengue and not appear ill?

YES

• There are many people who are infected

with the virus and do not suffer from any

signs or symptoms of the disease.

• For every patient with symptoms and

signs there may be 4-5 persons with no

symptoms or with very mild symptoms.


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Can dengue fever patient be treated

at home?

• Most patients with dengue fever can be

treated at home.

• They should take rest, drink plenty of fluids that

are available at home and eat nutritious diet.

• Whenever available, Oral Rehydration Salt/ORS

(commonly used in treating diarrhea) is

preferable. Fruit juices are also good.

• It is important to look for danger signs and

contact the doctor as soon as any one or more

of these are found.


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What is Chikungunya ?

• Chikungunya is a viral illness spread by bite

of infected mosquitoes and clinically

resembles dengue fever.

• The name comes from the African language

meaning “that which bends up”and aptly

describes the stooped appearance of

sufferers with joint pain due to the disease.


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How does Chikungunya spread?

• Through bite of female infected mosquitoes Aedes

aegypti and Aedes albopictus.

• Mosquito usually transmits the disease by biting an

infected person and then biting someone else.

– An infected person cannot spread the infection

directly to other persons (i.e. it is not a

contagious disease).

• Aedes aegypti mosquitoes bite during the day time.

They breed in anything that holds clean water

including tyres, coconut shells, flower pots, storage

pans and cooling systems.


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Chikungunya

Clinical signs and Symptoms

• Typical symptoms are similar to that of dengue:

sudden onset fever, severe headache, chills, nausea

and vomiting, and severe joint pains.

• Most patients recover fully, but in some cases the

joint pains may persist for weeks or months.

• Children less than 1 year and elderly are at greater

risk of severe disease

– Underlying medical conditions have also been

identified as a risk factor for poor disease

outcome.


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Chikungunya

Management of patient

• Chikungunya is diagnosed by blood tests (ELISA).

• Symptomatic management

– adequate rest; medicines to reduce joint pains

and fever. Some patients may require long term

pain management medication.

• Patients should avoid further mosquito exposure,

either by staying in places with screens or by using

mosquito nets.


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Prevention and control are entirely dependent on taking

steps to avoid mosquito bites and eliminating mosquito

breeding sites.


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Prevent mosquito breeding

•Discard/ Destroy unused items.

•Drain out water from various containers.

•Regularly change water and clean flower vases and

other items.

•Empty coolers.

•Cover water storage containers.


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To stop or to slow down the dengue transmission "thermal

fogging", using fogging machines is a supplemental

measure.

In fogging, we should use an insecticide that has an

immediate knock-down effect on adult mosquitoes.


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Individual and household

protection

• Wear full sleeves and full-length clothes to cover limbs.

• Repellents may be applied to exposed skin or to clothing,

in strict accordance with label instructions.

• Insecticide-treated mosquito nets afford good protection

for those who sleep during the day (e.g. infants, elderly).

• Household insecticide aerosol products, mosquito coils or

insecticide vaporizers may also reduce biting activity.

• Household fixtures such as window and door screens and

air-conditioning can also reduce biting.


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Controlling Dengue and

Chikungunya is everyone’s

responsibility.


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International Association of Dental Traumatology

DENTAL TRAUMA GUIDELINES

Revised 2012

CONTENT: Section 1. Fractures and luxations of permanent teeth Section 2. Avulsion of permanent teeth Section 3. Traumatic injuries to primary teeth Disclaimer: These guidelines are intended to provide information for health care providers caring for patients with dental injuries. They represent the current best evidence based on literature research and professional opinion. As is true for all guidelines, the health care provider must apply clinical judgment dictated by the conditions present in the given traumatic situation. The IADT does not guarantee favorable outcomes from following the Guidelines, but using the recommended procedures can maximize the chances of success.

THESE GUIDELINES ARE ENDORSED BY THE AMERICAN ASSOCIATION OF ENDODONTISTS


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INTRODUCTION Traumatic dental injuries (TDIs) occur frequently in children and young adults, comprising 5% of all injuries. Twenty‐five percent of all school children experience dental trauma and 33% of adults have experienced trauma to the permanent dentition, with the majority of the injuries occurring before age 19. Luxation injuries are the most common TDIs in the primary dentition, whereas crown fractures are more commonly reported for the permanent teeth. Proper diagnosis, treatment planning and follow‐up are important to assure a favorable outcome. This update includes a review of the current dental literature using EMBASE, MEDLINE, PUBMED and Scopes searches from 1996‐2011, as well as a search of Dental Traumatology from 2000‐2011. The goal of these guidelines is to provide information for the immediate and urgent care of TDIs. It is understood that some of the subsequent treatment may require secondary and tertiary interventions involving specialists with experience in dental trauma. The IADT published its first set of guidelines in 2001, and updated them in 2007. As with previous guidelines, the working group included experienced investigators and clinicians from various dental specialties and general practice. The current revision represents the best evidence based on the available literature and expert professional judgment. In cases where the data did not appear conclusive, recommendations are based on the consensus opinion of the working group, followed by review by the members of the IADT Board of Directors.

It is understood that guidelines are to be applied with evaluation of the specific clinical circumstances, clinicians’ judgment and patients’ characteristics, including but not limited to compliance, finances and understanding of the immediate and long‐term outcomes of treatment alternatives versus non‐treatment. The IADT cannot and does not guarantee favorable outcomes from adherence to the Guidelines, but believe that their application can maximize the chances of a favorable outcome. These Guidelines offer recommendations for diagnosis and treatment of specific TDIs; however, they provide neither the comprehensive nor the detailed information found in textbooks, in the scientific literature, and most recently in the Dental Trauma Guide (DTG), which can be accessed @ http://www.dentaltraumaguide.org and the IADT website, http://www.iadt‐dentaltrauma.org provides connection to the journal Dental Traumatology and other dental trauma information.

GENERAL RECOMMENDATIONS Special considerations for trauma to primary teeth A young child is often difficult to examine and treat due to lack of cooperation and because of fear. The situation is distressing for both the child and the parents. It is important to keep in mind that there is a close relationship between the apex of the root of the injured primary tooth, and the underlying permanent tooth germ. Tooth malformation, impacted teeth, and eruption disturbances in the developing permanent dentition are some of the consequences that can occur following severe injuries to primary teeth and/or alveolar bone. A child’s maturity and ability to cope with the emergency situation, the time for shedding of the injured tooth and the occlusion, are all important factors that influence treatment. Repeated trauma episodes are frequent in children. Immature versus Mature Permanent Teeth


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Every effort should be made to preserve pulpal vitality in the immature permanent tooth to ensure continuous root development. The vast majority of TDIs occur in children and teenagers where loss of a tooth has lifetime consequences. The immature permanent tooth has considerable capacity for healing after traumatic pulp exposure, luxation injury and root fractures. Avulsion of Permanent Teeth The prognosis for avulsed permanent teeth is very much dependent on the actions taken at the place of accident. Promotion of public awareness of first‐aid treatment for the avulsed tooth is strongly encouraged. Treatment choices and prognosis for the avulsed tooth are largely dependent on the vitality of the periodontal ligament (PDL), and the maturity of the root. Patient/Parent Instructions

Patient compliance with follow‐up visits and home care contributes to better healing following a TDI. Both the patients and the parents of young patients should be advised regarding care of the injured tooth/teeth for optimal healing, prevention of further injury by avoidance of participation in contact sports, meticulous oral hygiene, and rinsing with an antibacterial such as Chlorhexidine Gluconate 0.1% alcohol free for 1‐2 weeks. Alternatively, with a young child, it is desirable to apply Chlorhexidine Gluconate to the affected area with a cotton swab. The use of pacifiers should be restricted.


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FRACTURES AND LUXATIONS OF PERMANENT TEETH 1. Treatment guidelines for fractures of teeth and alveolar bone Followup Procedures

for fractures of teeth and alveolar bone+

Favorable and Unfavorable outcomes include some, but not necessarily all, of the

following: INFRACTION

Clinical findings Radiographic findings

Treatment

Follow-Up

Favorable Outcome

Unfavorable Outcome

● An incomplete fracture (crack) of the enamel without loss of tooth structure. ● Not tender. If tenderness is observed evaluate the tooth for a possible luxation injury or a root fracture.

● No radiographic abnormalities. ● Radiographs recommended: a periapical view. Additional radiographs are indicated if other signs or symptoms are present.

● In case of marked infractions, etching and sealing with resin to prevent discoloration of the infraction lines. Otherwise, no treatment is necessary.

● No follow-up is generally needed for infraction injuries unless they are associated with a luxation injury or other fracture types.

● Asymptomatic ● Positive response to pulp testing. ● Continuing root development in immature teeth.

● Symptomatic ● Negative response to pulp testing. ● Signs of apical periodontitis. ● No continuing root development in immature teeth. ● Endodontic therapy appropriate for stage of root development is indicated.

ENAMEL FRACTURE Clinical findings

Radiographic findings

Treatment

Followup

Favorable Outcome

Unfavorable Outcome

● A complete fracture of the enamel. ● Loss of enamel. No visible sign of exposed dentin. ● Not tender. If tenderness is observed evaluate the tooth for a possible luxation or root fracture injury. ● Normal mobility. ● Sensibility pulp test usually positive.

● Enamel loss is visible. ● Radiographs recom-mended: periapical, occlusal and eccentric exposures. They are recommended in order to rule out the possible presence of a root fracture or a luxation injury. ● Radiograph of lip or cheek to search for tooth fragments or foreign materials.

● If the tooth fragment is available, it can be bonded to the tooth. ● Contouring or restoration with composite resin depending on the extent and location of the fracture.

6-8 weeks C++ 1 year C++

● Asymptomatic ● Positive response to pulp testing. ● Continuing root development in immature teeth. ● Continue to next evaluation.

● Symptomatic ● Negative response to pulp testing. ● Signs of apical periodontitis ● No continuing root development in immature teeth. ● Endodontic therapy appropriate for stage of root development is indicated.

+ = for crown fractured teeth with concomitant luxation injury, use the luxation followup schedule. C++ = clinical and radiographic examination. Vol. 1 Issue 11 L.E.D. E-Journal

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Follow-Up Procedures for fractures of teeth and alveolar bone+


following: ENAMEL-DENTIN-

FRACTURE Clinical findings


Treatment

Follow-Up

Favorable Outcome

Unfavorable Outcome

● A fracture confined to enamel and dentin with loss of tooth structure, but not exposing the pulp. ● Percussion test: not tender. If tenderness is observed, evaluate the tooth for possible luxation or root fracture injury. ● Normal mobility. ● Sensibility pulp test usually positive.

● Enamel-dentin loss is visible. ● Radiographs recom-mended: periapical, occlusal and eccentric exposure to rule out tooth displacement or possible presence of root fracture. ● Radiograph of lip or cheek lacerations to search for tooth fragments or foreign materials.

● If a tooth fragment is available, it can be bonded to the tooth. Otherwise perform a provisional treatment by covering the exposed dentin with glass- Ionomer or a more permanent restoration using a bonding agent and composite resin, or other accepted dental restorative materials ● If the exposed dentin is within 0.5mm of the pulp (pink, no bleeding) place calcium hydroxide base and cover with a material such as a glass ionomer.


● Asymptomatic ● Positive response to pulp testing. ● Continuing root development in immature teeth ● Continue to next evaluation


ENAMEL-DENTIN-PULP FRACTURE

Clinical findings


Treatment

Favorable Outcome

Unfavorable Outcome

● A fracture involving enamel and dentin with loss of tooth structure and exposure of the pulp. ● Normal mobility ● Percussion test: not tender. If tenderness is observed, evaluate for possible luxation or root fracture injury. ● Exposed pulp sensitive to stimuli.

● Enamel – dentin loss visible. ● Radiographs recommended: periapical, occlusal and eccentric exposures, to rule out tooth displacement or possible presence of root fracture. ● Radiograph of lip or cheek lacerations to search for tooth fragments or foreign materials.

● In young patients with immature, still developing teeth, it is advantageous to preserve pulp vitality by pulp capping or partial pulpotomy. Also, this treatment is the choice in young patients with completely formed teeth. ● Calcium hydroxide is a suitable material to be placed on the pulp wound in such procedures. ● In patients with mature apical development, root canal treatment is usually the treatment of choice, although pulp capping or partial pulpotomy also may be selected. ● If tooth fragment is available, it can be bonded to the tooth. ● Future treatment for the fractured crown may be restoration with other accepted dental restorative materials.


● Asymptomatic. ● Positive response to pulp testing. ● Continuing root development in immature teeth. ● Continue to next evaluation.

● Symptomatic. ● Negative response to pulp testing. ● Signs of apical periodontitis. ● No continuing root development in immature teeth. ● Endodontic therapy appropriate for stage of root development is indicated.

+ = for crown fractured teeth with concomitant luxation injury, use the luxation followup schedule C++ = clinical and radiographic examination. Vol. 1 Issue 11 L.E.D. E-Journal

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Follow-Up Procedures for fractures of teeth and alveolar bone +


following: CROWN-ROOT

FRACTURE WITHOUT PULP EXPOSURE

Clinical findings


Treatment

Follow-Up

Favorable Outcome

Unfavorable Outcome

● A fracture involving enamel, dentin and cementum with loss of tooth structure, but not exposing the pulp. ● Crown fracture extending below gingival margin. ● Percussion test: Tender. ● Coronal fragment mobile. ● Sensibility pulp test usually positive for apical fragment.

● Apical extension of fracture usually not visible. ● Radiographs recommended: periapical, occlusal and eccentric exposures. They are recommended in order to detect fracture lines in the root.

Emergency treatment ● As an emergency treatment a temporary stabilization of the loose segment to adjacent teeth can be performed until a definitive treatment plan is made. Non-Emergency Treatment Alternatives Fragment removal only ● Removal of the coronal crown-root fragment and subsequent restoration of the apical fragment exposed above the gingival level. Fragment removal and gingivectomy (sometimes ostectomy) ● Removal of the coronal crown-root segment with subsequent endodontic treatment and restoration with a post-retained crown. This procedure should be preceded by a gingivectomy, and sometimes ostectomy with osteoplasty. Orthodontic extrusion of apical fragment ● Removal of the coronal segment with subsequent endodontic treatment and orthodontic extrusion of the remaining root with sufficient length after extrusion to support a post-retained crown. Surgical extrusion ● Removal of the mobile fractured fragment with subsequent surgical repositioning of the root in a more coronal position. Root submergence ● Implant solution is planned. Extraction ● Extraction with immediate or delayed implant-retained crown restoration or a conventional bridge. Extraction is inevitable in crown-root fractures with a severe apical extension, the extreme being a vertical fracture.

6-8 weeks C++

1 year C++



+=for crown fractured teeth with concomitant luxation injury, use the luxation followup schedule. C++ =clinical and radiographic examination


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Follow-Up Procedures for fractures of teeth and alveolar bone +


following: CROWN-ROOT

FRACTURE WITH PULP EXPOSURE

Clinical findings


Treatment

Follow-Up

Favorable Outcome

Unfavorable Outcome

● A fracture involving enamel, dentin, and cementum and exposing the pulp. ● Percussion test: tender. ● Coronal fragment mobile.

● Apical extension of fracture usually not visible. ● Radiographs recommended: periapical and occlusal exposure.

Emergency treatment ● As an emergency treatment a temporary stabilization of the loose segment to adjacent teeth. ● In patients with open apices, it is advantageous to preserve pulp vitality by a partial pulpotomy. This treatment is also the choice in young patients with completely formed teeth. Calcium hydroxide compounds are suitable pulp capping materials. In patients with mature apical development, root canal treatment can be the treatment of choice. Non-Emergency Treatment Alternatives ● Fragment removal and gingivectomy (sometimes ostectomy) Removal of the coronal fragment with subsequent endodontic treatment and restoration with a post-retained crown. This procedure should be preceded by a gingivectomy and sometimes ostectomy with osteoplasty. This treatment option is only indicated in crown-root fractures with palatal subgingival extension. ● Orthodontic extrusion of apical fragment Removal of the coronal segment with subsequent endodontic treatment and orthodontic extrusion of the remaining root with sufficient length after extrusion to support a post-retained crown. ● Surgical extrusion Removal of the mobile fractured fragment with subsequent surgical repositioning of the root in a more coronal position. ●Root submergence An implant solution is planned, the root fragment may be left in situ. ●Extraction Extraction with immediate or delayed implant-retained crown restoration or a conventional bridge. Extraction is inevitable in very deep crown-root fractures, the extreme being a vertical fracture

6-8 weeks C++

1 year C++



+= for crown fractured teeth with concomitant luxation injury, use the luxation followup schedule C++ = clinical and radiographic examination; Vol. 1 Issue 11 L.E.D. E-Journal

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Follow-Up Procedures

for fractures of teeth and alveolar bone


following:++ ROOT FRACTURE Clinical findings Radiographic findings Treatment Favorable Outcome Unfavorable Outcome ●The coronal segment may be

mobile and may be displaced. ● The tooth may be tender to percussion. ● Bleeding from the gingival sulcus may be noted. ● Sensibility testing may give negative results initially, indicating transient or permanent neural damage. ● Monitoring the status of the pulp is recommended. ● Transient crown discoloration (red or grey) may occur.

● The fracture involves the root of the tooth and is in a horizontal or oblique plane. ● Fractures that are in the horizontal plane can usually be detected in the regular periapical 90o angle film with the central beam through the tooth. This is usually the case with fractures in the cervical third of the root. ● If the plane of fracture is more oblique which is common with apical third fractures, an occlusal view or radiographs with varying horizontal angles are more likely to demonstrate the fracture including those located in the middle third.

● Reposition, if displaced, the coronal segment of the tooth as soon as possible. ● Check position radiographically. ● Stabilize the tooth with a flexible splint for 4 weeks. If the root fracture is near the cervical area of the tooth, stabilization is beneficial for a longer period of time (up to 4 months). ● It is advisable to monitor healing for at least one year to determine pulpal status. ● If pulp necrosis develops, root canal treatment of the coronal tooth segment to the fracture line is indicated to preserve the tooth.

4 Weeks S+, C++

6-8 Weeks C++

4 Months S++*, C++ 6 Months C++

1 Year C++ 5 Years C++

● Positive response to pulp testing (false negative possible up to 3 months). ● Signs of repair between fractured segments. ● Continue to next evaluation.

● Symptomatic ● Negative response to pulp testing (false negative possible up to 3 months). ● Extrusion of the coronal segment. ● Radiolucency at the fracture line. ● Clinical signs of periodontitis or abscess associated with the fracture line. ● Endodontic therapy appropriate for stage of root development is indicated.

ALVEOLAR FRACTURE Clinical findings Radiographic findings Treatment Follow-Up Favorable Outcome Unfavorable Outcome ● The fracture involves the

alveolar bone and may extend to adjacent bone. ● Segment mobility and dislocation with several teeth moving together are common findings. ● An occlusal change due to misalignment of the fractured alveolar segment is often noted. ● Sensibility testing may or may not be positive.

● Fracture lines may be located at any level, from the marginal bone to the root apex. ● In addition to the 3 angulations and occlusal film, additional views such as a panoramic radiograph can be helpful in determining the course and position of the fracture lines.

● Reposition any displaced segment and then splint. ● Suture gingival laceration if present. ● Stabilize the segment for 4 weeks.

4 Weeks S+, C++ 6-8 Weeks C++ 4 Months C++ 6 Months C++

1 Year C++

5 Years C++

● Positive response to pulp testing (false negative possible up to 3 months). ● No signs of apical periodontitis. ●Continue to next evaluation.

● Symptomatic ● Negative response to pulp testing (false negative possible up to 3 months). ● Signs of apical periodontitis or external inflammatory root resorption. ● Endodontic therapy appropriate for stage of root development is indicated.

S+=splint removal; S++=splint removal in cervical third fractures. C++ = clinical and radiographic examination. ++=Whenever there is evidence of external inflammatory root resorption, root canal therapy should be initiated immediately, with the use of calcium hydroxide as an intra-canal medication. Vol. 1 Issue 11 L.E.D. E-Journal

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2. Treatment Guidelines for Luxation Injuries

Follow-Up Procedures for luxated permanent teeth

Favorable and Unfavorable outcomes include some, but not necessarily all, of the following:++

CONCUSSION Clinical findings Radiographic findings Treatment Favorable Outcome Unfavorable Outcome ● The tooth is tender to touch

or tapping; it has not been displaced and does not have increased mobility. ● Sensibility tests are likely to give positive results.

●No radiographic abnormalities

● No treatment is needed. ● Monitor pulpal condition for at least one year.

4 Weeks C++

6-8 Weeks C++ 1 Year C++

● Asymptomatic ● Positive response to pulp testing ● False negative possible up to 3 months. ● Continuing root development in immature teeth ● Intact lamina dura

● Symptomatic ● Negative response to pulp testing ● False negative possible up to 3 months ●No continuing root development in immature teeth, signs of apical periodontitis. ● Endodontic therapy appropriate for stage of root development is indicated.

SUBLUXATION Clinical findings Radiographic findings Treatment Follow-Up Favorable Outcome Unfavorable Outcome ● The tooth is tender to touch

or tapping and has increased mobility; it has not been displaced. ● Bleeding from gingival crevice may be noted. ● Sensibility testing may be negative initially indicating transient pulpal damage. ● Monitor pulpal response until a definitive pulpal diagnosis can be made.

●Radiographic abnormalities are usually not found.

● Normally no treatment is needed, however a flexible splint to stabilize the tooth for patient comfort can be used for up to 2 weeks.

2 Weeks S+, C++

4 Weeks C++

6-8 Weeks C++

6 Months C++

1 Year C++

● Asymptomatic ● Positive response to pulp testing ● False negative possible up to 3 months. ● Continuing root development in immature teeth ● Intact lamina dura

● Symptomatic ● Negative response to pulp testing ● False negative possible up to 3 months ● External inflammatory resorption. ● No continuing root development in immature teeth, signs of apical periodontitis. ● Endodontic therapy appropriate for stage of root development is indicated.

EXTRUSIVE LUXATION Clinical Findings Radiographic findings Treatment Follow-Up Favorable Outcome Unfavorable Outcome ● The tooth appears elongated

and is excessively mobile. ● Sensibility tests will likely give negative results.

●Increased periodontal ligament space apically.

● Reposition the tooth by gently re-inserting It into the tooth socket. ● Stabilize the tooth for 2 weeks using a flexible splint. ● In mature teeth where pulp necrosis is anticipated or if several signs and symptoms indicate that the pulp of mature or immature teeth became necrotic, root canal treatment is indicated.

2 Weeks S+, C++ 4 Weeks C++

6-8 Weeks C++ 6 Months C++

1 Year C++

Yearly 5 years C++

● Asymptomatic ● Clinical and radiographic signs of normal or healed periodontium. ● Positive response to pulp testing (false negative possible up to 3 months). ● Marginal bone height corresponds to that seen radiographically after repositioning. ● Continuing root development in immature teeth.

● Symptoms and radiographic sign consistent with apical periodontitis. ● Negative response to pulp testing (false negative possible up to 3 months). ● If breakdown of marginal bone, splint for an additional 3-4 weeks. ● External inflammatory root resorption. ● Endodontic therapy appropriate for stage of root development is indicated.

S+=splint removal; C++ = clinical and radiographic examination. ++=Whenever there is evidence of external inflammatory root resorption, root canal therapy should be initiated immediately, with the use of calcium hydroxide as an intra-canal medication. Vol. 1 Issue 11 L.E.D. E-Journal

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Follow-Up Procedures for luxated permanent

teeth

Favorable and Unfavorable outcomes include some, but not necessarily all, of the following:++

LATERAL LUXATION Clinical findings Radiographic findings Treatment Favorable Outcome Unfavorable Outcome ● The tooth is displaced,

usually in a palatal/lingual or labial direction. ● It will be immobile and percussion usually gives a high, metallic (ankylotic) sound. ● Fracture of the alveolar process present. ● Sensibility tests will likely give negative results

● The widened periodontal ligament space is best seen on eccentric or occlusal exposures.

● Reposition the tooth digitally or with forceps to disengage it from its bony lock and gently reposition it into its original location. ● Stabilize the tooth for 4 weeks using a flexible splint. ● Monitor the pulpal condition. ● If the pulp becomes necrotic, root canal treatment is indicated to prevent root resorption.

2 Weeks, C++ 4 Weeks S+, C++ 6-8 Weeks C++

6 Months C++ 1 Year C++

Yearly for 5 years C++

● Asymptomatic ● Clinical and radiographic signs of normal or healed periodontium. ● Positive response to pulp testing (false negative possible up to 3 months). ● Marginal bone height corresponds to that seen radiographically after repositioning. ●Continuing root development in immature teeth

● Symptoms and radiographic signs consistent with apical periodontitis. ● Negative response to pulp testing (false negative possible up to 3 months). ● If breakdown of marginal bone, splint for an additional 3-4 weeks. ● External inflammatory root resorption or replacement resorption ● Endodontic therapy appropriate for stage of root development is indicated.

INTRUSIVE LUXATION Clinical findings Radiographic findings Treatment Follow-Up Favorable Outcome Unfavorable ● The tooth is displaced axially

into the alveolar bone. ● It is immobile and percussion may give a high, metallic (ankylotic) sound. ● Sensibility tests will likely give negative results.

●The periodontal ligament space may be absent from all or part of the root. ● The cemento-enamel junction is located more apically in the intruded tooth than in adjacent non-injured teeth, at times even apical to the marginal bone level.

Teeth with incomplete root formation ● Allow eruption without intervention ● If no movement within few weeks, initiate orthodontic repositioning. ● If tooth is intruded more than 7mm, reposition surgically or orthodontically. Teeth with complete root formation: ● Allow eruption without intervention if tooth intruded less than 3mm. If no movement after 2-4 weeks, reposition surgically or orthodontically before ankylosis can develop. ● If tooth is intruded 3-7 mm, reposition surgically or orthodontically. ● If tooth is intruded beyond 7mm, reposition surgically. ● The pulp will likely become necrotic in teeth with complete root formation. Root canal therapy using a temporary filling with calcium hydroxide is recommended and treatment should begin 2-3 weeks after repositioning. ● Once an intruded tooth has been repositioned surgically or orthodontically, stabilize with a flexible splint for 4 weeks.

2 Weeks, C++ 4 Weeks S+, C++

6-8 Weeks C++

6 Months C++

1 Year C++

Yearly for 5 years C++

● Tooth in place or erupting. ● Intact lamina dura ● No signs of resorption. ● Continuing root development in immature teeth.

● Tooth locked in place/ankylotic tone to percussion. ● Radiographic signs of apical periodontitis ● External inflammatory root resorption or replacement resorption. ● Endodontic therapy appropriate for stage of root development is indicated.

S+=splint removal; C++ = clinical and radiographic examination. ++= whenever there is evidence of external inflammatory root resorption, root canal therapy should be initiated immediately, with the use of calcium hydroxide as an intra-canal medication. Vol. 1 Issue 11 L.E.D. E-Journal

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Avulsion of permanent teeth

Avulsion of permanent teeth is seen in 0.5‐3% of all dental injuries (1,2). Numerous studies show that this injury is one of the most serious dental injuries and the prognosis is very much dependent on the actions taken at the place of accident and promptly after the avulsion (2‐27). Replantation is in most situations the treatment of choice, but cannot always be carried out immediately. An appropriate emergency management and treatment plan are important for a good prognosis. There are also individual situations when replantation is not indicated (e.g. severe caries or periodontal disease, non‐cooperating patient, severe medical conditions (e.g. immunosuppression and severe cardiac conditions) which must be dealt with individually. Replantation may successfully save the tooth, but it is important to realize that some of the replanted teeth have lower chances of long term survival and may even be lost or extracted at a later stage.

Guidelines for the emergency management are useful for delivering the best care possible in an efficient manner. The International Association of Dental Traumatology (IADT) has developed a consensus statement after an update of the dental literature and discussions in expert groups. Experienced international researchers and clinicians from various specialties and general dentistry were included in the groups. In cases in which the data did not appear conclusive, recommendations were based on the consensus opinion and in some situations on majority decision among the IADT board members. All recommendations are not evidence based on a high level. The guidelines should therefore be seen as the current best evidence and practice based on literature research and professionals’ opinion.

Guidelines should assist dentists, other health care professionals and patients in decision making. Also, they should be credible, readily understandable and practical with the aim of delivering appropriate care as effectively and efficiently as possible.It is understood that guidelines are to be applied with judgment of the specific clinical circumstances, clinicians’ judgments and patients’ characteristics, including but not limited to compliance, finances and understanding of the immediate and long‐term outcomes of treatment alternatives versus non‐treatment. The IADT cannot and does not guarantee favorable outcomes from strict adherence to the Guidelines, but believe that their application can maximize the chances of a favorable outcome. Guidelines undergo periodic updates. The following guidelines by the International Association of Dental Traumatology (IADT) represent an updated set of guidelines based on the original guidelines published in 2007 (28‐30).


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In these IADT Guidelines for management of avulsed permanent teeth the literature has been searched using Medline and Scopus databases using the search words: avulsion, exarticulation and replantation. The task group has then discussed the emergency treatment in detail and reached consensus of what to recommend today as best practice for the emergency management. This text is aiming at giving the concise, short necessary advice for treatment in the emergency situation. More detailed description of protocols, methods and documentation for clinical assessment and diagnosis of different dental injuries can be found in articles, textbooks and manuals (2,24) and in the interactive web site Dental Trauma Guide http://dentaltraumaguide.org

The final decision regarding patient care remains primarily in the hand of the treating dentist. For ethical reasons it is important that the dentist provides the patient and guardian with pertinent information relating to treatment so also the patient and guardian has as much influence in the decision making process as possible.

First aid for avulsed teeth at the place of accident (2,10,24,25,31‐55)

Dentists should always be prepared to give appropriate advice to the public about first aid for avulsed teeth. An avulsed permanent tooth is one of the few real emergency situations in dentistry. In addition to increasing the public awareness by, e.g. mass media campaigns, healthcare professionals. Guardians and teachers should receive information on how to proceed following these severe unexpected injuries. Also, instructions may be given by telephone to people at the emergency site. Immediate replantation is the best treatment at the place of accident. If for some reasons this cannot be carried out, there are alternatives such as using various storage media

If a tooth is avulsed, make sure it is a permanent tooth (primary teeth should not be replanted)

• Keep the patient calm. • Find the tooth and pick it up by the crown (the white part). Avoid touching the root. • If the tooth is dirty, wash it briefly (max 10 seconds) under cold running water and

reposition it. Try to encourage the patient/guardian to replant the tooth. Once the tooth is back in place, bite on a handkerchief to hold it in position.

• If this is not possible, or for other reasons when replantation of the avulsed tooth is not possible (e.g. an unconscious patient), place the tooth in a glass of milk or another suitable storage medium and bring with the patient to the emergency clinic. The tooth can also be transported in the mouth, keeping it inside the lip or cheek if the patient is conscious. If the patient is very young, he/she could swallow the tooth – therefor it is advisable to get the patient to spit in a container and place the tooth in it. Avoid storage in water!

• If there is access at the place of accident to special storage or transport media (e.g. tissue culture/transport medium, Hanks balanced storage medium (HBSS or saline) such media can preferably be used.

• Seek emergency dental treatment immediately.


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The poster ‘Save a Tooth’ is written for the public and is available in several languages: English, Spanish, Portuguese, French, Icelandic, Italian, Arabic and Turkish and can be obtained at the IADT website: http://www.iadt‐dentaltrauma.org.

Treatment guidelines for avulsed permanent teeth (56‐96)

Choice of treatment is related to the maturity of the root (open or closed apex) and the condition of the periodontal ligament cells. The condition of the cells is depending on the storage medium and the time out of the mouth, especially the dry time is critical for survival of the cells. After a dry time of 60 minutes or more all PDL cells are non‐viable. For this reason, the dry time of the tooth, before it was placed replanted or placed in a storage medium, is very important to assess from the patient’s history.

From a clinical point of view it is important for the clinician to roughly assess the condition of the cells by classifying the avulsed tooth into one of the following three groups before starting treatment:

o The PDL cells are most likely viable (i.e. the tooth has been replanted immediately or after a very short time at the place of accident)

o The PDL cells may be viable but compromised. The tooth has been kept in storage medium (e.g. tissue culture medium, HBSS, saline, milk or saliva and the total dry time has been less than 60 min).

o The PDL cells are non‐viable. Examples of this is when the trauma history tells us that the total extra‐oral dry time has been more than 60 min regardless of if the tooth was stored in an additional medium or not, or if the storage medium was non‐physiologic.

1. Treatment guidelines for avulsed permanent teeth with closed apex

1a. The tooth has been replanted before the patient’s arrival at the clinic

• Leave the tooth in place. • Clean the area with water spray, saline or chlorhexidine. • Suture gingival lacerations, if present. • Verify normal position of the replanted tooth both clinically and radiographically. • Apply a flexible splint for up to 2 weeks (see Splinting). • Administer systemic antibiotics. (see Antibiotics).


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• Check tetanus protection (see Tetanus). • Give patient instructions (See Patient instructions). • Initiate root canal treatment 7–10 days after replantation and before splint removal. ( See

Endodontic considerations). Follow‐up See: Follow‐up procedures

1b. The tooth has been kept in a physiologic storage medium or osmolality balanced medium and/or stored dry, the extraoral dry time has been less than 60 minutes

Physiologic storage media include e.g. tissue culture medium and cell transport media. Examples of osmolality balanced media are HBSS, saline and milk. Saliva can also be used.

• Clean the root surface and apical foramen with a stream of saline and soak the tooth in saline thereby removing contamination and dead cells from the root surface.

• Administer local anesthesia. • Irrigate the socket with saline. • Examine the alveolar socket. If there is a fracture of the socket wall, reposition it with a suitable

instrument. • Replant the tooth slowly with slight digital pressure. Do not use force. • Suture gingival lacerations, if present. • Verify normal position of the replanted tooth both clinically and radiographically. • Apply a flexible splint for up to 2 weeks, keep away from the gingiva. • Administer systemic antibiotics (see: Antibiotics). • Check tetanus protection (see Tetanus). • Give patient instructions (See Patient instructions). • Initiate root canal treatment 7–10 days after replantation and before splint removal (See

Endodontic considerations). Follow‐up See: Follow‐up procedures

1c. Dry time longer than 60 minutes or other reasons suggesting non‐viable cells

Delayed replantation has a poor long‐term prognosis. The periodontal ligament will be necrotic and not expected to heal. The goal in delayed replantation is, in addition to restoring the tooth for aesthetic, functional and psychological reasons, to maintain alveolar bone contour However, the expected eventual outcome is ankylosis and resorption of the root and the tooth will be lost eventually.

The technique for delayed replantation is:


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• Remove attached non‐viable soft tissue carefully e.g. with gauze. The best way to this has not yet been decided (See Future areas of research).

• Root canal treatment to the tooth can be carried out prior to replantation or later (See Endodontic considerations).

• In cases of delayed replantation, root canal treatment should be done either on the tooth prior to replantation, or it can be done 7–10 days later like in other replantation situations (See Endodontic considerations).

• Administer local anesthesia. • Irrigate the socket with saline. • Examine the alveolar socket. If there is a fracture of the socket wall, reposition it with a suitable

instrument. • Replant the tooth. • Suture gingival lacerations, if present. • Verify normal position of the replanted tooth clinically and radiographically. • Stabilize the tooth for 4 weeks using a flexible splint (See Splinting). • Administration of systemic antibiotics (See Antibiotics). • Check tetanus protection (See Tetanus). • Give patient instructions (See Patient instructions).

In order to slow down osseous replacement of the tooth, treatment of the root surface with fluoride

prior to replantation has been suggested (2% sodium fluoride solution for 20 min) but it should not be seen as an absolute recommendation Follow‐up See: Follow‐up procedures

In children and adolescents ankylosis is frequently associated with infraposition. Careful follow up is required and good communication is necessary to ensure the patient and guardian of this likely outcome. Decoronation may be necessary later when infraposition (>1mm) is seen. For more detailed information of this procedure the reader if referred to textbooks.

2. Treatment guidelines for avulsed permanent teeth with an open apex


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2a. The tooth has been replanted before the patient’s arrival at the clinic

• Leave the tooth in place. • Clean the area with water spray, saline or chlorhexidine. • Suture gingival lacerations, if present. • Verify normal position of the replanted tooth both clinically and radiographically. • Apply a flexible splint for up to 2 weeks (see Splinting). • Administer systemic antibiotics (see Antibiotics). • Check tetanus protection (see Tetanus). • Give patient instructions (see Patient instructions). • The goal for replanting still‐developing (immature) teeth in children is to allow for possible

revascularization of the pulp space. If that does not occur, root canal treatment may be recommended (see Endodontic considerations).

Follow‐up See: Follow‐up procedures

2b. The tooth has been kept in a physiologic storage medium or osmolality balanced medium and/or stored dry, the extraoral dry time has been less than 60 minutes

Physiologic storage media include e.g. tissue culture medium and cell transport media. Examples of osmolality balanced media are HBSS, saline and milk. Saliva can also be used.

• If contaminated, clean the root surface and apical foramen with a stream of saline. • Topical application of antibiotics has been shown to enhance chances for revascularization of

the pulp and can be considered if available (See Antibiotics). • Administer local anesthesia. • Examine the alveolar socket. • If there is a fracture of the socket wall, reposition it with a suitable instrument. • Remove the coagulum in the socket and replant the tooth slowly with slight digital pressure. • Suture gingival lacerations, especially in the cervical area. • Verify normal position of the replanted tooth clinically and radiographically. Apply a flexible

splint for up to 2 weeks (see splinting). • Administer systemic antibiotics (see Antibiotics). • Check tetanus protection (see Tetanus). • Give patient instructions (see Patient instructions). • The goal for replanting still‐developing (immature) teeth in children is to allow for possible

revascularization of the pulp space. The risk of infection related root resorption should be weighed up against the chances of revascularization. Such resorption is very rapid in teeth of children. If revascularization does not occur, root canal treatment may be recommended (see Endodontic considerations).


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Follow‐up See Follow‐up procedures.

2c. Dry time longer than 60 minutes or other reasons suggesting non‐viable cells

Delayed replantation has a poor long‐term prognosis. The periodontal ligament will be necrotic and not expected to heal. The goal in delayed replantation is to restore the tooth to the dentition for aesthetic, functional and psychological reasons and to maintain alveolar contour. The eventual outcome will be ankylosis and resorption of the root. The technique for delayed replantation is:

• Remove attached non‐viable soft tissue carefully e.g. with gauze. The best way to this has not yet been decided (See Future areas of research).

• Root canal treatment to the tooth can be carried out prior to replantation or later (See Endodontic considerations).

• Administer local anesthesia. • Remove the coagulum from the socket with a stream of saline. Examine the alveolar socket. If

there is a fracture of the socket wall, reposition it with a suitable instrument. • Replant the tooth slowly with slight digital pressure. Suture gingival laceration. Verify normal

position of the replanted tooth clinically and radiographically. • Stabilize the tooth for 4 weeks using a flexible splint (See Splinting). • Administer systemic antibiotics (See Antibiotics). • Check tetanus protection (See Tetanus). • Give patient instructions (See Patient instructions).

In order to slow down osseous replacement of the tooth, treatment of the root surface with fluoride prior to replantation (2% sodium fluoride solution for 20 min) has been suggested but it should not be seen as an absolute recommendation

Follow‐up See Follow‐up procedures.

Ankylosis is unavoidable after delayed replantation and must be taken into consideration. In children and adolescents ankylosis is frequently associated with infraposition. Careful follow up is required and good communication is necessary to ensure the patient and guardian of this likely outcome. Decoronation may be necessary when infraposition (>1mm) is seen. For more detailed information of this procedure the reader if referred to textbooks.

Anesthetics (64‐66)

Patients and guardians are recommended by us to do replantation at the place of accident without anesthesia. In the clinic however, where local anesthetics is available, there is no need not to


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omit local anesthesia, especially since there are often concomitant injuries. Concern is sometimes raised whether there are risks of compromising healing by using vasoconstrictor in the anesthesia. Evidence is weak for omitting vasoconstrictor in the oral & maxillofacial region and must be further documented before any recommendations against the use of it can be given (see suggested future areas of research at the end of this article). Block anesthesia (e.g. infraorbital nerve block) may be considered as an alternative to infiltration anesthesia in more severely injured areas and must be related to the clinicians’ experience of such blocking techniques.

Antibiotics (67‐76)

The value of systemic administration of antibiotics in human after replantation is still questionable as clinical studies have not demonstrated its value. Experimental studies have however, usually shown positive effects upon both periodontal and pulpal healing especially when administered topically. For this reason antibiotics are in most situations recommended after replantation of teeth. In addition, the patient’s medical status or concomitant injuries may warrant antibiotic coverage.

For systemic administration tetracycline is the first choice in appropriate dose for patient age and weight the first week after replantation. The risk of discoloration of permanent teeth must be considered before systemic administration of tetracycline in young patients. In many countries tetracycline is not recommended for patients under 12 years of age. A penicillin phenoxymethylpenicillin (Pen V,) or amoxycillin, in an appropriate dose for age and weight the first week, can be given as alternative to tetracycline.

Topical antibiotics (minocycline or doxycycline,1mg per 20ml of saline for 5 minutes soak) appear experimentally to have a beneficial effect in increasing the chance of pulpal space revascularization and periodontal healing and may be considered in immature teeth (2b).

Tetanus ( 2,24,25 ) Refer the patient to a physician for evaluation of need for a tetanus booster if the avulsed tooth

has contacted soil or tetanus coverage is uncertain.

Splinting of replanted teeth (77‐83)

It is considered best practice to maintain the repositioned tooth in correct position, provide patient comfort and improve function Current evidence supports short‐term, flexible splints for splinting of replanted teeth. Studies have shown that periodontal and pulpal healing is promoted if the replanted tooth is given a chance for slight motion and the splinting time is not too long. Given this there is so far no specific type of splint related to healing outcomes. The splint should be placed on the buccal surfaces of the maxillary teeth to enable lingual access for endodontic procedures and to avoid occlusal interference.


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Replanted permanent teeth should be splinted up to 2 weeks. Various types of acid etch bonded splints have been widely used to stabilize avulsed teeth because they allow good oral hygiene and are well tolerated by the patients. For a detailed description of how to make a splint the reader is referred to articles, textbooks and manuals and the web site Dental Trauma Guide www.dentaltraumaguide.org

Patient instructions (2,24,25)

Patient compliance with follow‐up visits and home care contributes to satisfactory healing following an injury. Both patients and guardians of young patients should be advised regarding care of the replanted tooth for optimal healing and prevention of further injury.

• Avoid participation in contact sports. • Soft diet for up to 2 weeks. Thereafter normal function as soon as possible • Brush teeth with a soft toothbrush after each meal • Use a chlorhexidine (0.1%) mouth rinse twice a day for 1 week.

Endodontic considerations (84‐94)

If root canal treatment is indicated (teeth with closed apex), the ideal time to begin treatment is 7–10 days post replantation. Calcium hydroxide is recommended as an intra‐canal medication for up to 1 month followed by root canal filling with an acceptable material. Alternatively if an antibiotic‐corticosteroid paste is chosen to be used as an anti‐inflammatory, anti‐clastic intra‐canal medicament, it may be placed immediately or shortly following replantation and left for at least 2 weeks. If the antibiotic in the paste is dechlortetracycline, there is a risk of tooth discoloration and care should be taken to confine the paste to the root canal and avoid contact of the paste with the pulp chamber walls

If the tooth has been dry for more than 60 min before replantation. The root canal treatment may be done extra‐orally prior to replantation

In teeth with open apexes, which have been replanted immediately or kept in appropriate storage media prior to replantation, pulp revascularization is possible. The risk of infection related root resorption should be weighed up against the chances of obtaining pulp space revascularization. Such resorption is very rapid in teeth of children. For very immature teeth root canal treatment should be avoided unless there is clinical or radiographic evidence of pulp necrosis.

Follow‐up procedures (2, 6‐9,24,25)

Clinical control


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Replanted teeth should be monitored by clinical and radiographic control after 4 weeks, 3 months, 6 months, one year and yearly thereafter. Clinical and radiographic examination will provide information to determine outcome. Evaluation may include the findings described as follows.

Favorable outcome

Closed apex. Asymptomatic, normal mobility, normal percussion sound. No radiographic evidence of resorption or periradicular osteitis: the lamina dura should appear normal.

Open apex. Asymptomatic, normal mobility, normal percussion sound. Radiographic evidence of arrested or continued root formation and eruption. Pulp canal obliteration is to be expected.

Unfavorable outcome

Closed apex. Symptomatic, excessive mobility or no mobility (ankylosis) with high‐pitched percussion sound. Radiographic evidence of resorption (inflammatory, infection‐related resorption, or ankylosis‐related replacement resorption). When ankylosis occurs in a growing patient, infraposition of the tooth is highly likely leading to disturbance in alveolar and facial growth over the short, medium and long term.

Open apex. Symptomatic, excessive mobility or no mobility (ankylosis) with high‐pitched percussion sound. In the case of ankylosis, the crown of the tooth will appear to be in an infraposition. Radiographic evidence of resorption (inflammatory, infection‐related resorption, or ankylosis‐related replacement resorption) or absence of continued root formation. When ankylosis occurs in a growing patient, infraposition of the tooth is highly likely to occur leading to disturbance of alveolar and facial growth over the short, medium and long term.

Loss of tooth In cases where teeth are lost in the emergency phase or will be lost later after trauma, discussions with colleagues, where available, who have expertise with managing such cases is prudent especially in growing patients. Ideally these discussions should take place before the tooth shows signs of infraposition. Appropriate treatment options may include decoronation, autotransplantation, resin retained bridge, denture, orthodontic space closure with composite modification and sectional osteotomy. Such treatment decisions are based on a full discussion with the child and parents, clinician’s expertise and aim to keep all options open until maturity is reached. After growth is completed implant treatment can also be considered. The clinician is referred to textbooks and articles for further readings regarding these procedures.

Future areas of research ‐ methods discussed but not included as recommendations in the guidelines this time


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A number of promising treatment procedures for avulsed teeth have been discussed in the consensus group. Some of these treatment suggestions do have certain experimental evidence and some of them are even used today in clinical practice: According to the group members, there is currently insufficient weight or quality of clinical and/or experimental evidence for some of these methods to be recognized as recommendations in the guidelines this time. These and some other important fields are examples where the group advocates further research and documentation:

⋅ Methods for removal of non‐viable PDL ⋅ Conditioning the PDL with extra oral storage in tissue culture media prior to replantation ⋅ Conditioning the PDL with enamel matrix protein prior to replantation for teeth with short

extra oral periods ⋅ Topical treatment of root surface with fluoride for teeth with long extra oral period ⋅ Revascularization of pulp space and methods promoting this ⋅ Optimal splint types with regards to periodontal and pulpal healing ⋅ Effect on adrenaline content of local anesthesia on healing ⋅ Reducing the inflammation with corticosteroids ⋅ Extra oral root filling of teeth with less than a 60 min drying period ⋅ Use of titanium posts for root elongation and as alternatives to conventional root canal

treatment ⋅ Long term development of alveolar crest following replantation and decoronation

Acknowledgment: The authors wish to express their gratefulness to the Dental Trauma Guide team in Copenhagen, Denmark www.dentaltraumaguide.org for permission to use their illustrations for these Guidelines.


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Primary dentition Guidelines

INJURIES IN THE PRIMARY DENTITION 1. Treatment guidelines for fractures of teeth and alveolar bone Follow-up Procedures

for fractures of teeth and alveolar bone


following: ENAMEL FRACTURE

Clinical findings Radiographic findings

Treatment

Favorable Outcome Unfavorable Outcome

● Fracture involves enamel. ● No radiographic abnormalities

● Smooth sharp edges.

ENAMEL DENTIN FRACTURE

Clinical findings


Treatment

Favorable Outcome Unfavorable Outcome

● Fracture involves enamel and dentin; the pulp is not exposed.

● No radiographic abnormalities The relation between the fracture and the pulp chamber will be disclosed

If possible, seal completely the involved dentin with glass ionomer to prevent microleakage. In case of large lost tooth structure, the tooth can be restored with composite.

3-4 weeks C

CROWN FRACTURE

WITH EXPOSED PULP Clinical findings


Treatment

Followup

Favorable Outcome

Unfavorable Outcome

● Fracture involves enamel and dentin and the pulp is exposed.

● The stage of root development can be determined from one exposure.

● If possible preserve pulp vitality by partial pulpotomy. Calcium hydroxide is a suitable material for such procedures. A well-condensed layer of pure calcium hydroxide paste can be applied over the pulp, covered with a lining such as reinforced glass ionomer. Restore the tooth with composite.

● The treatment is depending on the child´s maturity and ability to cope. Extraction is usually the alternative option.

1 week C 6-8 weeks C+R 1 year C+R

● Continuing root development in immature teeth and a hard tissue barrier.

● Signs of apical periodontitis; no continuing root development in immature teeth. Extraction or root canal treatment

C=Clinical examination; R=Radiographic examination Vol. 1 Issue 11 L.E.D. E-Journal

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Follow-Up Procedures for fractures of teeth

and alveolar bone


following: CROWN-ROOT FRACTURE Clinical findings Radiographic findings Treatment Favorable Outcome Unfavorable Outcome

● Fracture involves enamel, dentin and root structure; the pulp may or may not be exposed. ● Additional findings may include loose, but still attached, fragments of the tooth. ● There is minimal to moderate tooth displacement

● In laterally positioned fractures, the extent in relation to the gingival margin can be seen. One exposure is necessary to disclose multiple fragments

Depending on the clinical findings, two treatment scenarios may be considered:

● Fragment removal only. If the fracture involves only a small part of the root and the stable fragment is large enough to allow coronal restoration.

● Extraction in all other instances

In cases of fragment removal only: 1 week C 6-8 weeks C+R 1 year C(*)

● Asymptomatic; continuing root development in immature teeth

● Symptomatic; signs of apical periodontitis; no continuing root development in immature teeth. .

ROOT FRACTURE Clinical findings Radiographic findings Treatment Follow-Up Favorable Outcome Unfavorable Outcome

●The coronal fragment may be mobile and may be displaced.

● The fracture is usually located mid-root or in the apical third.

• If the coronal fragment is not displaced no treatment is required.

• If the coronal fragment is displaced, extract only that fragment. The apical fragment should be left to be resorbed

• No displacement: 1 week C, • 6-8 weeks C, • 1 year C+R and C(*) each subsequent year until exfoliation. • Extraction 1 year C+R and C(*)each subsequent year until exfoliation.

● Signs of repair between fractured segments. ● Continuous resorption of the left apical fragment

.

None

ALVEOLAR FRACTURE Clinical findings Radiographic findings Treatment Follow-Up Favorable Outcome Unfavorable Outcome

● The fracture involves the alveolar bone and may extend to adjacent bone. ● Segment mobility and dislocation are common findings. ● Occlusal interference is often noted. .

● The horizontal fracture line to the apices of the primary teeth and their permanent successors will be disclosed. ● A lateral radiograph may also give information about the relation between the two dentitions and if the segment is displaced in labial direction

● Reposition any displaced segment and then splint. ● General anesthesia is often indicated. ● Stabilize the segment for 4 weeks. ● Monitor teeth in fracture line

1 week C 3-4 weeks S+C+R 6-8 weeks C+R 1 year C+R and C(*) each subsequent year until exfoliation.

● Normal occlusion ● No signs of apical periodontitis. • No signs of disturbances in the permanent successors

● Signs of apical periodontitis or external inflammatory root resorption of primary teeth. ● Signs of disturbances in the permanent successors require follow-up until full eruption.

S=Splint removal C=Clinical examination; R=Radiographic examination; (C*)=Clinical and radiographic monitoring until eruption of the permanent successor Vol. 1 Issue 11 L.E.D. E-Journal

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2. Treatment guidelines for luxation injuries

Follow-Up Favorable and Unfavorable outcomes include some, but not necessarily all, of the

following: CONCUSSION Clinical findings Radiographic findings Treatment Favorable Outcome Unfavorable Outcome

● The tooth is tender to touch. It has normal mobility and no sulcular bleeding. .

No radiographic abnormalities. Normal periodontal space.

● No treatment is needed. Observation. .

1 week C 6-8 weeks C

● Continuing root development in immature teeth

● No continuing root development in immature teeth, periradicular radiolucencies. ● Crown dark discoloration. No treatment is needed unless a fistula develops.

SUBLUXATION Clinical findings Radiographic findings Treatment Follow-Up Favorable Outcome Unfavorable Outcome

● The tooth has increased mobility but has not been displaced. ● Bleeding from gingival crevice may be noted.

Radiographic abnormalities are usually not found. Normal periodontal space. An occlusal exposure is recommended in order to screen for possible signs of displacement or the presence of a root fracture. The radiograph can furthermore be used as a reference point in case of future complications.

● No treatment is needed. Observation. Brushing with a soft brush and use of chlorhexidine 0.12% alcohol-free topically to the affected area with cotton swabs twice a day for one week.

1 week C 6-8 weeks C Crown discoloration might occur. No treatment is needed unless a fistula develops. Dark discolored teeth should be followed carefully to detect sign of infection as soon as possible

● Continuing root development in immature teeth ● Transient red/gray discoloration. A yellow discoloration indicates pulp obliteration and has a good prognosis

● No continuing root development in immature teeth, periradicular radiolucencies. ● A dark persisting discoloration indicating pulp necrosis.

EXTRUSIVE LUXATION Clinical Findings Radiographic findings Treatment Follow-Up Favorable Outcome Unfavorable Outcome

● Partial displacement of the tooth out of its socket. ● The tooth appears elongated and can be excessively mobile. .

Increased periodontal ligament space apically.

• Treatment decisions are based on the degree of displacement, mobility, root formation and the ability of the child to cope with the emergency situation. ● For minor extrusion (< 3mm) in an immature developing tooth, careful repositioning or leaving the tooth for spontaneous alignment can be treatment options.

• Extraction is the treatment of choice for severe extrusion in a fully formed primary tooth.

1 week C 6-8 weeks C+R 6 months C+R 1 year C+R Discoloration might occur. Dark discolored teeth should be followed carefully to detect sign of infection as soon as possible.

● Continuing root development in immature teeth. ● Transient red/gray discoloration. A yellow discoloration indicates pulp obliteration and has a good prognosis.

● No continuing root development in immature teeth, periradicular radiolucencies. ● A dark persisting discoloration indicating pulp necrosis.

C=Clinical examination; R=Radiographic examination


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Follow-Up Favorable and Unfavorable outcomes include some, but not necessarily all, of the

following:

LATERAL LUXATION Clinical findings Radiographic findings Treatment Favorable Outcome Unfavorable Outcome ● The tooth is displaced,

usually in a palatal/lingual or labial direction. ● It will be immobile.

Increased periodontal ligament space apically is best seen on the occlusal exposure. And an occlusal exposure can sometimes also show the position of the displaced tooth and its relation to the permanent successor

● If there is no occlusal interference, as is often the case in anterior open bite, the tooth is allowed to reposition spontaneously.

● If minor occlusal interference, slight grinding is indicated.

● When there is more severe occlusal interference, the tooth can be gently repositioned by combined labial and palatal pressure after the use of local anesthesia.

● In severe displacement, when the crown is dislocated in a labial direction, extraction is the treatment of choice.

.

1 week C 2-3 weeks C 6-8 weeks C+R 1 year C+R

● Asymptomatic ● Clinical and radiographic signs of normal or healed periodontium. ● Transient discoloration might occur

● Symptoms and radiographic sign consistent with periodontitis. ● Grey persistent discoloration

INTRUSIVE LUXATION Clinical findings Radiographic findings Treatment Follow-Up Favorable Outcome Unfavorable Outcome ● The tooth is usually

displaced through the labial bone plate, or can be impinging upon the succedaneous tooth bud

When the apex is displaced toward or through the labial bone plate, the apical tip can be visualized and appears shorter than its contra lateral.

When the apex is displaced towards the permanent tooth germ, the apical tip cannot be visualized and the tooth appears elongated

If the apex is displaced toward or through the labial bone plate, the tooth is left for spontaneous repositioning

If the apex is displaced into the developing tooth germ, extract

1 week C 3-4 weeks C + R 6-8 weeks C 6 months C+R ● 1 year C+R and (C*)

● Tooth in place or erupting. ● No or transient discoloration.

● Tooth locked in place ● Radiographic signs of apical periodontitis ● Persistent discoloration ● Damage to the permanent successor.

C=Clinical examination; R=Radiographic examination; (C*)=Clinical and radiographic monitoring until eruption of the permanent successor


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AVULSION Clinical findings Radiographic findings Treatment Follow-Up Favorable Outcome Unfavorable Outcome

The tooth is completely out of the socket

A radiographic examination is essential to ensure that the missing tooth is not intruded.

It is not recommended to replant avulsed primary teeth.

1 week C 6 months C + R • 1 year C + R and (C*)

Damage to the permanent successor.

C=Clinical examination; R=Radiographic examination; (C*)=Clinical and radiographic monitoring until eruption of the permanent successor


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2012 GUIDELINES COMMITTEES

FRACTURES AND LUXATIONS OF PERMANENT TEETH: Dr. Jens Andreasen, Denmark Dr. Anthony DiAngelis, USA Dr. Kurt Ebeleseder, Austria Dr. David Kenny, Canada Dr. Asgeir Sigurdsson, Iceland Dr. Martin Trope, USA AVULSION OF PERMANENT TEETH: Dr. Lars Andersson, Kuwait Dr. Jens O Andreasen, Denmark Dr. Peter Day, United Kingdom Dr. Geoffrey Heithersay, Australia Dr. Yango Pohl, Germany Dr. Martin Trope, USA TRAUMATIC INJURIES TO PRIMARY TEETH: Dr. Jens Andreasen, Denmark Dr. Marie Therese Flores, Chile Dr. Barbro Malmgren, Sweden Dr. Agneta Robertson, Sweden IADT, BOARD OF DIRECTORS, 2012 Dr. Lars Andersson, President, Kuwait Dr. Anthony J. DiAngelis, President Elect, USA Dr. Lamar Hicks, Secretary/Treasurer, USA Dr. Mitsuhiro Tsukiboshi, Immediate‐Past President, Japan Dr. Giacomo Cavalleri, Italy Dr. Nestor Cohenca, USA Dr. Peter Day, UK Dr. Olle Malmgren, Sweden Dr. Alex J. Moule, Australia Dr. Juan E. Onetto, Chile Dr. Yango Pohl, Germany

References for all Guidelines can be viewed on the originally published works: Link to > > Section 1. Fractures and luxations of permanent teeth

Link to > > Section 2. Avulsion of permanent teeth

Link to > > Section 3. Traumatic injuries to primary teeth


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http://onlinelibrary.wiley.com/doi/10.1111/j.1600-9657.2012.01125.x/references



L.E.D. E-Journal

Bio-Medical Waste

The IDA Ludhiana Branch official publication, ‘L.E.D.’ – ‘Let’s

Enjoy Dentistry’ strives to keep dentists connected with the

latest rules and regulations. The brand new additions in this

series are the Bio-Medical Waste (Management and Handling)

Rules, 2016.

Bio-Medical Waste is waste that is either putrescible or

potentially infectious. Bio-Medical waste also includes the

waste associated with the generation of biomedical waste that

visually appears to be of medical or laboratory origin (e.g.,

packaging, unused bandages, infusion kits, etc.), as well

research laboratory waste containing biomolecules or

organisms that are restricted from environmental release.

Discarded sharps are considered biomedical waste whether

they are contaminated or not, due to the possibility of being

contaminated with blood and their propensity to cause injury

when not properly contained and disposed of Disposal of this

waste is an environmental concern, as many medical wastes

are classified as infectious or biohazardous & could potentially

lead to the spread of infectious disease.

The Bio-medical Waste (Management and Handling)

Rules, 1998 & further amendments were passed for the

regulation of bio-medical waste management in 1998 & on 28th

Mar 2016 Biomedical Waste Management Rules 2016 were

notified by Central Govt. Each State's Pollution Control Board

or Pollution control Committee will be responsible for

implementing the new legislation.

Biomedical waste must be properly managed and

disposed of to protect the environment, general public and

workers, especially healthcare and sanitation workers who are

at risk of exposure to biomedical waste as an occupational

hazard. Steps in the management of biomedical waste include

generation, accumulation, handling, storage, treatment,

transport and disposal.


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https://en.wikipedia.org/wiki/Sharps_waste

https://en.wikipedia.org/wiki/Environmentalism

https://en.wikipedia.org/wiki/Infectious_disease

1

[Published in the Gazette of India, Extraordinary, Part II, Section 3, Sub-section (i)]

GOVERNMENT OF INDIA

MINISTRY OF ENVIRONMENT, FOREST AND CLIMATE CHANGE

NOTIFICATION

New Delhi, the 28th

March, 2016

G.S.R. 343(E).-Whereas the Bio-Medical Waste (Management and Handling) Rules, 1998 was published

vide notification number S.O. 630 (E) dated the 20th July, 1998, by the Government of India in the

erstwhile Ministry of Environment and Forests, provided a regulatory frame work for management of

bio-medical waste generated in the country;

And whereas, to implement these rules more effectively and to improve the collection,

segregation, processing, treatment and disposal of these bio-medical wastes in an environmentally sound

management thereby, reducing the bio- medical waste generation and its impact on the environment, the

Central Government reviewed the existing rules;

And whereas, in exercise of the powers conferred by sections 6, 8 and 25 of the Environment

(Protection) Act, 1986 (29 of 1986), the Central Government published the draft rules in the Gazette vide

number G.S.R. 450 (E), dated the 3rd

June, 2015 inviting objections or suggestions from the public within

sixty days from the date on which copies of the Gazette containing the said notification were made

available to the public;

And whereas, the copies of the Gazette containing the said draft rules were made available to the

public on the 3rd

June, 2015;

And whereas, the objections or comments received within the specified period from the public in

respect of the said draft rules have been duly considered by the Central Government;

Now, therefore, in exercise of the powers conferred by section 6, 8 and 25 of the Environment

(Protection) Act, 1986 (29 of 1986), and in supersession of the Bio-Medical Waste (Management and

Handling) Rules, 1998, except as respects things done or omitted to be done before such suppression, the

Central Government hereby makes the following rules, namely:-

1. Short title and commencement.- (1) these rules may be called the Bio-Medical Waste Management

Rules, 2016.

(2) They shall come into force on the date of their publication in the Official Gazette.

2. Application.-

(1) These rules shall apply to all persons who generate, collect, receive, store, transport, treat,

dispose, or handle bio medical waste in any form including hospitals, nursing homes, clinics,

dispensaries, veterinary institutions, animal houses, pathological laboratories, blood banks, ayush


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2

hospitals, clinical establishments, research or educational institutions, health camps, medical or surgical

camps, vaccination camps, blood donation camps, first aid rooms of schools, forensic laboratories and

research labs.

(2). These rules shall not apply to,-

(a) radioactive wastes as covered under the provisions of the Atomic Energy Act, 1962(33 of

1962) and the rules made there under;

(b) hazardous chemicals covered under the Manufacture, Storage and Import of Hazardous

Chemicals Rules, 1989 made under the Act;

(c) solid wastes covered under the Municipal Solid Waste (Management and Handling) Rules,

2000 made under the Act;

(d) the lead acid batteries covered under the Batteries (Management and Handling) Rules, 2001

made under the Act;

(e) hazardous wastes covered under the Hazardous Wastes (Management, Handling and

Transboundary Movement) Rules, 2008 made under the Act;

(f) waste covered under the e-Waste (Management and Handling) Rules, 2011 made under the

Act; and

(g) hazardous micro organisms, genetically engineered micro organisms and cells covered under

the Manufacture, Use, Import, Export and Storage of Hazardous Microorganisms,

Genetically Engineered Micro organisms or Cells Rules, 1989 made under the Act.

3. Definitions.- In these rules, unless the context otherwise requires, -

(a) "Act" means the Environment (Protection) Act, 1986 (29 of 1986);

(b) "animal house" means a place where animals are reared or kept for the purpose of experiments or

testing;

(c) "authorisation" means permission granted by the prescribed authority for the generation, collection,

reception, storage, transportation, treatment, processing, disposal or any other form of handling of

bio-medical waste in accordance with these rules and guidelines issued by the Central Government

or Central Pollution Control Board as the case may be;

(d) "authorised person" means an occupier or operator authorised by the prescribed authority to

generate, collect, receive, store, transport, treat, process, dispose or handle bio-medical waste in

accordance with these rules and the guidelines issued by the Central Government or the Central

Pollution Control Board, as the case may be;


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(e) "biological" means any preparation made from organisms or micro-organisms or product of

metabolism and biochemical reactions intended for use in the diagnosis, immunisation or the

treatment of human beings or animals or in research activities pertaining thereto;

(f) "bio-medical waste" means any waste, which is generated during the diagnosis, treatment or

immunisation of human beings or animals or research activities pertaining thereto or in the

production or testing of biological or in health camps, including the categories mentioned in

Schedule I appended to these rules;

(g) "bio-medical waste treatment and disposal facility" means any facility wherein treatment, disposal

of bio-medical waste or processes incidental to such treatment and disposal is carried out, and

includes common bio-medical waste treatment facilities;

(h) “Form” means the Form appended to these rules;

(i) “handling” in relation to bio-medical waste includes the generation, sorting, segregation,

collection, use, storage, packaging, loading, transportation, unloading, processing, treatment,

destruction, conversion, or offering for sale, transfer, disposal of such waste;

(j) “health care facility” means a place where diagnosis, treatment or immunisation of human beings

or animals is provided irrespective of type and size of health treatment system, and research

activity pertaining thereto;

(k) “major accident” means accident occurring while handling of bio-medical waste having potential to

affect large masses of public and includes toppling of the truck carrying bio-medical waste,

accidental release of bio-medical waste in any water body but exclude accidents like needle prick

injuries, mercury spills;

(l) “management” includes all steps required to ensure that bio- medical waste is managed in such a

manner as to protect health and environment against any adverse effects due to handling of such

waste;

(m) "occupier" means a person having administrative control over the institution and the premises

generating bio-medical waste, which includes a hospital, nursing home, clinic, dispensary,

veterinary institution, animal house, pathological laboratory, blood bank, health care facility and

clinical establishment, irrespective of their system of medicine and by whatever name they are

called;

(n) "operator of a common bio-medical waste treatment facility" means a person who owns or controls

a Common Bio-medical Waste Treatment Facility (CBMWTF) for the collection, reception,

storage, transport, treatment, disposal or any other form of handling of bio-medical waste;

(o) “prescribed authority” means the State Pollution Control Board in respect of a State and Pollution

Control Committees in respect of an Union territory;

(p) "Schedule" means the Schedule appended to these rules.


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4. Duties of the Occupier.- It shall be the duty of every occupier to-

(a) take all necessary steps to ensure that bio-medical waste is handled without any adverse effect to

human health and the environment and in accordance with these rules;

(b) make a provision within the premises for a safe, ventilated and secured location for storage of

segregated biomedical waste in colored bags or containers in the manner as specified in Schedule I,

to ensure that there shall be no secondary handling, pilferage of recyclables or inadvertent

scattering or spillage by animals and the bio-medical waste from such place or premises shall be

directly transported in the manner as prescribed in these rules to the common bio-medical waste

treatment facility or for the appropriate treatment and disposal, as the case may be, in the manner

as prescribed in Schedule I;

(c) pre-treat the laboratory waste, microbiological waste, blood samples and blood bags through

disinfection or sterilisation on-site in the manner as prescribed by the World Health Organisation

(WHO) or National AIDs Control Organisation (NACO) guidelines and then sent to the common

bio-medical waste treatment facility for final disposal;

(d) phase out use of chlorinated plastic bags, gloves and blood bags within two years from the date of

notification of these rules;

(e) dispose of solid waste other than bio-medical waste in accordance with the provisions of

respective waste management rules made under the relevant laws and amended from time to time;

(f) not to give treated bio-medical waste with municipal solid waste;

(g) provide training to all its health care workers and others, involved in handling of bio medical waste

at the time of induction and thereafter at least once every year and the details of training

programmes conducted, number of personnel trained and number of personnel not undergone any

training shall be provided in the Annual Report;

(h) immunise all its health care workers and others, involved in handling of bio-medical waste for

protection against diseases including Hepatitis B and Tetanus that are likely to be transmitted by

handling of bio-medical waste, in the manner as prescribed in the National Immunisation Policy or

the guidelines of the Ministry of Health and Family Welfare issued from time to time;

(i) establish a Bar- Code System for bags or containers containing bio-medical waste to be sent out of

the premises or place for any purpose within one year from the date of the notification of these

rules;

(j) ensure segregation of liquid chemical waste at source and ensure pre-treatment or neutralisation

prior to mixing with other effluent generated from health care facilities;

(k) ensure treatment and disposal of liquid waste in accordance with the Water (Prevention and

Control of Pollution) Act, 1974 ( 6 of 1974);


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(l) ensure occupational safety of all its health care workers and others involved in handling of bio-

medical waste by providing appropriate and adequate personal protective equipments;

(m) conduct health check up at the time of induction and at least once in a year for all its health care

workers and others involved in handling of bio- medical waste and maintain the records for the

same;

(n) maintain and update on day to day basis the bio-medical waste management register and display

the monthly record on its website according to the bio-medical waste generated in terms of

category and colour coding as specified in Schedule I;

(o) report major accidents including accidents caused by fire hazards, blasts during handling of bio-

medical waste and the remedial action taken and the records relevant thereto, (including nil report)

in Form I to the prescribed authority and also along with the annual report;

(p) make available the annual report on its web-site and all the health care facilities shall make own

website within two years from the date of notification of these rules;

(q) inform the prescribed authority immediately in case the operator of a facility does not collect the

bio-medical waste within the intended time or as per the agreed time;

(r) establish a system to review and monitor the activities related to bio-medical waste management,

either through an existing committee or by forming a new committee and the Committee shall

meet once in every six months and the record of the minutes of the meetings of this committee

shall be submitted along with the annual report to the prescribed authority and the healthcare

establishments having less than thirty beds shall designate a qualified person to review and monitor

the activities relating to bio-medical waste management within that establishment and submit the

annual report;

(s) maintain all record for operation of incineration, hydro or autoclaving etc., for a period of five

years;

(t) existing incinerators to achieve the standards for treatment and disposal of bio-medical waste as

specified in Schedule II for retention time in secondary chamber and Dioxin and Furans within two

years from the date of this notification.

5. Duties of the operator of a common bio-medical waste treatment and disposal facility.-It shall be

the duty of every operator to -

(a) take all necessary steps to ensure that the bio-medical waste collected from the occupier is

transported, handled, stored, treated and disposed of, without any adverse effect to the human

health and the environment, in accordance with these rules and guidelines issued by the Central

Government or, as the case may be, the central pollution control board from time to time;

(b) ensure timely collection of bio-medical waste from the occupier as prescribed under these rules;

(c) establish bar coding and global positioning system for handling of bio- medical waste within one

year;


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(d) inform the prescribed authority immediately regarding the occupiers which are not handing over

the segregated bio-medical waste in accordance with these rules;

(e) provide training for all its workers involved in handling of bio-medical waste at the time of

induction and at least once a year thereafter;

(f) assist the occupier in training conducted by them for bio-medical waste management;

(g) undertake appropriate medical examination at the time of induction and at least once in a year and

immunise all its workers involved in handling of bio-medical waste for protection against diseases,

including Hepatitis B and Tetanus, that are likely to be transmitted while handling bio-medical

waste and maintain the records for the same;

(h) ensure occupational safety of all its workers involved in handling of bio-medical waste by

providing appropriate and adequate personal protective equipment;

(i) report major accidents including accidents caused by fire hazards, blasts during handling of bio-

medical waste and the remedial action taken and the records relevant thereto, (including nil report)

in Form I to the prescribed authority and also along with the annual report;

(i) maintain a log book for each of its treatment equipment according to weight of batch; categories of

waste treated; time, date and duration of treatment cycle and total hours of operation;

(k) allow occupier , who are giving waste for treatment to the operator, to see whether the treatment is

carried out as per the rules;

(l) shall display details of authorisation, treatment, annual report etc on its web-site;

(m) after ensuring treatment by autoclaving or microwaving followed by mutilation or shredding,

whichever is applicable, the recyclables from the treated bio-medical wastes such as plastics and

glass, shall be given to recyclers having valid consent or authorisation or registration from the

respective State Pollution Control Board or Pollution Control Committee;

(n) supply non-chlorinated plastic coloured bags to the occupier on chargeable basis, if required;

(o) common bio-medical waste treatment facility shall ensure collection of biomedical waste on

holidays also;

(p) maintain all record for operation of incineration, hydroor autoclaving for a period of five years;

and

(q) upgrade existing incinerators to achieve the standards for retention time in secondary chamber and

Dioxin and Furans within two years from the date of this notification.

6. Duties of authorities.-The Authority specified in column (2) of Schedule-III shall perform the

duties as specified in column (3) thereof in accordance with the provisions of these rules.


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7. Treatment and disposal.- (1) Bio-medical waste shall be treated and disposed of in accordance

with Schedule I, and in compliance with the standards provided in Schedule-II by the health care

facilities and common bio-medical waste treatment facility.

(2) Occupier shall hand over segregated waste as per the Schedule-I to common bio-medical waste

treatment facility for treatment, processing and final disposal:

Provided that the lab and highly infectious bio-medical waste generated shall be pre-treated by

equipment like autoclave or microwave.

(3) No occupier shall establish on-site treatment and disposal facility, if a service of ` common bio-

medical waste treatment facility is available at a distance of seventy-five kilometer.

(4) In cases where service of the common bio-medical waste treatment facility is not available, the

Occupiers shall set up requisite biomedical waste treatment equipment like incinerator, autoclave

or microwave, shredder prior to commencement of its operation, as per the authorisation given by

the prescribed authority.

(5) Any person including an occupier or operator of a common bio medical waste treatment facility,

intending to use new technologies for treatment of bio medical waste other than those listed in

Schedule I shall request the Central Government for laying down the standards or operating

parameters.

(6) On receipt of a request referred to in sub-rule (5), the Central Government may determine the

standards and operating parameters for new technology which may be published in Gazette by

the Central Government.

(7) Every operator of common bio-medical waste treatment facility shall set up requisite biomedical

waste treatment equipments like incinerator, autoclave or microwave, shredder and effluent

treatment plant as a part of treatment, prior to commencement of its operation.

(8) Every occupier shall phase out use of non-chlorinated plastic bags within two years from the date

of publication of these rules and after two years from such publication of these rules, the

chlorinated plastic bags shall not be used for storing and transporting of bio-medical waste and

the occupier or operator of a common bio-medical waste treatment facility shall not dispose of

such plastics by incineration and the bags used for storing and transporting biomedical waste

shall be in compliance with the Bureau of Indian Standards. Till the Standards are published, the

carry bags shall be as per the Plastic Waste Management Rules, 2011.

(9) After ensuring treatment by autoclaving or microwaving followed by mutilation or shredding,

whichever is applicable, the recyclables from the treated bio-medical wastes such as plastics and

glass shall be given to such recyclers having valid authorisation or registration from the

respective prescribed authority.

(10) The Occupier or Operator of a common bio-medical waste treatment facility shall maintain a

record of recyclable wastes referred to in sub-rule (9) which are auctioned or sold and the same

shall be submitted to the prescribed authority as part of its annual report. The record shall be

open for inspection by the prescribed authorities.


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(11) The handling and disposal of all the mercury waste and lead waste shall be in accordance with

the respective rules and regulations.

8. Segregation, packaging, transportation and storage.-(1) No untreated bio-medical waste

shall be mixed with other wastes.

(2) The bio-medical waste shall be segregated into containers or bags at the point of generation in

accordance with Schedule I prior to its storage, transportation, treatment and disposal.

(3) The containers or bags referred to in sub-rule (2) shall be labeled as specified in Schedule IV.

(4) Bar code and global positioning system shall be added by the Occupier and common bio-medical

waste treatment facility in one year time.

(5) The operator of common bio-medical waste treatment facility shall transport the bio-medical waste

from the premises of an occupier to any off-site bio-medical waste treatment facility only in the

vehicles having label as provided in part ‘A’ of the Schedule IV along with necessary information

as specified in part ‘B’ of the Schedule IV.

(6) The vehicles used for transportation of bio-medical waste shall comply with the conditions if any

stipulated by the State Pollution Control Board or Pollution Control Committee in addition to the

requirement contained in the Motor Vehicles Act, 1988 (59 of 1988), if any or the rules made there

under for transportation of such infectious waste.

(7) Untreated human anatomical waste, animal anatomical waste, soiled waste and, biotechnology

waste shall not be stored beyond a period of forty –eight hours:

Provided that in case for any reason it becomes necessary to store such waste beyond

such a period, the occupier shall take appropriate measures to ensure that the waste does not

adversely affect human health and the environment and inform the prescribed authority along with

the reasons for doing so.

(8) Microbiology waste and all other clinical laboratory waste shall be pre-treated by sterilisation to

Log 6 or disinfection to Log 4, as per the World Health Organisation guidelines before packing

and sending to the common bio-medical waste treatment facility.

9. Prescribed authority.-(1) The prescribed authority for implementation of the provisions of these

rules shall be the State Pollution Control Boards in respect of States and Pollution Control Committees in

respect of Union territories.

(2) The prescribed authority for enforcement of the provisions of these rules in respect of all health

care establishments including hospitals, nursing homes, clinics, dispensaries, veterinary

institutions, animal houses, pathological laboratories and blood banks of the Armed Forces under

the Ministry of Defence shall be the Director General, Armed Forces Medical Services, who shall

function under the supervision and control of the Ministry of Defence.


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(3) The prescribed authorities shall comply with the responsibilities as stipulated in Schedule III of

these rules.

10. Procedure for authorisation.-Every occupier or operator handling bio-medical waste, irrespective

of the quantity shall make an application in Form II to the prescribed authority i.e. State Pollution

Control Board and Pollution Control Committee, as the case may be, for grant of authorisation and

the prescribed authority shall grant the provisional authorisation in Form III and the validity of

such authorisation for bedded health care facility and operator of a common facility shall be

synchronised with the validity of the consents.

(1) The authorisation shall be one time for non-bedded occupiers and the authorisation in such cases

shall be deemed to have been granted, if not objected by the prescribed authority within a period of

ninety days from the date of receipt of duly completed application along with such necessary

documents.

(2) In case of refusal of renewal, cancellation or suspension of the authorisation by the prescribed

authority, the reasons shall be recorded in writing:

Provided that the prescribed authority shall give an opportunity of being heard to the

applicant before such refusal of the authorisation.

(3) Every application for authorisation shall be disposed of by the prescribed authority within a period

of ninety days from the date of receipt of duly completed application along with such necessary

documents, failing which it shall be deemed that the authorisation is granted under these rules.

(4) In case of any change in the bio-medical waste generation, handling, treatment and disposal for

which authorisation was earlier granted, the occupier or operator shall intimate to the prescribed

authority about the change or variation in the activity and shall submit a fresh application in Form

II for modification of the conditions of authorisation.

11. Advisory Committee.-(1) Every State Government or Union territory Administration shall

constitute an Advisory Committee for the respective State or Union territory under the chairmanship of

the respective health secretary to oversee the implementation of the rules in the respective state and to

advice any improvements and the Advisory Committee shall include representatives from the

Departments of Health, Environment, Urban Development, Animal Husbandry and Veterinary Sciences

of that State Government or Union territory Administration, State Pollution Control Board or Pollution

Control Committee, urban local bodies or local bodies or Municipal Corporation, representatives from

Indian Medical Association, common bio-medical waste treatment facility and non-governmental

organisation.

(2) Notwithstanding anything contained in sub-rule (1), the Ministry of Defence shall constitute the

Advisory Committee (Defence) under the chairmanship of Director General of Health Services of

Armed Forces consisting of representatives from the Ministry of Defence, Ministry of

Environment, Forest and Climate Change, Central Pollution Control Board, Ministry of Health and

Family Welfare, Armed Forces Medical College or Command Hospital.


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(3) The Advisory Committee constituted under sub-rule (1) and (2) shall meet at least once in six

months and review all matters related to implementation of the provisions of these rules in the

State and Armed Forces Health Care Facilities, as the case may be.

(4) The Ministry of Health and Defence may co-opt representatives from the other Governmental and

non-governmental organisations having expertise in the field of bio-medical waste management.

12. Monitoring of implementation of the rules in health care facilities.- (1) The Ministry of

Environment, Forest and Climate Change shall review the implementation of the rules in the country

once in a year through the State Health Secretaries and Chairmen or Member Secretary of State Pollution

Control Boards and Central Pollution Control Board and the Ministry may also invite experts in the field

of bio-medical waste management, if required.

(2) The Central Pollution Control Board shall monitor the implementation of these rules in respect of

all the Armed Forces health care establishments under the Ministry of Defence.

(3) The Central Pollution Control Board along with one or more representatives of the Advisory

Committee constituted under sub-rule (2) of rule 11, may inspect any Armed Forces health care

establishments after prior intimation to the Director General Armed Forces Medical

Services.

(4) Every State Government or Union territory Administration shall constitute District Level

Monitoring Committee in the districts under the chairmanship of District Collector or District

Magistrate or Deputy Commissioner or Additional District Magistrate to monitor the compliance

of the provisions of these rules in the health care facilities generating bio-medical waste and in the

common bio-medical waste treatment and disposal facilities, where the bio-medical waste is

treated and disposed of.

(5) The District Level Monitoring Committee constituted under sub-rule (4) shall submit its report

once in six months to the State Advisory Committee and a copy thereof shall also be forwarded to

State Pollution Control Board or Pollution Control Committee concerned for taking further

necessary action.

(6) The District Level Monitoring Committee shall comprise of District Medical Officer or District

Health Officer, representatives from State Pollution Control Board or Pollution Control

Committee, Public Health Engineering Department, local bodies or municipal corporation, Indian

Medical Association, common bio-medical waste treatment facility and registered non-

governmental organisations working in the field of bio-medical waste management and the

Committee may co-opt other members and experts, if necessary and the District Medical Officer

shall be the Member Secretary of this Committee.

13. Annual report.-(1) Every occupier or operator of common bio-medical waste treatment facility

shall submit an annual report to the prescribed authority in Form-IV, on or before the 30th June of every

year.

(2) The prescribed authority shall compile, review and analyse the information received and send this

information to the Central Pollution Control Board on or before the 31st July of every year.


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(3) The Central Pollution Control Board shall compile, review and analyse the information received

and send this information, along with its comments or suggestions or observations to the Ministry

of Environment, Forest and Climate Change on or before 31st

August every year.

(4) The Annual Reports shall also be available online on the websites of Occupiers, State Pollution

Control Boards and Central Pollution Control Board.

14. Maintenance of records.- (1) Every authorised person shall maintain records related to the

generation, collection, reception, storage, transportation, treatment, disposal or any other form of

handling of bio-medical waste, for a period of five years, in accordance with these rules and

guidelines issued by the Central Government or the Central Pollution Control Board or the

prescribed authority as the case may be.

(2) All records shall be subject to inspection and verification by the prescribed authority or the

Ministry of Environment, Forest and Climate Change at any time.

15. Accident reporting.- (1) In case of any major accident at any institution or facility or any other

site while handling bio-medical waste, the authorised person shall intimate immediately to the prescribed

authority about such accident and forward a report within twenty-four hours in writing regarding the

remedial steps taken in Form I.

(2) Information regarding all other accidents and remedial steps taken shall be provided in the annual

report in accordance with rule 13 by the occupier.

16. Appeal.-(1) Any person aggrieved by an order made by the prescribed authority under these

rules may, within a period of thirty days from the date on which the order is communicated to him, prefer

an appeal in Form V to the Secretary (Environment) of the State Government or Union territory

administration .

(2) Any person aggrieved by an order of the Director General Armed Forces Medical Services under

these rules may, within thirty days from the date on which the order is communicated to him,

prefer an appeal in Form V to the Secretary, Ministry of Environment, Forest and Climate Change.

(3) The authority referred to in sub-para (1) and (2) as the case may be, may entertain the appeal after

the expiry of the said period of thirty days, if it is satisfied that the appellant was prevented by

sufficient cause from filing the appeal in time.

(4) The appeal shall be disposed of within a period of ninety days from the date of its filing.

17. Site for common bio-medical waste treatment and disposal facility.-(1) Without

prejudice to rule 5 of these rules, the department in the business allocation of land assignment shall be

responsible for providing suitable site for setting up of common biomedical waste treatment and disposal

facility in the State Government or Union territory Administration.


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(2) The selection of site for setting up of such facility shall be made in consultation with the prescribed

authority, other stakeholders and in accordance with guidelines published by the Ministry of

Environment, Forest and Climate Change or Central Pollution Control Board.

18. Liability of the occupier, operator of a facility.- (1) The occupier or an operator of a common

bio-medical waste treatment facility shall be liable for all the damages caused to the environment or the

public due to improper handling of bio- medical wastes.

(2) The occupier or operator of common bio-medical waste treatment facility shall be liable for action

under section 5 and section 15 of the Act, in case of any violation.

SCHEDULE I

[See rules 3 (e), 4(b), 7(1), 7(2), 7(5), 7 (6) and 8(2)]

Part-1

Biomedical wastes categories and their segregation, collection, treatment, processing and

disposal options

Category Type of Waste Type of Bag or

Container to be

used

Treatment and Disposal options

(1) (2) (3) (4)

Yellow (a) Human Anatomical

Waste: Human tissues, organs,

body parts and fetus

below the viability

period (as per the

Medical Termination of

Pregnancy Act 1971,

amended from time to

time).

Yellow coloured

non-chlorinated

plastic bags

Incineration or Plasma Pyrolysis or

deep burial*

(b)Animal Anatomical

Waste : Experimental animal

carcasses, body parts,

organs, tissues,

including the waste

generated from

animals used in

experiments or testing

in veterinary hospitals

or colleges or animal

houses.

(c) Soiled Waste: Items contaminated

with blood, body fluids

like dressings, plaster

casts, cotton swabs and

Incineration or Plasma Pyrolysis or

deep burial*

In absence of above facilities,

autoclaving or micro-waving/


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bags containing residual

or discarded blood and

blood components.

hydroclaving followed by shredding or

mutilation or combination of

sterilization and shredding. Treated

waste to be sent for energy recovery.

(d) Expired or

Discarded Medicines: Pharmaceutical waste

like antibiotics,

cytotoxic drugs

including all items

contaminated with

cytotoxic drugs along

with glass or plastic

ampoules, vials etc.

Yellow coloured

non-chlorinated

plastic bags or

containers

Expired `cytotoxic drugs and items

contaminated with cytotoxic drugs to be

returned back to the manufacturer or

supplier for incineration at temperature

>1200 0C or to common bio-medical

waste treatment facility or hazardous

waste treatment, storage and disposal

facility for incineration at >12000C Or

Encapsulation or Plasma Pyrolysis at

>12000C.

All other discarded medicines shall be

either sent back to manufacturer or

disposed by incineration.

(e) Chemical Waste:

Chemicals used in

production of biological

and used or discarded

disinfectants.

Yellow coloured

containers or

non-chlorinated

plastic bags

Disposed of by incineration or Plasma

Pyrolysis or Encapsulation in

hazardous waste treatment, storage and

disposal facility.

(f) Chemical Liquid

Waste : Liquid waste generated

due to use of chemicals

in production of

biological and used or

discarded disinfectants,

Silver X-ray film

developing liquid,

discarded Formalin,

infected secretions,

aspirated body

fluids, liquid from

laboratories and floor

washings, cleaning,

house-keeping and

disinfecting activities

etc.

Separate

collection

system leading

to effluent

treatment system

After resource recovery, the chemical

liquid waste shall be pre-treated before

mixing with other wastewater. The

combined discharge shall conform to

the discharge norms given in Schedule-

III.

(g) Discarded linen,

mattresses, beddings

contaminated with

blood or body fluid.

Non-chlorinated

yellow plastic

bags or suitable

packing material

Non- chlorinated chemical disinfection

followed by incineration or Plazma

Pyrolysis or for energy recovery.

In absence of above facilities, shredding

or mutilation or combination of


waste to be sent for energy recovery or

incineration or Plazma Pyrolysis.


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(h) Microbiology,

Biotechnology and

other clinical

laboratory waste: Blood bags, Laboratory

cultures, stocks or

specimens of micro-

organisms, live or

attenuated vaccines,

human and animal cell

cultures used in

research, industrial

laboratories, production

of biological, residual

toxins, dishes and

devices used for

cultures.

Autoclave safe

plastic bags or

containers

Pre-treat to sterilize with non-

chlorinated chemicals on-site as per

National AIDS Control Organisation or

World Health Organisation guidelines

thereafter for Incineration.

Red Contaminated Waste

(Recyclable) (a) Wastes generated

from disposable items

such as tubing, bottles,

intravenous tubes and

sets, catheters, urine

bags, syringes (without

needles and fixed needle

syringes) and

vaccutainers with their

needles cut) and gloves.

Red coloured

non-chlorinated

plastic bags or

containers

Autoclaving or micro-waving/

hydroclaving followed by shredding or

mutilation or combination of


waste to be sent to registered or

authorized recyclers or for energy

recovery or plastics to diesel or fuel oil

or for road making, whichever is

possible.

Plastic waste should not be sent to

landfill sites.

White

(Translucent) Waste sharps

including Metals: Needles, syringes with

fixed needles, needles

from needle tip cutter or

burner, scalpels, blades,

or any other

contaminated sharp

object that may cause

puncture and cuts. This

includes both used,

discarded and

contaminated metal

sharps

Puncture proof,

Leak proof,

tamper proof

containers

Autoclaving or Dry Heat Sterilization

followed by shredding or mutilation or

encapsulation in metal container or

cement concrete; combination of

shredding cum autoclaving; and sent for

final disposal to iron foundries (having

consent to operate from the State

Pollution Control Boards or Pollution

Control Committees) or sanitary

landfill or designated concrete waste

sharp pit.

Blue (a) Glassware: Broken or discarded and

contaminated glass

including medicine vials

and ampoules except

those contaminated with

cytotoxic wastes.

Cardboard boxes

with blue

colored marking

Disinfection (by soaking the washed

glass waste after cleaning with

detergent and Sodium Hypochlorite

treatment) or through autoclaving or

microwaving or hydroclaving and then

sent for recycling.


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(b) Metallic Body

Implants

Cardboard boxes

with blue

colored marking

*Disposal by deep burial is permitted only in rural or remote areas where there is no access to

common bio-medical waste treatment facility. This will be carried out with prior approval from the

prescribed authority and as per the Standards specified in Schedule-III. The deep burial facility

shall be located as per the provisions and guidelines issued by Central Pollution Control Board

from time to time.

Part -2

(1) All plastic bags shall be as per BIS standards as and when published, till then the prevailing Plastic

Waste Management Rules shall be applicable.

(2) Chemical treatment using at least 10% Sodium Hypochlorite having 30% residual chlorine for

twenty minutesor any other equivalent chemical reagent that should demonstrate Log104 reduction

efficiency for microorganisms as given in Schedule- III.

(3) Mutilation or shredding must be to an extent to prevent unauthorized reuse.

(4) There will be no chemical pretreatment before incineration, except for microbiological, lab and

highly infectious waste.

(5) Incineration ash (ash from incineration of any bio-medical waste) shall be disposed through

hazardous waste treatment, storage and disposal facility, if toxic or hazardous constituents are

present beyond the prescribed limits as given in the Hazardous Waste (Management, Handling and

Transboundary Movement) Rules, 2008 or as revised from time to time.

(6) Dead Fetus below the viability period (as per the Medical Termination of Pregnancy Act 1971,

amended from time to time) can be considered as human anatomical waste. Such waste should be

handed over to the operator of common bio-medical waste treatment and disposal facility in yellow

bag with a copy of the official Medical Termination of Pregnancy certificate from the Obstetrician

or the Medical Superintendent of hospital or healthcare establishment.

(7) Cytotoxic drug vials shall not be handed over to unauthorised person under any circumstances.

These shall be sent back to the manufactures for necessary disposal at a single point. As a second

option, these may be sent for incineration at common bio-medical waste treatment and disposal

facility or TSDFs or plasma pyrolys is at temperature >1200 0C.

(8) Residual or discarded chemical wastes, used or discarded disinfectants and chemical sludge can be

disposed at hazardous waste treatment, storage and disposal facility. In such case, the waste should

be sent to hazardous waste treatment, storage and disposal facility through operator of common

bio-medical waste treatment and disposal facility only.


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(9) On-site pre-treatment of laboratory waste, microbiological waste, blood samples, blood bags

should be disinfected or sterilized as per the Guidelines of World Health Organisation or National

AIDS Control Organisation and then given to the common bio-medical waste treatment and

disposal facility.

(10) Installation of in-house incinerator is not allowed. However in case there is no common biomedical

facility nearby, the same may be installed by the occupier after taking authorisation from the State

Pollution Control Board.

(11) Syringes should be either mutilated or needles should be cut and or stored in tamper proof, leak

proof and puncture proof containers for sharps storage. Wherever the occupier is not linked to a

disposal facility it shall be the responsibility of the occupier to sterilize and dispose in the manner

prescribed.

(12) Bio-medical waste generated in households during healthcare activities shall be segregated as per

these rules and handed over in separate bags or containers to municipal waste collectors. Urban

Local Bodies shall have tie up with the common bio-medical waste treatment and disposal facility

to pickup this waste from the Material Recovery Facility (MRF) or from the house hold directly,

for final disposal in the manner as prescribed in this Schedule.

SCHEDULE II

[See rule 4(t), 7(1) and 7(6)]

STANDARDS FOR TREATMENT AND DISPOSAL OF

BIO-MEDICALWASTES

1. STANDARDS FOR INCINERATION.-

All incinerators shall meet the following operating and emission standards-

A. Operating Standards

1). Combustion efficiency (CE) shall be at least 99.00%.

2). The Combustion efficiency is computed as follows:

%C02

C.E. = ------------ X 100

%C02 + % CO

3). The temperature of the primary chamber shall be a minimum of 800 0C and the secondary

chamber shall be minimum of 10500C + or - 50

0C.

4). The secondary chamber gas residence time shall be at least two seconds.

B. Emission Standards


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Sl.

No.

Parameter Standards

(1) (2) (3) (4)

Limiting concentration

in mg Nm3

unless

stated

Sampling Duration in minutes,

unless stated

1. Particulate matter 50 30 or 1NM3 of sample volume,

whichever is more

2. Nitrogen Oxides NO and

NO2 expressed asNO2

400 30 for online sampling or grab

sample

3. HCl 50 30 or 1NM3

of sample volume,

whichever is more

4. Total Dioxins and Furans 0.1ngTEQ/Nm3 (at 11%

O2)

8 hours or 5NM3 of sample volume,

whichever is more

5. Hg and its compounds 0.05 2 hours or 1NM3 of sample volume,

whichever is more

C. Stack Height: Minimum stack height shall be 30 meters above the ground and shall be attached with

the necessary monitoring facilities as per requirement of monitoring of ‘general parameters’ as notified

under the Environment (Protection) Act, 1986 and in accordance with the Central Pollution Control

Board Guidelines of Emission Regulation Part-III.

Note:

(a) The existing incinerators shall comply with the above within a period of two years from the date of

the notification.

(b) The existing incinerators shall comply with the standards for Dioxins and Furans of 0.1ngTEQ/Nm3,

as given below within two years from the date of commencement of these rules.

(c) All upcoming common bio-medical waste treatment facilities having incineration facility or captive

incinerator shall comply with standards for Dioxins and Furans.

(d) The existing secondary combustion chambers of the incinerator and the pollution control devices shall

be suitably retrofitted, if necessary, to achieve the emission limits.

(e) Wastes to be incinerated shall not be chemically treated with any chlorinated disinfectants.

(f) Ash from incineration of biomedical waste shall be disposed of at common hazardous waste treatment

and disposal facility. However, it may be disposed of in municipal landfill, if the toxic metals in

incineration ash are within the regulatory quantities as defined under the Hazardous Waste

(Management and Handling and Transboundary Movement) Rules, 2008 as amended from time to

time.

(g) Only low Sulphur fuel like Light Diesel Oil or Low Sulphur Heavy Stock or Diesel, Compressed

Natural Gas, Liquefied Natural Gas or Liquefied Petroleum Gas shall be used as fuel in the

incinerator.


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(h) The occupier or operator of a common bio-medical waste treatment facility shall monitor the stack

gaseous emissions (under optimum capacity of the incinerator) once in three months through a

laboratory approved under the Environment (Protection) Act, 1986 and record of such analysis

results shall be maintained and submitted to the prescribed authority. In case of dioxins and furans,

monitoring should be done once in a year.

(i) The occupier or operator of the common bio-medical waste treatment facility shall install continuous

emission monitoring system for the parameters as stipulated by State Pollution Control Board or

Pollution Control Committees in authorisation and transmit the data real time to the servers at State

Pollution Control Board or Pollution Control Committees and Central Pollution Control Board.

(j) All monitored values shall be corrected to 11% Oxygen on dry basis.

(k) Incinerators (combustion chambers) shall be operated with such temperature, retention time and

turbulence, as to achieve Total Organic Carbon content in the slag and bottom ashes less than 3% or

their loss on ignition shall be less than 5% of the dry weight.

(l) The occupier or operator of a common bio-medical waste incinerator shall use combustion gas

analyzer to measure CO2, CO and O2.

2. Operating and Emission Standards for Disposal by Plasma Pyrolysis or Gasification:

A. Operating Standards:

All the operators of the Plasma Pyrolysis or Gasification shall meet the following operating and emission

standards:

1) Combustion Efficiency (CE) shall be at least 99.99%.

2) The Combustion Efficiency is computed as follows.

% CO2 C.E =

……………………… X 100

(% CO2 + % CO)

3) The temperature of the combustion chamber after plasma gasification shall be 1050 ± 50 o C with

gas residence time of at least 2(two) second, with minimum 3 % Oxygen in the stack gas.

4) The Stack height should be minimum of 30 m above ground level and shall be attached with the

necessary monitoring facilities as per requirement of monitoring of ‘general parameters’ as

notified under the Environment (Protection) Act, 1986 and in accordance with the CPCB

Guidelines of Emission Regulation Part-III.

B. Air Emission Standards and Air Pollution Control Measures

(i) Emission standards for incinerator, notified at Sl No.1 above in this Schedule, and revised from

time to time, shall be applicable for the Plasma Pyrolysis or Gasification also.


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(ii) Suitably designed air pollution control devices shall be installed or retrofitted with the ‘Plasma

Pyrolysis or Gasification to achieve the above emission limits, if necessary.

(iii) Wastes to be treated using Plasma Pyrolysis or Gasification shall not be chemically treated with

any chlorinated disinfectants and chlorinated plastics shall not be treated in the system.

C. Disposal of Ash Vitrified Material: The ash or vitrified material generated from the ‘Plasma

Pyrolysis or Gasification shall be disposed off in accordance with the Hazardous Waste (Management,

Handling and Transboundary Movement) Rules 2008 and revisions made thereafter in case the

constituents exceed the limits prescribed under Schedule II of the said Rules or else in accordance with

the provisions of the Environment (Protection) Act, 1986, whichever is applicable.

3. STANDARDS FOR AUTOCLAVING OF BIO-MEDICAL WASTE.-

The autoclave should be dedicated for the purposes of disinfecting and treating bio-medical

waste.

(1) When operating a gravity flow autoclave, medical waste shall be subjected to:

(i) a temperature of not less than 121° C and pressure of 15 pounds per square inch (psi) for an

autoclave residence time of not less than 60 minutes; or

(ii) a temperature of not less than 135° C and a pressure of 31 psi for an autoclave residence time of

not less than 45 minutes; or

(iii) a temperature of not less than 149° C and a pressure of 52 psi for an autoclave residence time

of not less than 30 minutes.

(2) When operating a vacuum autoclave, medical waste shall be subjected to a minimum of three

pre-vacuum pulse to purge the autoclave of all air. The air removed during the pre-vacuum, cycle should

be decontaminated by means of HEPA and activated carbon filtration, steam treatment, or any other

method to prevent release of pathogen. The waste shall be subjected to the following:

(i) a temperature of not less than 121°C and pressure of 15 psi per an autoclave residence time of

not less than 45 minutes; or

(ii) a temperature of not less than 135°C and a pressure of 31 psi for an autoclave residence time of

not less than 30 minutes;

(3) Medical waste shall not be considered as properly treated unless the time, temperature and

pressure indicators indicate that the required time, temperature and pressure were reached during the

autoclave process. If for any reasons, time temperature or pressure indicator indicates that the required

temperature, pressure or residence time was not reached, the entire load of medical waste must be

autoclaved again until the proper temperature, pressure and residence time were achieved.


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(4) Recording of operational parameters: Each autoclave shall have graphic or computer recording

devices which will automatically and continuously monitor and record dates, time of day, load

identification number and operating parameters throughout the entire length of the autoclave cycle.

(5) Validation test for autoclave: The validation test shall use four biological indicator strips, one shall

be used as a control and left at room temperature, and three shall be placed in the approximate center of

three containers with the waste. Personal protective equipment (gloves, face mask and coveralls) shall be

used when opening containers for the purpose of placing the biological indicators. At least one of the

containers with a biological indicator should be placed in the most difficult location for steam to

penetrate, generally the bottom center of the waste pile. The occupier or operator shall conduct this test

three consecutive times to define the minimum operating conditions. The temperature, pressure and

residence time at which all biological indicator vials or strips for three consecutive tests show complete

inactivation of the spores shall define the minimum operating conditions for the autoclave. After

determining the minimum temperature, pressure and residence time, the occupier or operator of a

common biomedical waste treatment facility shall conduct this test once in three months and records in

this regard shall be maintained.

(6) Routine Test: A chemical indicator strip or tape that changes colour when a certain temperature is

reached can be used to verify that a specific temperature has been achieved. It may be necessary to use

more than one strip over the waste package at different locations to ensure that the inner content of the

package has been adequately autoclaved. The occupier or operator of a common bio medical waste

treatment facility shall conduct this test during autoclaving of each batch and records in this regard shall

be maintained.

(7) Spore testing: The autoclave should completely and consistently kill the approved biological

indicator at the maximum design capacity of each autoclave unit. Biological indicator for autoclave shall

be Geobacillusstearothermophilus spores using vials or spore Strips; with at least 1X106 spores. Under no

circumstances will an autoclave have minimum operating parameters less than a residence time of 30

minutes, a temperature less than 121o C or a pressure less than 15 psi. The occupier or operator of a

common bio medical waste treatment and disposal facility shall conduct this test at least once in every

week and records in this regard shall be maintained.

4. STANDARDS OF MICROWAVING.-

(1) Microwave treatment shall not be used for cytotoxic, hazardous or radioactive wastes,

contaminated animal carcasses, body parts and large metal items.

(2) The microwave system shall comply with the efficacy test or routine tests and a performance

guarantee may be provided by the supplier before operation of the limit.

(3) The microwave should completely and consistently kill the bacteria and other pathogenic

organisms that are ensured by approved biological indicator at the maximum design capacity of each

microwave unit. Biological indicators for microwave shall be Bacillus atrophaeusspores using vials or

spore strips with at least 1 x 104sporesper detachable strip. The biological indicator shall be placed with

waste and exposed to same conditions as the waste during a normal treatment cycle.


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5. STANDARDS FOR DEEP BURIAL.- (1) A pit or trench should be dug about two meters deep.

It should be half filled with waste, then covered with lime within 50 cm of the surface, before filling the

rest of the pit with soil.

(2) It must be ensured that animals do not have any access to burial sites. Covers of galvanised iron

or wire meshes may be used.

(3) On each occasion, when wastes are added to the pit, a layer of 10 cm of soil shall be added to

cover the wastes.

(4) Burial must be performed under close and dedicated supervision.

(5) The deep burial site should be relatively impermeable and no shallow well should be close to the

site.

(6) The pits should be distant from habitation, and located so as to ensure that no contamination

occurs to surface water or ground water. The area should not be prone to flooding or erosion.

(7) The location of the deep burial site shall be authorised by the prescribed authority.

(8) The institution shall maintain a record of all pits used for deep burial.

(9) The ground water table level should be a minimum of six meters below the lower level of deep

burial pit.

6. STANDARDS FOR EFFICACY OF CHEMICAL DISINFECTION

Microbial inactivation efficacy is equated to “Log10 kill” which is defined as the difference

between the logarithms of number of test microorganisms before and after chemical treatment. Chemical

disinfection methods shall demonstrate a 4 Log10 reduction or greater for Bacillus Subtilis (ATCC

19659) in chemical treatment systems.

7. STANDARDS FOR DRY HEAT STERILIZATION

Waste sharps can be treated by dry heat sterilization at a temperature not less than 1850C, at least

for a residence period of 150 minutes in each cycle, which sterilization period of 90 minutes. There

should be automatic recording system to monitor operating parameters.

(i) Validation test for Shaprs sterilization unit

Waste shaprs sterilization unit should completely and consistently kill the biological indicator

GeobacillusStearothermophillus or Bacillus Atropheausspoers using vials with at least log10 6 spores per

ml. The test shall be carried out once in three months

(ii) Routine test


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A chemical indicator strip or tape that changes colour when a certain temperature is reached can

be used to verify that a specific temperature has been achieved. It may be necessary to use more than one

strip over the waste to ensure that the inner content of the sharps has been adequately disinfected. This

test shall be performed once in week and records in this regard shall be maintained.

8. STANDARDS FOR LIQUID WASTE.-

(1) The effluent generated or treated from the premises of occupier or operator of a common bio

medical waste treatment and disposal facility, before discharge into the sewer should conform to the

following limits-

PARAMETERS PERMISSIBLE LIMITS

pH 6.5-9.0

Suspended solids 100 mg/l

Oil and grease 10 mg/l

BOD 30 mg/l

COD 250 mg/l

Bio-assay test 90% survival of fish after 96 hours in 100% effluent.

(2) Sludge from Effluent Treatment Plant shall be given to common bio-medical waste treatment facility

for incineration or to hazardous waste treatment, storage and disposal facility for disposal.

Schedule III

[See rule 6 and 9(3)]

List of Prescribed Authorities and the Corresponding Duties

Sl.

No

.

(1)

Authority

(2)

Corresponding Duties

(3)

1 Ministry of Environment, Forest

and Climate Change, Government

of India

(i) Making Policies concerning bio-medical waste

Management in the Country including notification

of Rules and amendments to the Rules as and

when required.

(ii) Providing financial assistance for training and

awareness programmes on bio-medical waste

management related activities to for the State

Pollution Control Boards or Pollution Control

Committees.

(iii) Facilitating financial assistance for setting up or

up-gradation of common bio-medical waste

treatment facilities.

(iv) Undertake or support operational research and

assessment with reference to risks to environment

and health due to bio-medical waste and


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previously unknown disposables and wastes from

new types of equipment.

(v) Constitution of Monitoring Committee for

implementation of the rules.

(vi) Hearing Appeals and give decision made in Form-

V against order passed by the prescribed

authorities.

(vii) Develop Standard manual for Trainers and

Training.

(viii) Notify the standards or operating parameters for

new technologies for treatment of bio medical

waste other than those listed in Schedule- I.

2 Central or State Ministry of Health

and Family Welfare, Central

Ministry for Animal Husbandry

and Veterinary or State Department

of Animal Husbandry and

Veterinary.

(i) Grant of license to health care facilities or nursing

homes or veterinary establishments with a condition

to obtain authorisation from the prescribed authority

for bio-medical waste management.

(ii) Monitoring, Refusal or Cancellation of license for

health care facilities or nursing homes or veterinary

establishments for violations of conditions of

authorisation or provisions under these Rules.

(iii) Publication of list of registered health care facilities

with regard to bio-medical waste generation,

treatment and disposal.

(iv) Undertake or support operational research and

assessment with reference to risks to environment

and health due to bio-medical waste and previously

unknown disposables and wastes from new types of

equipment.

(v) Coordinate with State Pollution Control Boards for

organizing training programmes to staff of health

care facilities and municipal workers on bio-medical

waste.

(vi) Constitution of Expert Committees at National or

State level for overall review and promotion of clean

or new technologies for bio-medical waste

management.


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(vii) Organizing or Sponsoring of trainings for the

regulatory authorities and health care facilities on

bio-medical waste management related activities.

(viii) Sponsoring of mass awareness campaigns in

electronic media and print media.

3 Ministry of Defence (i) Grant and renewal of authorisation to Armed Forces

health care facilities or common bio-medical waste

treatment facilities (Rule 9).

(ii) Conduct training courses for authorities dealing with

management of bio-medical wastes in Armed Forces

health care facilities or treatment facilities in

association with State Pollution Control Boards or

Pollution Control Committees or Central Pollution

Control Board or Ministry of Environment, Forest

and Climate Change.

(iii) Publication of inventory of occupiers and bio-

medical waste generation from Armed Forces health

care facilities or occupiers

(iv) Constitution of Advisory Committee for

implementation of the rules.

(v) Review of management of bio-medical waste

generation in the Armed Forces health care facilities

through its Advisory Committee (Rule 11).

(vi) Submission of annual report to Central Pollution

Control Board within the stipulated time period (Rule

13).

4. Central Pollution Control Board (i) Prepare Guidelines on bio-medical waste

Management and submit to the Ministry of

Environment, Forest and Climate Change.

(ii) Co-ordination of activities of State Pollution Control

Boards or Pollution Control Committees on bio-

medical waste.

(iii) Conduct training courses for authorities dealing with

management of bio-medical waste.

(iv) Lay down standards for new technologies for


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treatment and disposal of bio-medical waste (Rule 7)

and prescribe specifications for treatment and

disposal of bio-medical wastes (Rule 7).

(v) Lay down Criteria for establishing common bio-

medical waste treatment facilities in the Country.

(vi) Random inspection or monitoring of health care

facilities and common bio-medical waste treatment

facilities.

(vii) Review and analysis of data submitted by the State

Pollution Control Boards on bio-medical waste and

submission of compiled information in the form of

annual report along with its observations to Ministry

of Environment, Forest and Climate Change .

(viii) Inspection and monitoring of health care facilities

operated by the Director General, Armed Forces

Medical Services (Rule 9).

(ix) Undertake or support research or operational

research regarding bio-medical waste.

5. State Government of Health or

Union Territory Government or

Administration

(i) To ensure implementation of the rule in all health

care facilities or occupiers.

(ii) Allocation of adequate funds to Government health

care facilities for bio-medical waste management.

(iii) Procurement and allocation of treatment equipments

and make provision for consumables for bio-medical

waste management in Government health care

facilities.

(iv) Constitute State or District Level Advisory

Committees under the District Magistrate or

Additional District Magistrate to oversee the bio-

medical waste management in the Districts.

(v) Advise State Pollution Control Boards or Pollution

Control Committees on implementation of these

Rules.

(vi) Implementation of recommendations of the Advisory

Committee in all the health care facilities.


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6. State Pollution Control Boards or

Pollution Control Committees

(i) Inventorisation of Occupiers and data on bio-medical

waste generation, treatment & disposal.

(ii) Compilation of data and submission of the same in

annual report to Central Pollution Control Board

within the stipulated time period.

(iii) Grant and renewal, suspension or refusal cancellation

or of authorisation under these rules (Rule 7, 8 and

10).

(iv) Monitoring of compliance of various provisions and

conditions of authorisation.

(v) Action against health care facilities or common bio-

medical waste treatment facilities for violation of

these rules (Rule 18).

(vi) Organizing training programmes to staff of health

care facilities and common bio-medical waste

treatment facilities and State Pollution Control

Boards or Pollution Control Committees Staff on

segregation, collection, storage, transportation,

treatment and disposal of bio-medical wastes.

(vii) Undertake or support research or operational research

regarding bio-medical waste management.

(viii) Any other function under these rules assigned by

Ministry of Environment, Forest and Climate

Change or Central Pollution Control Board from

time to time.

(ix) Implementation of recommendations of the Advisory

Committee.

(x) Publish the list of Registered or Authorised (or give

consent) Recyclers.

(xi) Undertake and support third party audits of the

common bio-medical waste treatment facilities in

their State.

7 Municipalities or Corporations,

Urban Local Bodies and Gram

Panchayats

(i) Provide or allocate suitable land for development of

common bio-medical waste treatment facilities in

their respective jurisdictions as per the guidelines of


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Central Pollution Control Board.

(ii) Collect other solid waste (other than the bio-

medical waste) from the health care facilities as

per the Municipal Solid Waste ( Management and

handling) Rules, 2000 or as amended time to time.

(iii) Any other function stipulated under these Rules.


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SCHEDULE IV

[See rule 8(3) and (5)]

Part A

LABEL FOR BIO-MEDICAL WASTE CONTAINERS or BAGS

CYTOTOXIC HAZARDSYMBOL

HANDLE WITH CARE HANDLE WITH CARE

Part B

LABEL FOR TRANSPORTING BIO-MEDICAL WASTE BAGS OR CONTAINERS

Day ............Month ..............

Year ...........

Date of generation ...................

Waste category Number ........

Waste quantity…………

Sender's Name and Address Receiver's Name and Address:

Phone Number ........ Phone Number ...............

Fax Number............... Fax Number .................

Contact Person ........ Contact Person .........

In case of emergency please contact :

Name and Address :

Phone No.

Note :Label shall be non-washable and prominently visible.

FORM – I

[ (See rule 4(o), 5(i) and 15 (2)]

ACCIDENT REPORTING

1. Date and time of accident :

2. Type of Accident :


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3. Sequence of events leading to accident :

4. Has the Authority been informed immediately :

5. The type of waste involved in accident :

6. Assessment of the effects of the

accidents on human health and the environment:

7. Emergency measures taken :

8. Steps taken to alleviate the effects of accidents :

9. Steps taken to prevent the recurrence of such an accident :

10. Does you facility has an Emergency Control policy? If yes give details:

Date : …………………… Signature …………………….

Place: …………………… Designation …………………..

FORM - II

(See rule10)

APPLICATION FOR AUTHORISATION OR RENEWAL OF AUTHORISATION

(To be submitted by occupier of health care facility or common bio-medical waste treatment facility)

To

The Prescribed Authority

(Name of the State or UT Administration)

Address.

1. Particulars of Applicant:

(i) Name of the Applicant:

(In block letters & in full)

(ii) Name of the health care facility (HCF) or common bio-medical waste treatment facility

(CBWTF) :

(iii) Address for correspondence:

(iv) Tele No., Fax No.:


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(v) Email:

(vi) Website Address:

2. Activity for which authorisation is sought:

Activity Please tick

Generation, segregation

Collection,

Storage

packaging

Reception

Transportation

Treatment or processing or conversion

Recycling

Disposal or destruction

use

offering for sale, transfer

Any other form of handling

3. Application for □ fresh or □ renewal of authorisation (please tick whatever is applicable):

(i) Applied for CTO/CTE Yes/No

(ii) In case of renewal previous authorisation number and date:

------------------------------------------------------

(iii) Status of Consents:

(a) under the Water (Prevention and Control of Pollution) Act, 1974

------------------------------------------------------

(b) under the Air (Prevention and Control of Pollution) Act, 1981:

------------------------------------------------------

4. (i) Address of the health care facility (HCF) or common bio-medical waste treatment facility

(CBWTF):

(ii) GPS coordinates of health care facility (HCF) or common bio-medical waste treatment

facility (CBWTF):

5. Details of health care facility (HCF) or common bio-medical waste treatment facility (CBWTF):

(i) Number of beds of HCF:

(ii) Number of patients treated per month by HCF:

(iii) Number healthcare facilities covered by CBMWTF: ______

(iv) No of beds covered by CBMWTF: ______

(v) Installed treatment and disposal capacity of CBMWTF:_______ Kg per day

(vi) Quantity of biomedical waste treated or disposed by CBMWTF:_____ Kg/ day

(vii) Area or distance covered by CBMWTF:______________


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(pl. attach map a map with GPS locations of CBMWTF and area of coverage)

(viii) Quantity of Biomedical waste handled, treated or disposed:

Category Type of Waste Quantity

Generated or

Collected, kg/day

Method of

Treatment and

Disposal

(Refer Schedule-

I)

(1) (2) (3) (4)

Yellow

(a) Human Anatomical Waste:

(b)Animal Anatomical Waste :

(c) Soiled Waste:

(d) Expired or Discarded Medicines:

(e) Chemical Solid Waste:

(f) Chemical Liquid Waste :

(g) Discarded linen, mattresses, beddings

contaminated with blood or body fluid.

(h) Microbiology, Biotechnology and other

clinical laboratory waste:

Red Contaminated Waste (Recyclable)

White

(Translucen

t)

Waste sharps including Metals:

Blue Glassware:

Metallic Body Implants

6. Brief description of arrangements for handling of biomedical waste (attach details):

(i) Mode of transportation (if any) of bio-medical waste:

(ii) Details of treatment equipment (please give details such as the number, type & capacity

of each unit)

No of units Capacity of each unit

Incinerators :

Plasma Pyrolysis:

Autoclaves:

Microwave:

Hydroclave:

Shredder:

Needle tip cutter or

destroyer

Sharps encapsulation or

concrete pit:

Deep burial pits:

Chemical disinfection:

Any other treatment

equipment:


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7. Contingency plan of common bio-medical waste treatment facility (CBWTF)(attach documents):

8. Details of directions or notices or legal actions if any during the period of earlier authorisation

9. Declaration

I do hereby declare that the statements made and information given above are true to the best of my

knowledge and belief and that I have not concealed any information.

I do also hereby undertake to provide any further information sought by the prescribed authority in

relation to these rules and to fulfill any conditions stipulated by the prescribed authority.

Date : Signature of the Applicant

Place : Designation of the Applicant

FORM –III

(See rule 10)

AUTHORISATION

(Authorisation for operating a facility for generation, collection, reception, treatment, storage, transport

and disposal of biomedical wastes)

1. File number of authorisation and date of issue……………………………………….

2. M/s __________________ an occupier or operator of the facility located at

______________________ is hereby granted an authorisation for;

Activity Please tick

Generation, segregation

Collection,

Storage

packaging

Reception

Transportation

Treatment or processing or conversion

Recycling

Disposal or destruction

use

offering for sale, transfer

Any other form of handling

3. M/s _____________________________ is hereby authorized for handling of biomedical waste

as per the capacity given below;

(i) Number of beds of HCF:

(ii) Number healthcare facilities covered by CBMWTF: ______


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(iii) Installed treatment and disposal capacity:_______ Kg per day

(iv) Area or distance covered by CBMWTF:______________

________________________________________________

(v) Quantity of Biomedical waste handled, treated or disposed:

Type of Waste Category Quantity permitted for

Handling

Yellow

Red

White (Translucent)

Blue

3. This authorisation shall be in force for a period of …………. Years from the date of issue.

4. This authorisation is subject to the conditions stated below and to such other conditions as may

be specified in the rules for the time being in force under the Environment (Protection) Act, 1986.

Date ……………. Signature……………………..

Place: ………………… Designation …………………..

Terms and conditions of authorisation *

1. The authorisation shall comply with the provisions of the Environment (Protection) Act, 1986

and the rules made there under.

2. The authorisation or its renewal shall be produced for inspection at the request of an officer

authorised by the prescribed authority.

3. The person authorized shall not rent, lend, sell, transfer or otherwise transport the biomedical

wastes without obtaining prior permission of the prescribed authority.

4. Any unauthorised change in personnel, equipment or working conditions as mentioned in the

application by the person authorised shall constitute a breach of his authorisation.

5. It is the duty of the authorised person to take prior permission of the prescribed authority to close

down the facility and such other terms and conditions may be stipulated by the prescribed

authority.

Form - IV

(See rule 13)

ANNUAL REPORT

[To be submitted to the prescribed authority on or before 30th June every year for the period from January

to December of the preceding year, by the occupier of health care facility (HCF) or common bio-medical

waste treatment facility (CBWTF)]

Sl.

No.

Particulars

1 . Particulars of the Occupier :

(i) Name of the authorised person (occupier or

operator of facility)

:


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34

(ii) Name of HCF or CBMWTF :

(iii) Address for Correspondence :

(iv) Address of Facility

(v)Tel. No, Fax. No :

(vi) E-mail ID :

(vii) URL of Website

(viii) GPS coordinates of HCF or CBMWTF

(ix) Ownership of HCF or CBMWTF : (State Government or Private or

Semi Govt. or any other)

(x). Status of Authorisation under the Bio-Medical

Waste (Management and Handling) Rules

: Authorisation No.:

……………………………………

………………..valid up to ………..

(xi). Status of Consents under Water Act and Air

Act

: Valid up to:

2. Type of Health Care Facility :

(i) Bedded Hospital : No. of Beds:…..

(ii) Non-bedded hospital

(Clinic or Blood Bank or Clinical Laboratory or

Research Institute or Veterinary Hospital or any

other)

:

(iii) License number and its date of expiry

3. Details of CBMWTF :

(i) Number healthcare facilities covered by

CBMWTF

:

(ii) No of beds covered by CBMWTF :

(iii) Installed treatment and disposal capacity of

CBMWTF:

: _______ Kg per day

(iv) Quantity of biomedical waste treated or disposed

by CBMWTF

: _____ Kg/day

4. Quantity of waste generated or disposed in Kg per

annum (on monthly average basis)

:

Yellow Category :

Red Category :

White:

Blue Category :

General Solid waste:

5 Details of the Storage, treatment, transportation, processing and Disposal Facility

(i) Details of the on-site storage

facility

: Size :

Capacity :

Provision of on-site storage : (cold storage or

any other provision)

(ii) Details of the treatment or :


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35

disposal facilities Type of treatment

equipment

No

of

unit

s

Cap

acit

y

Kg/

day

Quantity

treatedo

r

disposed

in kg

per

annum

Incinerators

Plasma Pyrolysis

Autoclaves

Microwave

Hydroclave

Shredder

Needle tip cutter or

destroyer

-

Sharps

encapsulation or

concrete pit

-

Deep burial pits:

Chemical

disinfection:

-

Any other treatment

equipment:

(iii) Quantity of recyclable wastes

sold to authorized recyclers after

treatment in kg per annum.

: Red Category (like plastic, glass etc.)

(iv) No of vehicles used for collection

and transportation of biomedical

waste

:

(v) Details of incineration ash and

ETP sludge generated and disposed

during the treatment of wastes in Kg

per annum

Quantity

generated

Where

disposed

Incineration

Ash

ETP Sludge

(vi) Name of the Common Bio-

Medical Waste Treatment Facility

Operator through which wastes are

disposed of

:

(vii) List of member HCF not handed

over bio-medical waste.

6 Do you have bio-medical waste

management committee? If yes, attach

minutes of the meetings held during

the reporting period

7 Details trainings conducted on BMW

(i) Number of trainings conducted on

BMW Management.


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36

(ii) number of personnel trained

(iii) number of personnel trained at

the time of induction

(iv) number of personnel not

undergone any training so far

(v) whether standard manual for

training is available?

(vi) any other information)

8 Details of the accident occurred

during the year

(i) Number of Accidents occurred

(ii) Number of the persons affected

(iii) Remedial Action taken (Please

attach details if any)

(iv) Any Fatality occurred, details.

9. Are you meeting the standards of air

Pollution from the incinerator? How

many times in last year could not met

the standards?

Details of Continuous online emission

monitoring systems installed

10

.

Liquid waste generated and treatment

methods in place. How many times

you have not met the standards in a

year?

11 Is the disinfection method or

sterilization meeting the log 4

standards? How many times you have

not met the standards in a year?

12

.

Any other relevant information

: (Air Pollution Control Devices attached with the

Incinerator)

Certified that the above report is for the period from

…………………………………………………………..…………………………………………

………………………………………………………………………………………………………

………………………………………………………………………………………………………

……………………………..

Name and Signature of the Head of the Institution

Date:

Place

FORM –V


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(See rule 16)

Application for filing appeal against order passed by the prescribed authority

1. Name and address of the person applying for appeal :

2. Number, date of order and address of the authority which passed the order, against which appeal

is being made (certified copy of order to be attached):

3. Ground on which the appeal is being made:

4. List of enclosures other than the order referred in para 2 against which appeal is being filed:

Signature ……………………..

Date : Name and Address……………………..

[F. No. 3-1/2000-HSMD]

(Bishwanath Sinha)

Joint secretary to the Government of India

******


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L.E.D. E-Journal

AERB Guidelines

The IDA Ludhiana Branch publication, ‘L.E.D.’ Ludhiana – ‘Let’s

Enjoy Dentistry’, a monthly E-Journal brings you the latest Atomic

Energy Regulatory Board (AERB) guidelines for radiographic

equipment in dental clinic & institutions in India. AERB has itself

developed and commissioned its computerized e-Governance project

“e-Licensing of Radiation Applications (e-LORA)” for Radiotherapy

facilities. This will facilitate the online submission of applications,

issuance of all regulatory clearances and registration of radiotherapy

institutions/radiation professionals. The system is being rolled out in

a phased manner by AERB and several institutes have already gone

online through e-LORA. All Radiotherapy facilities are expected to be

switched to online mode very shortly. For this purpose, all existing

radiotherapy centers are required to submit the details regarding the

following to AERB for pre-registration in e-LORA.

1. Present Employer

2. Licensee(s)

3. Radiological Safety Officer (s)

The format for details (as an excel file) can be downloaded

from AERB website as shown in the above Picture. Radiotherapy

institutions should ensure that all radiation professionals working in

the institution are registered with AERB through e-LORA. Kindly note

that AERB plans to stop accepting paper based regulatory

applications w.e.f. December 01, 2013 and all regulatory clearances

will be issued based on electronic submissions through e-LORA only.

The guidelines and all the needed details & forms are attached along

with.


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http://www.aerb.gov.in/

Guidelines

GUIDELINES FOR STARTING A DIAGNOSTIC X-RAY INSTALLATION(Applicable for Diagnostic X-Ray/Cathlab/CTScan/C-Arm/Mammography/Dental/OPG/BMD/Mobile Units)

As per Atomic Energy (Radiation Protection) Rules 2004 Section (3) a Licence / Registration isnecessary for establishing a radiation installation. This process involves 3 steps. (i) SiteApproval by DRS (ii) Quality Assurance Test by manufacturer/supplier under intimation to DRS(iii) Licence/Registration by AERB through DRS.

1. Submit completely filled and duly signed “Application for Site Approval of X-Ray InstallationLayout” along with layout plan of the diagnostic x-ray room, drawn to scale 1:50 showing detailsas described in the application form, in original with two copies for approval to the Director,Directorate of Radiation Safety, District Hospital Compound, Thrissur. Pin: 680 001. Separateform should be submitted for each medical diagnostic x-ray unit installation. Mobile units do notrequire plan approval (mobile units should not be used in a room with table) but needRegistration Certificate. Enclose fees in the form of Demand Draft drawn in favour of theDirector of Radiation Safety payable at Thrissur, at the rates prescribed by theGovdownernment.

2. The room housing an x-ray unit shall not be less than 18m2 for general-purposeradiography and conventional fluoroscopy equipment and no single dimension of the x-ray roomshall be less than 4.0m. The room housing the gantry of the computed tomography (CT Scan)unit shall not be less than 25 m 15

and no single dimension of the gantry of CT Scan room shall be less than 4m. The roomhousing an orthopan tomography (OPG) units shall not be less that 15 m2

and no single dimension of the OPG room shall be less than 3.5m. The room housing amammography x-ray unit shall not be less than 10 m2

and no single dimension of x-ray room shall be less than 3m. Also, not more than one unit ofany type shall be installed in the same room. The minimum wall thickness of the x-ray roomshould be 9 inch or 23cm solid brick or equivalent. There shall be no windows and ventilationsshall be above 2m from the floor outside. Table shall be oriented such that the primary (cheststand) is not directed towards the main door or darkroom. The primary wall thickness shall be35 cm of solid brick or 32 cm solid brick + 1.5 mm LEAD

3. The users should install only Atomic Energy Regulatory Board (AERB) “Type Approved”unit or unit with valid NOC for medical diagnostic purpose and obtain a copy of the AERB “Type

1 / 3Vol. 1 Issue 11 L.E.D. E-Journal

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Guidelines

Approval” certificate from the supplier/manufacturer of the x-ray unit prior to the procurement ofthe unit. User may verify the Type Approval Certificate Number from AERB in case of anydoubt.

4. The users should procure and use protective accessories such as mobile protective barrier,lead rubber aprons, lead rubber flaps, gloves, thyroid shields, etc.

5. The employer shall provide Personnel Monitoring Badges to all radiation workers of theinstitute. For procuring personnel monitoring badges, please contact Avanttec LaboratoriesPrivate Limited, #31, Kamaraj Street, Srinivasa Nagar, Padi, Chennai-600 050.

6. The users should follow the guidelines given in AERB Safety Code for Medical DiagnosticX-Ray Equipment and Installations [Code No.AERB/SC/MED-2 (Rev.-1)]. The same can bepurchased from AERB or downloaded from AERB website www.aerb.gov.in. The user shallcomply with other regulatory documents related to the use and operation of x-ray units that areavailable in AERB website or DRS website.

i Atomic Energy (Radiation Protection) Rules, 2004 (G.S.R.303)

ii Radiation Surveillance Procedures for Medical Applications of Radiation, 1989(G.S.R.No.388)

iii Performa for “Registration of Diagnostic X-Ray installations and Licence of ComputedTomography (CT)/Cathlab unit Installations”.

iv Documents (i) & (ii) can be purchased from bookstalls selling government publications or canbe downloaded from DRS website. (iii) shall be given by the Directorate of Radiation Safety onSite Approval

7. The users should request the supplier/manufacturer of the diagnostic x-ray units to conductQuality Assurance (QA) tests after the installation of x-ray unit/computed tomographyunit/mammography/ cathlab unit prior to using it for patient diagnosis, under intimation to theDRS. Preserve the QA tests report in the hospital/institution record for further use and submit acopy of QA tests report to the DRS. The unit should be used for patient diagnosis only if itsperformance is found satisfactory.

8. After installation, the users should send the completely filled and duly signed “Applicationfor Registration of Diagnostic X-Ray installations” / “Application for Licence of ComputedTomography (CT) unit / Interventional Radiology (Cathlab) Installations” (as applicable) to theDirector, Directorate of Radiation Safety, District Hospital Compound, Thrissur -680 001 for


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Guidelines

onward transmission with recommendation to the Atomic Energy Regulatory Board for obtainingRegistration Certificate for diagnostic x-ray units and/or Licence Certificate for CT Scan/Cathlabunits for operation.

9. The employer shall employ only qualified Radiologist and x-ray Technician. The minimumqualification is given in AERB Safety Code for Medical Diagnostic X-Ray Equipment andInstallations [Code No.AERB/SC/MED-2(Rev-1)]

10. AERB issues notice every year in all leading newspapers in the country (both Hindi andEnglish) regarding “Statutory Requirements for Safe Operation of Medical diagnostic X-ray unitsby Hospitals, Clinics and other Medical Institutions in India”.


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Radiological Safety Division (RSD)

DIAGNOSTIC RADIOLOGY SECTION

Revised Guidelines for obtaining regulatory consents from AERB for

medical diagnostic X-ray equipment

1) Applications for Registration (Radiography/R &F/Mammography/OPG/BMD/ Dental/

Mobile Radiography/ C-Arm) (details given in TABLE-A):

Completely filled duly signed and stamped application form (AERB/RSD/MDX/REG).

Layout shall be prepared as per the AERB guidelines for layout and shielding of x-ray equipment

2) Application for License (Computed Tomography(CT)/ Interventional Radiology (IR)

installations) (Details given in TABLE-B)

Completely filled, duly signed and stamped application form (AERB/RSD/MDX-CT-

CATH/LCO & RSO)

Layout shall be prepared as per the AERB guidelines for layout and shielding of x-ray

equipment

3) RSO Approval

Completely filled, duly signed and stamped application form (AERB/RSD/MDX-RSO) o Copy of certificates of qualifications (Refer Prescribed qualifications for personnel in DR

practice)

o Availability of Personnel monitoring badge (TLD) for which he/she is nominated to

become RSO.

4) Personnel Monitoring Service providers

It is the responsibility of the employer to provide personnel radiation monitoring devices (TLD

badges) to the radiation workers (persons associated with the use of x-ray equipment).

The accredited personnel radiation monitoring service providers:

Sr.

No.

Name of Accredited Laboratory States Covered Telephone

1 M/s. Avanttec Lab. Private Limited,# 76, 7th

street, ground floor,Porur Garden,Phase-1,

Chennai - 600095, Tamil Nadu

Andhra Pradesh, Tamil Nadu,

karnataka, Kerala, Puducherry

(Southern Region)

044-26345288,044-

26630553/54/56

email:

[email protected]

2 M/s. Renentech Lab. Private Limited,C-106,

Synthofine Industrial Estate, Off Aarey Road,

Goregaon(E),Mumbai- 490063. Maharashtra

Maharashtra, Gujarat,

Rajasthan, Goa, (Western

Region)

022-40037476

3 M/s. Ultratech Lab. Private limited,Cloth

Market, G.E. Road, kumhari, Bhilai, Durg -

490042, Chhattisgarh.

All other states in the Central,

Northern and North Eastern

parts of the country

788-3295166,

09981212431

4 Defence Laboratory, Jodhpur All Defence institutions of the

country

GOVERNMENT OF INDIA

ATOMIC ENERGY REGULATORY BOARD


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http://www.aerb.gov.in/T/XRay/forms/Registration-X-ray.doc

http://www.aerb.gov.in/T/XRay/forms/layout_guidelines.pdf

http://www.aerb.gov.in/T/XRay/forms/License-CT-Cath.doc



http://www.aerb.gov.in/T/XRay/forms/RSO%20approval.doc

5) Points to be noted

a) No two X-ray equipment should be installed in the same room

b) X-ray installations should be located as far as feasible from areas of high occupancy such as

maternity, pediatric and ultra sonography rooms and other departments not directly related to

radiation applications in medicine.

c) Periodic safety status reports as per prescribed format on AERB website should be maintained by

registrant/ licensee.

d) Quality Assurance should be conducted once in two years on every x-ray equipment and records

to be maintained by registrant/licensee.

e) Other requirements relevant to medical diagnostic installations are prescribed in AERB safety

Code (AERB/SC/Med-2), 2001 and its amendment.

6) Renewal of Registration/ License: Application for renewal of Registration/ Licence shall be

submitted to Head, RSD, AERB at least 3 months prior to their validity date.

TABLE –A: Requirements for Registration to use/ operate X-ray equipment .

(Ref. Application form AERB/RSD/MDX/REG)

Type of X-ray unit Requirements for layout

of the room to install

X-ray equipment

Requirements for Registration

Radiography/

Fluoroscopy/

Mammography/

OPG/

Dental CBCT

Kindly see layout and

shielding guidelines for

diagnostic x-ray

installations (as applicable)

2 copies of layout of X-ray equipment room (in

1:50 scale)

Copy of valid NOC/ Type Approval certificate of

X-ray equipment

Copy of RSO approval, if already obtained

Availability of protective accessories ( Mobile

protective barrier, protective apron of 0.25mm Pb

equivalent)

List of qualified/ trained personnel with TLD

badges numbers (which should include names of

doctors, operator and RSO )

Copy of authenticated QA report

C-arm/

Mobile

radiography/ Intra

oral dental

equipment/

BMD

Not applicable Copy of valid NOC/ Type Approval certificate of

X-ray equipment


Availability of protective accessories ( Mobile

protective barrier, protective apron of 0.25mm Pb

equivalent)

List of qualified/ trained personnel with TLD

badges numbers (which should include names of

doctors, operator and RSO)



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http://www.aerb.gov.in/T/XRay/forms/Registration-X-ray.doc




TABLE –B: Requirements for License to use/ operate CT/ IR equipment

(Ref Application form AERB/RSD/MDX/LIC)

Type of X-ray

equipment

Requirements for

Layout Approval of

CT/IR room

Application form:

Requirements for Licence

Computed

Tomography/

Interventional

Radiology (Cath-

Lab)

Kindly see layout and

shielding guidelines

for diagnostic x-ray

installations (as

applicable)

2 copies of layout of X-ray equipment room (in 1:50 scale)

Copy of valid NOC/ Type Approval certificate of X-ray

equipment


Availability of protective accessories ( Mobile protective barrier,

protective apron of 0.25mm Pb equivalent)

List of qualified/ trained personnel with TLD badges numbers

(which should include names of doctors, operator and RSO )


Copy of Radiation Protection Manual.


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Guidelines for shielding of x-ray installations

The utility can hence forth follow the standard layout plans as provided in AERB web-site or customize it as per guidelines given below:

Options in shielding materials

X-ray equipment must be installed in adequately shielded rooms to ensure that public in the vicinity of

the x-ray installations are not unduly exposed to x-ray radiation. The adequacy of shielding depends on

the material and thickness used for this purpose. Different materials can be used for shielding. However,

brick or concrete are considered the best materials, as they are easily available, economical, and have

good structural strength.

While lead is a suitable shielding option for energies encountered in diagnostic x-rays, it is a weak

structural material with tendency to lose uniformity and needs periodic radiation survey to ensure its

continued adequacy. Also, Lead poses a serious environmental hazard and the use of it is being

discouraged the world over. Recently, many new materials are being used/ developed as potential

shielding materials, as an alternate to Lead. AERB would like to promote use of these materials, on

demonstration of shielding adequacy.

Step- by-step guidelines for submission of layout plan in diagnostic radiology facility 1) Decide a suitable room for housing an X-ray unit to facilitate the easy movement of staff and

patient positioning.

2) Room should have preferably one entrance door and window if present, should be above 2m from the finished floor level outside the x-ray room.

3) Door should have a hydraulic mechanism to ensure that door is closed during procedure and

should be provided with overlapping at the joints to avoid streaming.

4) Identify the walls as Wall A, Wall B, Wall C & Wall D (in any sequence)

5) Position the location of the equipment for each modality as follows:

a) Radiography and Fluoroscopy equipment: Couch, Control console and chest stand

- In such a way that chest stand is on the opposite wall of the entrance door and the control console.

- Mobile protective barrier with lead equivalent glass viewing window should be positioned in such a manner that the operator is completely shielded during the exposure.

- Control console should be positioned as far away as possible from the x-ray tube.

b) Computed Tomography and Interventional radiology equipment: Gantry / C-Arm, Couch,

Separate control console room, viewing window,

- Position the gantry and couch such that the patient is completely visible from the control console, during the scanning

- The entrance door to the gantry room from the control console shall have similar requirements as the patient entrance door.

c) Mammography/ OPG/ CBCT: Control console, Equipment and Protective barrier

Positioning of equipment should be as far as possible from the door and the control console.


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6) Decide on the material and thickness of walls and door by referring to equipment specific table.

7) Measure the distances of all the walls, doors, windows from the centre of the couch

8) Tabulate the details of layout and shielding as given in Annexure-1

9) Note that the required shielding of any material shall be provided at least up to the height of 2m from

external finished floor of x-ray room.

PLEASE NOTE:

The final assessment of the adequacy of the design and construction of structural shielding is based on the radiation

survey of the completed installation to be carried out at the time of commissioning after installation by supplier of the

equipment. If the assessment survey shows deficiencies, additional shielding or modification of equipment and

procedures are required.

REFERENCE DATA ON SHIELDING OF X-RAY INSTALLATION ROOM

Radiography and Fluoroscopy

Shielding Material

Distance from centre of patient Table

1.5 m 2.0 m Primary wall of dedicated chest x-ray installation at 2 m

Brick (cm) 23 20 20

Concrete (cm) 15 12 12

Steel (cm) 2.3 2.0 2.0

Lead (cm) 0.17 0.15 0.15

**Any other material 2.0TVT 1.8 TVT 1.8 TVT

Floor (if installation is not on ground floor) and ceiling thickness of 6-8 inch concrete is adequate.

Computed Tomography

Shielding Material

Distance from iso- centre

1.5m 2.0 m 2.5 m 3.0

Brick (cm) 27 25 23 20

Concrete (cm) 18 15 13 12

Steel (cm) 2.7 2.5 2.0 1.8

Lead (cm) 0.21 0.18 0.15 0.14

**Any other material 3.0 TVT 2.8 TVT 2.6 TVT 2.5 TVT


Interventional Radiology (Cardiac Angiography)

Shielding Material


1.5 m 2.0 m 2.5 m 3.0 m

Brick (cm) 25 23 20 18

Concrete(cm) 18 15 12 11

Steel (cm) 2.5 2.0 1.5 1.3

Lead (cm) 0.2 0.18 0.16 0.15

**Any other material 2.35 TVT 2.0 TVT 1.95 TVT 1.8 TVT



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Mammography

Shielding Material


Standard gypsum wallboard construction is usually

adequate to shield the walls of mammography facility (as per thickness given below)

Solid core wooden door ( 5 cm thick) leading to corridors outside a mammography room provide adequate shielding. Standard wooden doors may not be sufficient if the shielded area has significant occupancy.

Standard concrete construction provides adequate barriers above and below mammographic facilities

Lead lined walls and doors are usually not required

1.0 m 1.5m

Gypsum Wallboard (cm) 1.5 1.0

Plate Glass (cm) 1.0 1.0

Concrete (cm) 1.0 1.0

Brick (cm) 1.5 1.0

**Any other material 2 TVT 1.68 TVT

Bone Mineral Densitometry

Dose rate at 1m is less than allowable dose limit for public hence no structural shielding is needed even with the smallest

room.

Dental CBCT/OPG (Ref: - Report of HPA working party on dental CBCT (HPA-RPD-065)

Shielding Material


0.5m* 1.0m 1.5 m 2.0m

Brick (cm) 22 17 15 12

Concrete (cm) 15 11 9.5 8

Baryte Plaster (cm) 1.5 1.0 -- --

Lead (cm) 0.22 0.17 0.15 0.12

**Any other material 2.6 TVT 2 TVT 1.72 TVT 1.4TVT

*Considered at this distance as the foot print of this equipment is small 100cm X 150cm Floor (if installation is not on ground floor) and ceiling thickness of 6-8 inch concrete is adequate.

Dental -intra oral radiography (Recommendatory)

Shielding Material


1.0m 2 m 4.0m

Primary wall

Secondary wall

Primary wall

Secondary wall

Primary wall

Secondary wall

Brick (cm) 12 5 10 5 8 --

Concrete (cm) 9 4 7 2 5.0 --

Lead (cm) 0.1 0.04 0.08 0.02 0.06 --

C- Arm and Lithotripsy x-ray equipment:

Mobile C-arm and Lithotripsy equipment should be used in Operation Theater with normal wall thickness of 9” brick/ 6”

concrete and should have 1.0 mm lead lined doors/windows.

**Note: : Lead free shielding materials have been developed by Council of Scientific and Industrial Research (CSIR)- Advanced

Materials & Process Research Institute (AMPRI), Bhopal. These materials may also be used as biological shielding material for

construction of medical diagnostic x-ray installations (X-ray room). For further details of these materials you may visit the website

www.ampri.res.in.


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FORMAT FOR SUBMISSION OF LAYOUT DETAILS OF MEDICAL X-RAY INSTALLATION

Type of equipment: Model name:

Wall Identification Distance from exposure

area (from centre of the couch)

Material used for shielding Thickness of the shielding material (cm)

Wall A

Wall B

Wall C

Wall D

Entrance Door

Any other door

Window, if any, if at the height less than 2 m from outside finished floor of x-ray room

Floor

Ceiling

Check list to be filled by applicant Status

1 All the walls are identified and distances of walls from the centre of the couch/equipment are indicated in the layout drawing

2 Layout drawing indicates the location of the mobile protective barrier

3 Layout drawing indicates x-ray machine, couch, control panel/ control room, chest stand, windows, doors, make and model of the x-ray equipment.

4 Layout drawing is signed and stamped by the applicant.

5 Layout drawing is authenticated by supplier.

6 The layout drawing is as per values filled in the above table.

7 Chest Stand is on the opposite wall of control console and entrance door Yes/ No

8 If NO whether, a permanent protective barrier is placed between operator and chest stand

9 Height of the window from outside finished floor of x-ray room is > 2 m Yes/ No

10 If No, whether shielding is provided on the window up to 2m Yes/ No

11 No permanent occupancy behind chest stand is ensured Yes/ No

Attach drawing authenticated by supplier in A4 size sheet (scale 1:50) indicating details given above.

Verified by: Name:

Signature of applicant

Signature of the supplier

Name Designation Company


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of 26

October 16, 2014 Always visit eLORA for recent guidelines

Guidelines for Applying for Licence of Diagnostic Radiology X-ray Equipments through eLORA System

General Guidelines (Applicable for all types of equipments viz. existing as well as new) ........................... 2

1. Register Your Institute ...................................................................................................................... 2

2. Prerequisites for Licence .................................................................................................................. 4

A. Declare Employees ....................................................................................................................... 4

B. Obtain RSO Approval .................................................................................................................... 6

C. Add Instrument ............................................................................................................................. 9

D. Prepare Layout ...........................................................................................................................10

E. Quality Assurance .......................................................................................................................11

Guidelines for Obtaining Licence for Existing X-ray Equipment .................................................................11

3. Declare Your X-ray Equipments ......................................................................................................11

4. Record Licence Detail .....................................................................................................................12

5. Fill Application Form for Licence ....................................................................................................13

Guidelines for Obtaining Licence for New X-ray Equipment ......................................................................18

6. Procurement of X-ray Equipment ...................................................................................................18

7. Application for Licence ...................................................................................................................18

Guidelines for Other Processes ..................................................................................................................19

8. Change in Layout: ...........................................................................................................................19

9. Safety Status Report .......................................................................................................................20

10. QA Test Summary .......................................................................................................................20

11. Radiation Survey Report .............................................................................................................20

12. Procurement of X-ray Tube ........................................................................................................20

13. Intimation of Receipt ..................................................................................................................20

14. Intimation of Decommissioning .................................................................................................21

Important Message ....................................................................................................................................21

15. NO LICENSE FEE /PROCESSING FEE BY AERB ..............................................................................21

Annexures ...................................................................................................................................................22

Annexure - 1: List of Personnel Monitoring Service (PMS) Providers ....................................................22

Annexure - 2: Standard Layouts .............................................................................................................23

a) Standard Layout of X-ray Installation .....................................................................................23

b) Standard Layout of CT Installation .........................................................................................24

c) Standard Layout of Interventional Radiology Installation ......................................................25

d) Standard Layout of Mammography Installation .....................................................................26


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General Guidelines (Applicable for all types of equipments viz. existing

as well as new)

It is mandatory for all users of medical diagnostic x-ray equipments to obtain Licence for Operation

from AERB as per Atomic Energy (Radiation Protection) Rules 2004.

To facilitate online submission of applications for regulatory consents and establish channel of

communication with AERB for other regulatory requirements, AERB has launched Diagnostic Radiology

module in its e-governance application e-LORA (e-Licensing of Radiation Applications) System. All

diagnostic x-ray equipment user Institutes are required to use eLORA for obtaining operating Licence

from AERB.

1. Register Your Institute

Visit our website www.aerb.gov.in . Click on the button eLORA, which is available on website home

page. It will redirect you to the following screen of eLORA home page.

Click on Register Institute (see above figure). This will open application form for Institute Registration.

Important Note: Guidelines to fill application form for Institute Registration is available on eLORA home page. It is advised to read the guidelines and keep soft copy of required attachments ready before start filling of application form.

Fill the application form as per the guidelines. Important points in each tab are mentioned below:

Tab 1: Institute Details


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In Type of Facility section, for the field Practice select Diagnostic Radiology and for the field Role of

Institute click on Medical Diagnostic X-ray Facility

Tab 2: Employer Details

Name: Fill the complete name of employer as appearing in his/her document for Proof of Identity/Date

of Birth (DOB) to be attached.

Date of Birth: Fill the DOB as appearing in the proof of identity/DOB to be attached

Document/card for proof of identity and date of birth (of employer): Select one from the drop down.

(Soft copy of this is a mandatory attachment).

Document/Card No. (of Proof of Identity/DOB): Must match with the proof of identity/DOB attached

E-mail (O): Will be used to send USERNAME and PASSWORD of your eLORA account and for all future

communications. (Make sure to provide correct email address).

Tab 3: Attachments

Upload of following attachments are mandatory:

Proof of Identity and Date of Birth (of employer): Acceptable documents are as follows:

o Passport

o PAN card issued by Income Tax Department

o Driving Licence issued by RTO

o Photo identity document/card having serial number and date of birth issued by

Central/State Government or PSU

Proof of Employership: Example: (i) Appointment Letter of Employer, (ii) Board Resolution, (iii)

Any Govt./PUC document substantiating proprietorship (iv) Partnership deed (notorised) or (iv)

Proprietor’s self declaration on institute letter head affixed with institute seal

Upload scan copy of any one of the document (in the relevant position) for the proof of

existence of institute:

o PAN of Institute

o TAN of Institute

o Registration with State/Central/Local Government Authority

Enter the Captch and submit the application form.

Important Note: Fields marked with * in the application form are mandatory. Application form will not be submitted if any mandatory field left blank.


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You will get acknowledgement message upon successful submission of application form. The copy of

submitted application (.pdf file) can be downloaded for which link will be provided (pl. note, this link

will be active for a shot period). You will also receive an acknowledge mail with the copy of your

application form (.pdf file) in your email (email address as provided in the application form).

2. Prerequisites for Licence

Prior to apply for Licence; follow following steps:

A. Declare Employees

For every X-ray equipment/installation, having at least one Operator and one Medical

Practitioner is mandatory for obtaining Operational Licence.

For CT and Interventional Radiology equipments, in addition to Operator and Medical

Practitioner, having RSO (Radiological Safety Officer) is mandatory for obtaining Operational

Licence.

The minimum qualification requirement for employees in Diagnostic Radiology is as given below:

Role of Employee Eligibility

Medical Practitioner M.B.B.S. /MD/MS/ BDS/MDS

Operator Qualified X-ray technologist OR Medical Practitioner (as above)

RSO Any person having valid AERB RSO approval for your Institute. In case, no person is having valid AERB RSO approval for your Institute then any Medical Practitioner (as above) OR Qualified X-ray technologist (with three years experience in the field of CT/Interventional Radiology) can be nominated for RSO approval after registering as Radiation Professional (RP) in e-LORA.

Complete guideline and application form for RP registration is available in e-LORA home page.

A person need to submit RP registration form for Practice: ‘Diagnostic Radiology’ and Professional Role: ‘Radiation Safety Professional’.

After acceptance of your application form, you will get USERNAME and PASSWORD of your eLORA

account in your email. Visit to eLORA home page to login to the system.

For adding employees to your institution, please follow the path as:

Menu User management Add Employee Select required Type of Employee from drop down

In drop down for Type of Employee, three options available as follows:

Radiation Worker (this is to add employee with role Operator and Medical Practitioner)


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Non Radiation Worker (this is to add Licensee who may not be a radiation worker)

Radiation Professional (this is to add Radiation Professional who is to be nominated as RSO)

You are required to add Operator and Medical practitioner in the type Radiation Worker.

In the form for adding Radiation Worker,

Provide required personal information of employee viz. Title, Name, Gender and Date of Birth

Provide required service information of employee viz. Date of Joining (of service in your

institute), PMS No. (i.e. complete TLD No.), Department, Designation, Profile (select ‘Medical

diagnostic x-ray facility’) , Role (select any one or both using Ctrl key – as applicable) and

Education Qualification (select value from drop down)

Provide address and contact detail of employee

Browse and upload scan copy of joining /confirmation letter of employee and click on Submit

Repeat the above procedure to add your other Operators and Medical practitioners.

Important Note: You will not be able to fill application form for Licence (and will get following error

message) unless you declare Operator and Medical Practitioner of your Institute.


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In case your institute is not having valid RSO, you need to obtain RSO approval from AERB. For a person

required to be nominated as RSO, you need to add him/her in the type Radiation Professional (RP).

While adding RP, system will ask RP registration ID and Date of birth of RP. (Obtain these details from

the Radiation Professional)

In the form for adding Radiation Professional,

Enter Registration ID and Date of birth of RP – personal detail of RP will come automatically.

Provide Date of Joining (of service in your institute), PMS No. (i.e. complete TLD No.),

Department and Designation, Profile (i.e. ‘Medical diagnostic x-ray facility’) and Role (i.e.

‘Operator’, Medical Practitioner’ or both)

Provide Email (O)

Browse and upload scan copy of joining /confirmation letter of employee and click on Submit

Important Note: Radiation Professional can subsequently be nominated for the approval of Radiological Safety Officer (RSO). Process of RSO nomination explained in Sr. No.: B

B. Obtain RSO Approval

In case you do not have valid RSO for your CT and Interventional Radiology facility, obtain RSO approval.

For CT and Interventional Radiology facilities, RSO approval is mandatory. For nominating your

employee for RSO approval, follow the path as:

Menu Regulatory Forms Common Forms


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Select the name of employee in Radiation Professional

Fill the asked information and click on Freeze. This will freeze your application form and show your

application number. Please note, Freeze does not mean submission of application form to AERB.

For submission of RSO nomination application form, follow the path as:

Menu My applications

Select required Application No. (Application Status is shown as Pending For Signed PDF). Click on Show

Details and download PDF of your application form from Download Link. Take a print of first page,

Employer and Nominated RSO shall duly sign the first page (their names will appear in the form, sign

above the respective names) and affix institute seal on it. Scan this page (in .pdf format), Browse and

upload this scan copy.


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After uploading of scan file, Application Status will change to Signed PDF Uploaded

Select the Application No and click on Submit to complete submission of application form (Application

Status will change to Submitted).

Important Note: The above mentioned procedure of submission of application is applicable for other


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regulatory forms where signature of two persons required.

Your RSO nomination form will be reviewed by AERB and after acceptance; you will get its notification

in your eLORA account.

C. Add Instrument

Diagnostic X-ray facility must have certain types of instruments (list is given in Table 1: List of

Instruments Required) and the same must be declared in eLORA.

To declare instruments, follow the path as:

Menu Instrument Management Add Instrument

In drop down for Type of Instrument, four options available as follows:

Measuring Tool (not applicable for you)

Monitoring Tool (not applicable for you)

QA Tool (not applicable for you)

Safety Tool

Add following Instruments as applicable to each type of equipment:

Table 1: List of Instruments Required

Type of Equipment Instruments to be added

Type of Instrument Instrument Sub Type

Interventional Radiology

Safety Tool Protective Apron (minimum 3)

Protective Rubber Flaps

Ceiling suspended protective glass Computed Tomography Safety Tool Protective Apron

Radiography & Fluoroscopy

Safety Tool Mobile Protective Barrier with Viewing Window

Protective Apron

Protective Rubber Flaps

Radiography(fixed) Safety Tool Mobile Protective Barrier with Viewing Window

Protective Apron

Mammography OPG CBCT

Safety Tool Mobile Protective Barrier with Viewing Window


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Radiography (Mobile) Radiography (Portable) C-arm/O-Arm Dental (Intra-oral) Dental (Hand –held)

Safety Tool Protective Apron

Provide the required information while adding equipment.

Important Note: You will not be able to fill application form for Licence (and will get following error

message) unless you declare required Instrument(s).

D. Prepare Layout

Prepare a sketch of layout (1:50 scale) of each x-ray room (not applicable for Radiography (mobile), C-

Arm, O-Arm, Dental (Intra-oral) and Dental (Hand –held) X-ray equipment) providing all the details

about wall dimensions, wall thickness, wall/shielding material, distances of all walls/shielding from x-ray

equipment, relative positions of x-ray equipment, couch, control console/control room, protective

barrier, door(s), window(s) , occupancy around the x-ray room etc. For the preparation layout details,

guidelines and model layout plans are available on AERB website

(http://www.aerb.gov.in/AERBPortal/pages/English/X-Ray/X-Ray_jsp.action) as well as enclosed here as

Annexure - 2: Standard Layouts.

You are required to preserve the duly signed and stamped copy of x-ray room with details of shielding

at your institution and same will be verified during AERB inspection.

There is no requirement to prepare a new layout plan in case you already have AERB approved layout

plan. The same can be used as a record for layout.

If your x-ray room is as per model layout or has AERB approved layout, you need not to submit all

details in the application form for License.

In case your x-ray room does not follow standard requirements,

You will be required to provide the details in the prescribed format in the application form for

operating Licence, as well as

You will have to get radiation survey done from supplier of equipment or authorized agencies as

per prescribed format as given in application form for operating Licence.

Important Note: While submitting Operational Licence application form for CT and Interventional Radiology equipment, you will be asked to upload scan copy of duly signed and stamped layout plan.


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E. Quality Assurance

Prior to apply for licence for operation of existing x-ray equipment, conduct its Quality Assurance (QA)

as per AERB prescribed format. The Quality Assurance (QA) formats are available on AERB website

(http://www.aerb.gov.in/AERBPortal/pages/English/X-Ray/XRAYmanfform_jsp.action).

Important Note: While submitting Operational Licence application form for CT and Interventional Radiology equipment, you will be asked to upload scan copy of duly signed and stamped QA.

Guidelines for Obtaining Licence for Existing X -ray Equipment

3. Declare Your X-ray Equipments

After login, you will see following screen with various Menu on left hand side. You will have to declare

your all X-ray equipments one-by-one. Click on Declare Existing X-ray Equipment to declare your

existing x-ray equipment.

Provide the detail as asked in the form and click on Submit.

After successful submission, an acknowledgement message with equipment id will be displayed.


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You will receive a system generated mail in your registered email id with acknowledgement letter as an

attachment. Acknowledgement letter can also be downloaded from menu My Applications.

Repeat the same procedure to declare your all X-ray equipment.

4. Record Licence Detail

In case the declared X-ray equipment of your Institute is having valid licence (issued by AERB) for

operation, select ‘Yes’ in the below screen. Form for recording licence details will be opened.

Otherwise, the form for recording licence detail can be accessed by clicking on menu Record Licence for

Operation of X-ray Equipment (as shown below)

This will open form as shown below:


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Provide following required details and submit the form:

Equipment Id: To be selected from provided List (all your declared equipments will appear

here)

Reference number of licence for operation: as appearing on AERB licence/registration

Issuance date: as appearing on AERB licence/registration

Expiry date: as appearing on AERB licence/registration

Upload copy of Licence for operation: Browse and upload scanned copy of AERB

licence/registration

After successful submission, following message will be displayed. The submitted application form (.pdf

file) can be downloaded from the link provided therein.

Your Licence record detail will be verified by AERB. After acceptance of your submitted detail, you will

receive a system generated message in your registered email address with an acknowledgement letter

as an attachment. An acknowledgement letter can also be downloaded from menu My Applications.

5. Fill Application Form for Licence

The application form for licence is available in menu.

Menu Licence for Operation of Existing Equipments

Important Note: You won’t be able to fill the application form if required prerequisites are not completed.


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A form will be opened as shown below:

Form initially will have three tabs:

1. Employee Detail: This will show the list of employees added as Radiation Professional.

(Employees added as Radiation Worker and Non Radiation Worker will not be show).

2. Safety Tools Detail: This will show the list of Instruments added.

3. General Detail: In the field Application for, select Licence for Operation for first time

application. In future, select Renewal of Licence for Operation for submission of form for

renewal of existing Licence. Then click on Equipment Id, it will show list of equipments

declared by you. Select Equipment for which you wish to submit application form.


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Provide Serial Number of Equipment if available.

In case you have approved RSO (RSO approval received on paper), select Yes and provide required

detail and upload scan copy of RSO approval letter.

In case you do not have approved RSO, then select No and select one of your employee in the field

Name of the person designated as RSO for this equipment (this will not be applicable for CT and

Interventional Radiology equipment).

Important Note: Obtain prior approval of RSO for CT and Interventional Radiology equipment if you do not have valid RSO.

After selection of equipment, two more tabs will be displayed (viz. Layout Detail and QA Test Report)

4. Layout Detail: If installation layout of your equipment is as per AERB model layout, then select

Yes


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Important Note: While submitting Operational Licence application form for CT and Interventional Radiology equipment, you will be asked to upload scan copy of duly signed and stamped layout plan.

If X-ray equipment installation layout is not as per AERB model layout, then select No.

Provide the detail as per your room layout plan (as explained above in section D: Prepare

Layout)

upload copy of room layout plan (in case of CT and Interventional Radiology)

For Radiation Survey Report: Get radiation survey done from supplier of equipment or authorized

agencies as per prescribed format and provide the details in the application form (as applicable):

The exposure parameters to be selected for while carrying out survey are given in the table:

Type of Equipment Applied Voltage # Applied Current *Exposure time


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(kV)

(mA) (Sec)

Interventional Radiology Radiography & Fluoroscopy Radiography(fixed)

80-100 50 – 100 1.0 -2.0

OPG CBCT

60-100 8-20 1.0 -2.0

Computed Tomography 110-140 50 - 100 1.0 – 2.0

Mammography 30-35 100-200 1.0 – 2.0

* Exposure time should not be less than 1 Sec

Work load: work load can be calculated as per the formula given below:

Workload (mAmin/Wk) = No. of patients/Wk x No. of f i lms/pat ient x mAs/fi lm x 1/60

Provide the values of maximum radiation level (in mR/hr) at following places:

Near control console (operators position)

Outside patient entrance door

Behind chest stand wall

Behind window (if any)

Patient waiting area

5. QA Test Report: Refer QA test report of x-ray equipment and provide required test results.

Attach the copy of QA test report in the prescribed format (applicable for CT and

Interventional Radiology equipment).

For submission of your application form, read and select the terms and condition and click for Submit.

After successful submission you will receive the acknowledgement in your inbox and registered email.

Repeat the same procedure for submission of Licence application form for your other equipments.


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Guidelines for Obtaining Licence for New X-ray Equipment

6. Procurement of X-ray Equipment

After fulfilling the general requirements, follow following path to open Procurement form for new

equipment:

Regulatory Forms Medical Diagnostic Radiology Procurement of X-ray Equipment

Fill the information asked in the form and upload mandatory attachments. Your application will be

reviewed by AERB. After approval/rejection, you will get notification in your eLORA account. You can

view your complete application along with AERB letter in ‘My Applications’.

Important Note: After supply of equipment, your supplier has to submit installation report on behalf of your institute. After acceptance of installation report by AERB, you need to submit application for Licence. (You will get notification of installation report acceptance in your eLORA account as well as in your email).

7. Application for Licence

After approval of installation report of your X-ray equipment by AERB, fill the application form for

Licence. Licence form has to be submitted within 6 months from the date of acceptance of installation

report. In case Licence form is not submitted within 6 month, you have to submit fresh QA report

before applying for Licence.

Ensure that required Employee and Instrument details are provided in your account. Follow following

path to access Licence form:

Regulatory Forms Medical Diagnostic RadiologyLicence for Operation


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Select the equipment id, agree terms and conditions and press submit button for submission of your application form.

Guidelines for Other Processes

8. Change in Layout:

In case of change in layout (due to Layout modification of installation, relocation and reposition of

equipment from its original place), you need to fill form for Change in Layout. Follow following path to

access this form:

Regulatory Forms Medical Diagnostic RadiologyChange in Layout


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Pl. note, in this form you will have to provide detail of shielding around X-ray equipment as asked in

Licence form. Fill the detail as required in the form and submit.

9. Safety Status Report

Use this form to submit safety annual safety status of your Institute. Follow following path to access this

form:

Regulatory Forms Medical Diagnostic RadiologySafety Status Report (Patient Examination Report

/Operation Safety Report)

10. QA Test Summary

Use this form to submit QA test summary of periodic QA or QA done after layout change. Follow

following path to access this form:

Regulatory Forms Medical Diagnostic RadiologyQA Test Summary

11. Radiation Survey Report

In case of change in layout, you need to submit radiation survey around the installation. The same form

is also be used to submit Periodic RSR (RSR – Radiation Survey Report). Follow following path to access

this form:

Regulatory Forms Medical Diagnostic Radiology Radiation Survey Report

12. Procurement of X-ray Tube

This form is used to apply for procurement of X-ray tube (in case of replacement of old/damaged x-ray

tube). Follow following path to access this form:

Regulatory Forms Medical Diagnostic RadiologyProcurement of X-ray Tube

13. Intimation of Receipt

After receipt of new X-ray tube, you need to intimate its receipt through Intimation of Receipt form.

Follow following path to access this form:


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Regulatory Forms Medical Diagnostic RadiologyIntimation of Receipt

14. Intimation of Decommissioning

In order to intimate decommissioning of your X-ray equipment, use this form. Follow following path to

access this form:

Regulatory Forms Medical Diagnostic RadiologyIntimation of Decommissioning

Important Message

15. NO LICENSE FEE /PROCESSING FEE BY AERB

It may please be noted that AERB does not charge any fee for issuance of regulatory consents including

license or registration. However, It has been brought to the notice that some of the suppliers/agencies,

while providing services/assistance to the users of Diagnostic X-ray facility for getting their X-ray

equipment licensed or registered by AERB, are demanding money to be paid to AERB. In case anybody

demands for payment to be made to AERB or any of its officials, kindly provide all the details to:

The Vigilance Officer

Atomic Energy Regulatory Board

Niyamak Bhavan, Anushaktinagar

Mumbai – 400094

Telefax: 022-25576255

e-mail: [email protected]


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Annexures

Annexure - 1: List of Personnel Monitoring Service (PMS) Providers

The following Accredited Laboratories provide TLD services in the respective states as mentioned

below:

Sr. No. State Name of Accredited Laboratory

1. Andhra Pradesh, Tamil Nadu,

Karnataka, Kerala, Puducherry,

Andaman and Nicobar and

Lakshdeep (Southern Region)

Avanttec Lab. Private Limited

31, Kamraj Street, Srinivasa Nagar, Padi, Chennai,

Tamil Nadu

Pin- 600050

Tel.: 044-26345288, 044-26630553/54/56

2. Maharashtra, Gujarat, Rajasthan,

Goa, Dadra and Nagar Haveli and

Diu (Western Region)

Renentech Lab. Private Limited

C-106, Synthofine Industrial Estate, Off Aarey Road,

Goregaon (E), Mumbai, Maharashtra

Pin- 490063

Tel.: 022-40037476

3. All other states in the Central,

Northern and North Eastern parts of

the country

Ultratech Lab. Private limited

Cloth Market, G.E. Road, kumhari, Bhilai, Durg,

Chhattisgarh

Pin- 490042

Tel.: 0788-3295166, 09981212431

4. All Defence institutions of country Defence Laboratory, Jodhpur


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Annexure - 2: Standard Layouts

a) Standard Layout of X-ray Installation

Legend: 1. Examination Table 2. Spot Film Device 3. Column Stand 4. X-ray Tube Head 7. Chest Stand 8. Control Unit 9. Mobile Protective Barrier

with lead glass viewing window of 1.7 mm lead equivalence

Name of Institute:

Complete Address of Institute:

Make of X-ray Equipment:

Model of X-ray Equipment:

Signature of Head of Institute:

[Seal of Institute]


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b) Standard Layout of CT Installation

Legend: 1. CT Gantry 2. Examination Table 3, 4. Control Unit 5. Viewing glass window of

100cm x 80cm of 2.0 mm lead equivalence

Name of Institute:





[Seal of Institute]


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c) Standard Layout of Interventional Radiology Installation

Legend: 1. C-arm 2. Examination Table 5. Fixed Radiation Shield 6,7,8. Control Unit 9. Viewing glass window of

120cm x 100cm of 2.0 mm lead equivalence

Name of Institute:





[Seal of Institute]


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d) Standard Layout of Mammography Installation

Legand: 1. Mammography Equipment 2. Control Unit with protective

barrier of 1.5 mm lead equivalence

Name of Institute:





[Seal of Institute]


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Checklist for submission of application form for Registration

*Incomplete submission may cause delay in processing of the application.

Name of the Hospital/Institution: City

State Sr.No.

Checkpoints

Status

1 Application form is completely filled, duly signed and stamped YES/NO

2 Address for correspondence is correctly mentioned with pin code (courier doesn’t reach without pin code)

YES/NO

3 Name of related medical practitioner, operator and RSO is given in the staff list YES/NO

4 TLD badge numbers of radiation workers are provided in the staff list YES/NO

5 Copy of

a) Valid Type Approval/NOC is enclosed b) For nominated RSO, latest qualification certificates are enclosed

c) QA report is enclosed

YES/NO YES/NO

YES/NO

6 Layout report and 2 copies of layout are enclosed YES/NO

7 Undertaking/declaration has been duly signed and stamped YES/NO

Place: Signature:

Date: Name of the Applicant:


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Form ID: AERB/RSD/MDX/REG

Government of India Atomic Energy Regulatory Board

Niyamak Bhavan Anushaktinagar,

Mumbai – 400 094

APPLICATION FOR REGISTRATION OF DIAGNOSTIC X-RAY EQUIPMENT [RADIOGRAPHY / RADIOGRAPHY & FLUOROSCOPY (R&F) / DENTAL/

ORTHO-PANTOMOGRAPHY (OPG) / MAMMOGRAPHY/ BONE DENSITOMETER] -----------------------------------------------------------------------------------------------------------------------------------

a) This Application would be considered by the competent authority for issuance of relevant consents, under the Atomic Energy (Radiation Protection) Rules, 2004).

b) The duly filled-in form should be sent to Head, Radiological Safety Division, (RSD) AERB, Niyamak Bhavan, Anushaktinagar, Mumbai-400094 with the necessary documents.

c) Incomplete applications and those without all relevant documents are liable to be rejected. d) All the forms pertaining to this facility can be downloaded from the website www.aerb.gov.in e) Attach extra sheets wherever required ---------------------------------------------------------------------------- -----------------------------------------------------

PART A GENERAL PARTICULARS

A.1 Name of the institution: Address of the institution (for correspondence):

Telephone No Fax No. Institution Personnel Monitoring Number:

A.2 Name of the Head of the institution $: Telephone No Mobile no Fax No. Email

A.3 Name and designation of the applicant#: Telephone No. Mobile No Fax No. Email

(Registrant is also designated as RSO) A.4 In case applicant wish to nominate another Radiological Safety Officer (RSO)*,

Name and Designation

Telephone No. Mobile No. Fax No. Email RSO Approval reference No.: Valid up to

A.5 Address of installation of the X-ray equipment: --------------------------------------------------------------------------------------------------------------------- # Applicant is the person in whose name the licence to handle the source may be issued, under AERPR-2004, and would have the responsibilities of “licencee” prescribed in AERPR-2004 and should be a full time employee of the institution $ The head of the institution is the person who would have the responsibilities of “employer” prescribed in RPR-2004 * RSO is the person who is so designated by employer and approved by competent authority and have the responsibilities of “Radiological Safety Officer”.


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PART B

DETAILS OF THE EQUIPMENT B.1: Whether the equipment is: New/ pre-owned B.2 In case of pre-owned: purchased/received from (name and address): B.3 Type of Equipment

1) Radiography fixed/ R&F combined/ Radiography ( Mobile)/ Mammography/ C-arm/ dental/BMD/ 2) others (please specify) B.4 Purpose Medical Diagnosis/ Research/ Veterinary/ others (please specify) B.5 Details of equipment (Attach extra sheets if required)

Sr. No.

Type of equipment

Model Name Supplier Name Date of installation

NOC / Type Approval No. (attach copy)

Max kVp

Max. mA/mAs

B. 6 Quality Assurance report enclosed: YES/NO

If QA report is not enclosed with this application, Quality Assurance tests on the X-Ray machines to be conducted within six months from the date of application and records to be maintained with the institution.

B. 7 Layout report is enclosed (applicable only for fixed installations): YES/NO B. 8 AVAILABILITY OF RADIATION PROTECTION ACCESSORIES

1. Red light, X-Ray Caution Symbol and Warning Placards 2. Lead aprons 3. Quality Assurance kit (optional)

B.9 WORK LOAD DETAILS

Name of Examination No. of patients/day mAs/exposure kV

Chest

Abdomen

Extremities

Skull

Spinal

Special Procedures


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PART C

STAFF DETAILS (Please attach separate list if required)

Sr.No.

Name Academic/Professional Qualification

Experience PMS (TLD Number)

Full time /Part time

Related medical practitioner

Operators RSO

designate Attach copy

UNDERTAKING BY NOMINATED RSO

I hereby undertake to fulfil Duties and Responsibilities of RSO as follows: a) I have read and understood the AERB guidelines on radiation protection. b) I shall ensure that the radiographer/s operating the x-ray equipment are trained in radiation

protection aspects and provided with adequate protective accessories while operating the equipment c) I shall ensure that suppliers of x-ray equipment will render training to the x-ray technologist/

operator on safe operation of x-ray equipment. d) I shall ensure that the QA of the equipment is carried out once in two years, or as recommended by

AERB and maintain records thereof. e) I shall ensure that the TLD badges are distributed to the radiation workers ( whoever operates the x-

ray equipment /works around the x-ray equipment/ associated with the procedure ) f) I shall ensure that proper instructions on using of TLD badges are given to the radiation workers g) I shall maintain control TLD badge at a location away from the radiation areas h) I shall ensure that the TLD badges are sent periodically for evaluation of doses and maintain the

dose records thereof. i) I shall report any excessive exposures ( above quarterly or annual limit) to AERB j) I shall ensure that proper warning x-ray symbols , are placed on the door to the room housing the

x-ray equipment k) I shall ensure that female radiation workers get alternative employment, away from radiation areas,

on declaration of pregnancy. ( for eg, Darkroom assistant, receptionist, record keeping etc) l) I shall ensure that lead aprons are properly placed on a stand provided for the purpose, when not in

use. m) I shall ensure lead aprons are checked once in a year for integrity. n) I shall prepare and maintain periodic safety status reports which will be made available to

representatives of inspecting agency. o) I shall advise the management about regulatory requirements for installation of any new x-ray

equipment/ decommissioning of old x-ray equipment p) I shall inform the AERB, in case of relinquishing the responsibilities of Radiological Safety

Officer. I have also understood the relevant provisions of the Act, Rules and Safety Code as mentioned above and radiation safety aspects. I am solely responsible for discharging the duties of Radiological Safety Officer of diagnostic radiology department as per rule 22 of AE (RP) R-2004. Place Signature of Registrant/ RSO Date Name of Registrant/ RSO


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PART D

UNDERTAKING BY HEAD OF THE INSTITUTION AND APPLICANT I/ We hereby certify that

a) Quality Assurance tests will be conducted within six months from the date of application and records will be maintained at the premises.

b) All the statement made above are correct to the best of my knowledge and belief c) No activity will be carried out for purposes other than those specified in this form; d) Site and layout shall be as per the approved plan only. e) The equipment shall be put into operation only after obtaining Registration certificate from the

Competent Authority. f) No person below age of 18 years shall be employed as radiation worker (operator and RSO) g) All provisions of the Atomic Energy (Radiation Protection) Rules, 2004 shall be strictly complied with. h) All provisions of AERB Safety Code on Medical Diagnostic X-ray Equipment and Installations,

AERB/SC/MED- 2 (Rev–1) or the revised version thereof currently in force shall be complied with i) The facility shall not be transferred/sold/ rented by me/us to another without the prior permission of the

competent authority; j) The installation / maintenance of the equipment would be done by authorized and trained persons. k) Full facilities will be accorded by me/us to any authorised representatives of the competent authority to

inspect this installations at any time; l) Medical surveillance of all persons engaged in radiation work as required by the competent authority

will be duly carried out at my/our expense m) All recommendations made from time to time by the competent authority in respect of radiation safety

will be duly implemented; n) Duly qualified and trained manpower (including radiological safety officer, shall be appointed before the

commencement of operation of the facility; o) Decommissioning/ dismantling and reuse of the site of the decommissioned facility will be done with

prior intimation to AERB. p) All necessary facilities will be provided to the RSO to discharge his duties and functions effectively. q) Atomic Energy Regulatory Board will be immediately informed in case the RSO is relieved of his duties

and his original certificate would be returned. r) Keep AERB informed about any changes in the information furnished above

In case, it is found, at any stage, that the information provided by me/us is false and/ or not authentic, then I/ we hereby accept that appropriate regulatory actions may be initiated against me/us and our institution, in accordance with the applicable Rules.

Place: Signature: Date: Name of the Applicant: Designation:

Signature: Name of Head of the Institution:

Designation:

DECLARATION BY THE AUTHORISED SUPPLIER

Our company has installed a (type of x-ray unit) x-ray equipment model ________________, which is having a valid NOC/Type Approval certificate from AERB. Its performance/ acceptance test are demonstrated to the user’s representative on……………….

Place: _____________________ Signature of the service engineer Date: _____________________ Name Designation Company

SEAL OF THE COMPANY


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PART E

LAYOUT AND SHIELDING DETAILS OF MEDICAL X-RAY INSTALLATION Name of the hospital: Type of equipment: Model name: Identification of location (Room No.):

(Refer AERB guidelines for layout and shielding of x-ray installations) Wall Identification Distance from exposure area

(from centre of the couch) Material used for shielding

Thickness of the shielding material (cm)

Wall A Wall B Wall C Wall D Entrance Door Any other door Window, if any, if at the height less than 2 m from outside finished floor of x-ray room

Floor Ceiling

Attach drawing authenticated by supplier in A4 size sheet (scale 1:50) indicating details given above.

Verified by: Name:

Signature of applicant Signature of the supplier Name Designation Company

Check list to be filled by applicant Status

1

All the walls are identified and distances of walls from the centre of the couch/equipment are indicated in the layout drawing

2 Layout drawing indicates the location of the mobile protective barrier 3 Layout drawing indicates x-ray machine, couch, control panel/ control room, chest stand, windows,

doors, make and model of the x-ray equipment. 4 Layout drawing is signed and stamped by the applicant. 5 Layout drawing is authenticated by supplier. 6 The layout drawing is as per values filled in the above table. 7 Chest Stand is on the opposite wall of control console and entrance door Yes/ No 8 If NO whether, a permanent protective barrier is placed between operator and chest stand

9 Height of the window from outside finished floor of x-ray room is > 2 m Yes/ No 10 If No, whether shielding is provided on the window up to 2m Yes/ No

11 No permanent occupancy behind chest stand is ensured Yes/ No


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National Treatment Guidelines

for Antimicrobial Use in Infectious Diseases

NATIONAL CENTRE FOR DISEASE CONTROL

Directorate General of Health Services

Ministry of Health & Family Welfare

Government of India

Version 1.0 (2016)


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CONTENTS

Chapter 1 .................................................................................................................................................................................................................. 7

Introduction ........................................................................................................................................................................................................ 7

Chapter 2. ................................................................................................................................................................................................................. 9

Syndromic Approach For Empirical Therapy Of Common Infections.......................................................................................................... 9

A. Gastrointestinal & Intra-Abdominal Infections ......................................................................................................................................... 10

B. Central Nervous System Infections ........................................................................................................................................................... 13

C. Cardiovascular Infections .......................................................................................................................................................................... 14

D. Skin & Soft Tissue Infections ................................................................................................................................................................... 15

E. Respiratory Tract Infections ...................................................................................................................................................................... 16

F. Urinary Tract Infections ............................................................................................................................................................................. 17

G. Obstetrics And Gynaecological Infections ................................................................................................................................................ 18

H. Bones And Joint Infections ....................................................................................................................................................................... 22

I. Eye Infections ............................................................................................................................................................................................ 23

J. Ear Infections ............................................................................................................................................................................................ 25

K. Infections in Burn and Plastic Surgery ...................................................................................................................................................... 26

L. Fungal Infections ...................................................................................................................................................................................... 27

M. Febrile Neutropenia .................................................................................................................................................................................. 27

N. Post-Cardiovascular Surgery Infections .................................................................................................................................................... 29

O. Pediatric Infections ................................................................................................................................................................................... 31

P. Neonatal Infections .................................................................................................................................................................................... 39

R. Post Solid Organ Transplant ...................................................................................................................................................................... 40

S. Surgical Antimicrobial Prophylaxis ........................................................................................................................................................... 41

Chapter 3 ................................................................................................................................................................................................................ 42

Treatment Of Muti-Drug Resistant Bacterial Pathogens .............................................................................................................................. 42

1. Methicillin- Resistant S. aureus (MRSA) .................................................................................................................................................. 42

2. Vancomycin Resistant Enterococcus (VRE) ........................................................................................................................................... 42

3. Extended Spectrum Βeta-Lactamases (ESBL) Producing Enterobacteriaceae. .......................................................................................... 42

4. Carbapenem- Resistant Enterobacteriaceae (CRE) .................................................................................................................................... 42

Chapter 4 ................................................................................................................................................................................................................ 44

Guidelines For Optimizing Use Of Key Antimicrobials ................................................................................................................................ 44

A. Antimicrobial Prescribing: Good Practice ................................................................................................................................................ 44

B. Reserve Antimicrobials ............................................................................................................................................................................ 45

C. Hypersensitivity ....................................................................................................................................................................................... 45

D. Alert Antimicrobials.................................................................................................................................................................................. 46

E. Alert Antibiotics And Their Indications .................................................................................................................................................... 46

Chapter 5 ................................................................................................................................................................................................................ 49

Preventive Strategies For Healthcare Associated Infections ......................................................................................................................... 49

A. Healthcare Associated Infections .............................................................................................................................................................. 49

B. Reducing the risk of Health care associated infections.............................................................................................................................. 49

Chapter 6 ................................................................................................................................................................................................................ 50

Monitoring Antimicrobial Use ......................................................................................................................................................................... 50

A. Background ............................................................................................................................................................................................... 50

B. Need For Surveillance To Track Antimicrobial Use And Resistance ....................................................................................................... 50

C. Standardized Methodology And Outcome Measures ................................................................................................................................ 50

D. Situation In Developing Countries ............................................................................................................................................................ 51

High-end Antibiotic Monitoring Sheet .......................................................................................................................................................... 52

Surgical Prophylaxis Monitoring Sheet ......................................................................................................................................................... 52

Chapter 7 ................................................................................................................................................................................................................ 53

Dosage Guide For Commonly Used Antimicrobial Agents ........................................................................................................................... 53

Chapter 8 ................................................................................................................................................................................................................ 57

Link To National Programme Current Guidelines For Treatment Of Specific Infections......................................................................... 57

Chapter 9 ................................................................................................................................................................................................................ 59

Case Definitions And Diagnosis For Common Infections .................................................................................................................................. 59

DIARRHEA ................................................................................................................................................................................................... 59

ENTERIC FEVER ......................................................................................................................................................................................... 59

SPONTANEOUS BACTERIAL PERITONITIS ........................................................................................................................................... 59

ACUTE PANCREATITIS ............................................................................................................................................................................. 59

ACUTE BACTERIAL MENINGITIS ........................................................................................................................................................... 60

BRAIN ABSCESS ......................................................................................................................................................................................... 60

INFECTIVE ENDOCARDITIS ..................................................................................................................................................................... 60

CELLULITIS ................................................................................................................................................................................................. 61

FURUNCULOSIS ......................................................................................................................................................................................... 61

URINARY TRACT INFECTIONS ............................................................................................................................................................... 61

PNEUMONIA ............................................................................................................................................................................................... 61

ABBREVIATIONS ................................................................................................................................................................................................ 63


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Chapter 1

INTRODUCTION

Infections caused by microorganisms have threatened human life since time immemorial. During the pre-antibiotic era, these

have been a major concern for the high morbidity and mortality in humans. Some of the virulent organisms with the potential

to spread infection from one infected person to another at a very rapid rate may cause worldwide pandemics, epidemics or

outbreaks. With the discovery of the first antibiotic, "the magic bullet" Penicillin in the year 1943, patients could be effectively

cured of many life-threatening infections. This gave a huge relief to the medical practitioners. Next three decades saw the

development and discovery of a wide variety of antimicrobial agents. Subsequently, the pace of discovery of newer molecules

declined from 1970 to 1987. It has reached a “discovery void” level from 1987 onwards up till now. This is the post-antibiotic

era in which the medical practitioners have to treat and manage all types of infections with equal or greater efficiency.

Spontaneous natural development of antimicrobial resistance in the microorganisms in nature is a slow process. However, the

frequent and inappropriate use of a newly discovered antimicrobial drug leads to the development of altered mechanisms in the

pathophysiology of the concerned microbes as a survival strategy. Such antibiotic selection pressure kills the susceptible

microbes and helps in selective replication of drug resistant bacteria. These resistant bacteria already existed in the population

along with the susceptible ones or susceptible bacteria acquired resistance during antimicrobial treatment. Ultimately, such

resistant bacteria multiply abundantly and entirely replace the susceptible bacterial population. This results in treatment failure

or ineffective management of such infected patients. Antimicrobial resistance has been observed and reported with practically

all the newly discovered antimicrobial molecules till date. Antimicrobial resistance makes the treatment of patients difficult,

costly and sometimes impossible.

Emergence of antimicrobial resistance in pathogens has become a matter of great public health concern. Antimicrobial

resistance is well recognised as a global threat to human health. Infections caused by antimicrobial-resistant micro-organisms

in hospitals are associated with increased morbidity, mortality and healthcare costs. Resistance has emerged even to newer and

more potent antimicrobial agents like carbapenems. Selection and spread of resistant microorganisms in the presence of

antimicrobials is facilitated by:

Irrational use of drugs

Self-medication

Misuse of drugs

Antimicrobial resistance is closely linked to inappropriate antimicrobial use. It is estimated that 50% or more of hospital

antimicrobial use is inappropriate. There is a need for increased education and awareness about antimicrobial resistance among

the public and health-care professionals. One needs to develop and improve the surveillance system for antimicrobial

resistance and infectious diseases in general, particularly through improved linkage of data. Nothing will work unless we

improve diagnostic testing to ensure more tailored interventions and respond to the opportunities afforded by advances in

genomic technologies and point of care testing.

Since ‘post antibiotic era’ is reported to be “discovery void”; antimicrobial resistance is considered to be the most serious

health threats especially for the common infections like sepsis, diarrhea, pneumonia, urinary tract infection, gonorrhea,

malaria, tuberculosis, HIV, influenza. Presently, carbapenem resistance is reported worldwide in more than 50% of strains of

Klebsiella pneumoniae causing health care associated infections like pneumonia, blood stream infections, infections in the

newborn and intensive care units. More than 50% of Escherichia coli strains causing urinary tract infections are reported

worldwide to be resistant to fluoroquinolones. Similarly, patients suffering from gonorrhea are reported to be resistant to the

last resort of antibiotics - third generation cephalosporins. High mortality (64%) was seen among patients infected with

Methicillin resistant Staphylococcus aureus (MRSA). Over all, the antimicrobial resistance is associated with higher mortality

rate, longer hospital stay, delayed recuperation and long term disability.

Similar observations on the emergence of antimicrobial resistance in gram-negative and gram-positive bacteria are reported

also from India. The resistance range varies widely depending on the type of health care setting and the geographical location,

availability of antimicrobials in hospitals and over the counter, prescribing habits of treating clinicians coming from different

streams of medicine like allopathy, homeopathy, ayurvedic or quacks. The drug resistance has been reported to develop in a

microbial population to an antibiotic molecule following its improper and irrational use. To combat the problem of ineffective

management of infections and their complications caused by drug resistant microorganisms, it is imperative to report such

problems and generate national data at all levels of healthcare settings thus leading to a better tracking and monitoring system

in the country.

The published reports in the country reveal an increasing trend of drug resistance in common diseases of public health

importance i.e. Cholera: showing high level of resistance to commonly used antimicrobials e.g. Furazolidone (60-80%),

Cotriamoxazole (60-80%) and Nalidixic Acid (80-90%), Enteric fever: Chloramphenicol, Ampicillin, Cotriamoxazole (30-

50%), Fluoroquinolones (up to 30%), Meningococcal infections: Cotriamoxazole, Ciprofloxacin and Tetracycline (50-100%),

Gonococcal infections: Penicillin (50-80%), Ciprofloxacin (20-80%). Resistance is also seen in Meningococcal infections,

malaria, leprosy, kala-azar, TB, & HIV. Recently, NDM-1 positive bacteria have also been reported. Factors responsible for

emergence of antimicrobial resistance could be widespread use and availability of practically all the antimicrobials over the

counter for human, animal and industrial consumption. There are definite policies/guidelines for appropriate use of

antimicrobials at national level in specific national health programmes (e.g. RNTCP, National AIDS Control Programme,

National Malaria Control Programme etc.). etc

For other pathogens of public health importance like enteric fever, diarrhoeal disease, respiratory infections etc., the individual

hospitals are following their own antimicrobial policies and hospital infection control guidelines.

Reliable Indian data on antimicrobial resistance (AMR)for important pathogens of public health importance is an essential pre-


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requisite for developing/modifying appropriate guidelines for use of antimicrobials. Currently, there is no accepted national

database of antimicrobial resistance in different pathogens except for those where there is a specific national health

programme. Despite many microbiology laboratories (in both public as well as private sector) performing routine antibiotic

susceptibility testing (AST) of at least bacterial pathogens, the data is neither analysed regularly nor disseminated for use by

clinicians / public health experts / programme managers. Quality control and data sharing by these laboratories are other

important issues that need attention.

Recently, Ministry of health has launched ‘National programme for AMR Containment’ in 2012-2017, and one of the key

activities initiated under the programme is AMR surveillance with a network of ten laboratories across the country. Currently,

the National programme for Containment of AMR is generating AMR data for common bacterial pathogens from various

surveillance network sites across the country. The data generated from these surveillance sites shall be useful to understand the

magnitude and trend of drug resistance and identify the emergence of resistance, and will enable to accordingly update the

treatment guidelines.

Furthermore, need for antibiotics can be reduced by spreading the knowledge of infection control measures and adopting and

implementing the hospital infection control practices, formation of active hospital infection control teams in each hospital

working round the clock and monitoring and containing the spread of infections. The importance of hand hygiene cannot be

more emphasized in helping to control the spread of infections from one patient to another. Access to clean water also helps in

the containment of waterborne diseases and outbreaks and infections. Lastly, preventing the acquisition of an infection by

vaccination for different microbial infections will also help in reducing the need for prescription of antibiotics.

Implementation of an antibiotic stewardship program - a multidisciplinary program in the country will help to find out the

lacunae and improve upon the rational use of antibiotic with appropriate interventions and strategies.

To contain the further development of antimicrobial resistance with no new drug on the horizon and bring the existing levels of

reported resistance in the country, it is imperative to have standardized national treatment guidelines for the practitioners so

that they rationally use the currently available antimicrobial agents effectively for a long duration and manage their patients

more effectively.

How to use these guidelines?

These guidelines list the recommended treatments for common infectious diseases that are based on scientific evidence,

literature review and are consistent with the already existing international guidelines and formulated with the collective

opinion of a wide group of recognised national experts. The topics covered in this document include empiric treatment choices

for different syndromes, infections of specific body sites, and in certain special settings; antimicrobial choices for multi-drug

resistant bacterial pathogens; optimizing and monitoring use of antimicrobials; preventive strategies for healthcare associated

infections, case definitions and diagnosis of common infections.

It is emphasized that antimicrobials should be prescribed only when they are necessary in treatment following a clear

diagnosis. Not all patients need antibiotics; non−drug treatment may be suitable and this has been emphasized in these

guidelines.

In all cases, the benefit of administering the medicine should be considered in relation to the risk involved. This is particularly

important during pregnancy where the risk to both mother and foetus must be considered.

The content of these treatment guidelines will undergo a process of continuous review. Comments or suggestions for

improvement are welcome.

These suggestions may be sent to: [email protected]

DISCLAIMER: This publication provides only suggestive guidelines and the opinions expressed herein reflect those of the contributors. The

protocols described herein are general and may not apply to a specific patient. They should NOT supplant clinical judgment,

factors like hemodynamics of specific patients, availability of antimicrobials and local antibiogram of healthcare setting.


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Chapter 2.

SYNDROMIC APPROACH FOR EMPIRICAL THERAPY OF COMMON INFECTIONS

Empirical or presumptive anti-infective therapy is based on a clinical diagnosis combined with evidence from the literature

and from the educated experience of the probable pathogens causing the infection. To optimize an accurate microbiological

diagnosis, clinicians should ensure that diagnostic specimens are properly obtained and promptly submitted to the

microbiology laboratory, preferably before the institution of antimicrobial therapy. All attempts should be made to establish

diagnosis of the patients based on the facilities available to the treating doctor and affordability of the patients.

Definitive therapy depends on the microbiologic diagnosis by isolation or other direct evidence of pathogen.

According to WHO, presumptive treatment is a one-time treatment given for a presumed infection in a person, or group of

people, at high risk of infection.

Presumptive treatment is prescribed typically while waiting for the culture report or in situations where the facilities for doing

these tests is not available, is difficult or not cost effective or is impractical. However in certain situations the empirical

therapy prescribed as prophylaxis also (e.g surgical prophylaxis, high prevalence, repeated risk of exposure).

The syndromic approach is based on the presence of consistent groups of symptoms and easily recognized signs caused by a

single pathogen or a mixture of pathogens.

Before starting presumptive therapy ensure the following

1. Send and follow up on standard investigations for all suspected infections for correct and accurate diagnosis and

prognosis.

2. Antibiotics SHOULD be started only after after sending appropriate cultures if facilities are available. Similary any

change in antibiotic MUST be guided by sensitivity profile.

3. Assess the factors affecting activity of antimicrobilas such as renal excretion, interactions and allergy before

prescribing antibiotics.

4. Review of antibiotic therapy MUST be done daily and the therapy escalated or deescalated accordinglyespacially

after the culture reports are available.

Empirical Therapy si justified in patients with life threatening infections, in ICU settings and while awaiting results of culture.

The timing of initial therapy should be guided by the patient’s condition and urgency of the situation. In critically ill patients

e.g. patients in septic shock or bacterial meningitis therapy should be initiated immediately after or concurrently with

collection of diagnostic specimens. In other conditions wehere patient is stable, antimicrobial therapy should be deliberately

withheld until appropriate specimens have been collected and submitted to the microbiology laboratory e.g when treating a

patient of osteomyelitis or sub-acute endocarditis. Premature usage of antimicrobial in such cases can preclude opportunity to

establish a microbiological diagnosis, which is critical in the management of these patients.

Merits and limitations of empiric vs definitive antimicrobial therapy should be very clear to the treating doctor prescribing

antimicrobials.As the laboratory results pertaining to microbiological tests do not become available for 24 to 72 hours, initial

therapy for infection is often empiric and guided by the clinical presentation. Therefore, a common approach is to use broad-

spectrum antimicrobial agents as initial empiric therapy with the intent to cover multiple possible pathogens commonly

associated with the specific clinical syndrome. However, once laboratory results of microbiology tests are available with

identification of pathogen alongwith antimicrobial susceptibility data, every attempt should be made to narrow the antibiotic

spectrum. This is a critically helpful and integral component of antimicrobial therapy because it can reduce cost and toxicity

and significantly delay the emergence of antimicrobial resistance in the community. Antimicrobial agents with a narrower

spectrum should be directed at the most likely pathogens for the duration of therapy for infections such as community-acquired

pneumonia, urinary tract infections, soft tissue infections etc. in anOPD setting because specific microbiological tests are not

routinely performed or available or affordable.

Due considerations housld be given to the bactericidal vs bacteriostatic nature of the antimicrobial agents. Bactericidal

drugs, which cause death and disruption of the bacterial cell, include drugs that primarily act on the cell wall (e.g., β-lactams),

cell membrane (e.g., daptomycin), or bacterial DNA (e.g., fluoroquinolones). Bacteriostatic agents (e.g. sulfonamides and

macrolides) inhibit bacterial replication without killing the organismact by inhibiting metabolic pathways or protein synthesis

in bacteria. However, some antimicrobials are bactericidal against certain organisms may act as bacteriostatic against others

and vice versa. Unfortunately such distinction is not significant in vivo. Bactericidal agents are preferred in the case of serious

infections to achieve rapid cure (e.g in cases of meningitis and endocarditis).

There are few conditions where combination antimicrobial therapy is contemplated. These include conditions where

synergism of antimicrobials established or cases of infection withspecific microbes, where monotherapy is not generally

recommended (e.g., treatment of endocarditis caused by Enterococcus species with a combination of penicillin and

gentamicin). It also includes critically ill patients who may require empiric therapy before microbiological etiology and/or

antimicrobial susceptibility can be determined (e.g. suspected healthcare-care associated infections with Acinetobacter

baumannii or Pseudomonas aeruginosa). Other conditions where combination therapy may be required include cases where


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there is a need to extend the antimicrobial spectrum beyond a use of a single agent is the treatment of polymicrobial infections.

Also, it may be used where treatment is initiated for pan-resistant organisms and to prevent emergence of resistance.

Host factors like age, physiological state of the patient (e.g. pregnancy and lactation), organ function (e.g. renal or hepatic

function), genetic variation (e.g. G6PD deficiency), allergy or intolerance must be kept in mid while prescribing antimicrobial

therapy. Due consideration should be give to the efficacy of an antimicrobial agent at the site of infection (e.g. first- and

second-generation cephalosporins and macrolides do not cross the blood-brain barrier and are not recommended for central

nervous system infections. Fluoroquinolones achieve high concentrations in the prostate and are preferred oral agents for the

treatment of prostatitis).

The contents of this chapter include the commonst infections encountered in healthcare practice. The first section gives

treatment guidelines for the adult patients while the second part gives same for the pediatric and neonatal infections. The table

below describes the infective syndromes, likely causative agnets and the empirical antibiotic therapy advocated aginst them.

How to use this table:

The table is divided into sections as indicated below. Each section has 5 rows. Row 1 lists the clinical condition. Row 2 lists

the most likely agents responsible for this condition, row 3 lists the first line antibiotics while row 4 lists the alternative

antibiotic. The alternate antibiotic may be prescribed in cases when the first line antibiotics cannot be used due to

hypersensitivity or patient’s clinical parameters or non-availability of first line drugs. The table is divided into following

subsections:

Presumptive therapy for adult patients suspected of infection

A.Gastrointestinal & Intra-Abdominal Infections

B. Central Nervous System Infections

C. Cardiovascular Infections

D. Skin & Soft Tissue Infections

E. Respiratory Tract Infections

F. Urinary Tract Infections

G. Obstetrics And Gynaecological Infections

H. Bones And Joint Infections

I. Eye Infections

J. Ear Infections

K .Infections in Burn and Plastic Surgery

L. Fungal Infections

M. Febrile Neutropenia

N. Post-Cardiovascular Surgery Infections

O. Pediatric Infections

P. Neonatal Infections

R. Post Solid Organ Transplant

S. Surgical Antimicrobial Prophylaxis

A. GASTROINTESTINAL & INTRA-ABDOMINAL INFECTIONS

Condition Likely Causative

Organisms

Empiric

(presumptive)

antibiotics/First Line

Alternative

antibiotics/Second Line

Comments

Acute

Gastroenteritis

Food poisoning

Viral,

Entero-toxigenic &

Entero-pathogenic

E. coli

S. aureus,

B. cereus,

C. botulinum

None None Rehydration

(oral/IV) essential

Cholera V.cholerae Doxycycline 300mg

Oral stat

Azithromycin Oral in

children (20mg/kg)

and pregnant women

(1g)

Azithromycin 1gm Oral stat

or

Ciprofloxacin 500mg BD

for 3 days

Rehydration

(oral/IV)

is essential

Antibiotics are

adjunctive therapy.

Bacterial dysentery

Shigella sp.,

Campylobacter,

Non- typhoidal

salmonellosis

Ceftriaxone 2gm IV

OD for 5 days or oral

cefixime 10-15

mg/kg/day x 5 days

Azithromycin 1g OD x

3days

For Campylobacter

the drug of choice

is azithromycin.

Shiga toxin Antibiotic Treatment Antibiotic


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producing E. coli not recommended. use associated with

development of

hemolytic uremic

syndrome.

Amoebic dysentery

E. histolytica

Metronidazole 400mg

Oral TDS for 7-10

days

Tinidazole 2gm Oral OD

for 3 days

Add diloxanide

furoate 500 mg

TDS for 10d

Giardiasis Giardia lamblia Metronidazole 250-

500mg oral

TID x 7-10 d

Tinidazole 2 gm oral x

1 dose

Enteric fever

S.Typhi,

S.Paratyphi A

Outpatients:

Cefixime 20mg/kg/day

for 14 days or

Azithromycin 500 mg

BD for 7 days.

Inpatients: Ceftriaxone

2 g IV BDfor 2 weeks

+/-Azithromycin 500

mg BD for 7 days

Cotrimoxazole 960 mg BD

for 2 weeks

Majority of strains

arenalidixic acid

resistant.

Ceftriaxone to be

changed to oral

cefixime when

patient is afebrile to

finish total duration

of 14days.

Biliary tract infections

(cholangitis,

cholecystitis)

Enterobacteriaceae

(E.coli, Klebsiella

sp.)

Ceftriaxone 2gm IV

OD or

Piperacillin-

Tazobactam 4.5gm IV

8 hourly

or

Cefoperazoe-

Sulbactam 3gm IV

12hourly

For 7-10 days

Imipenem 500mg IV

6hourly

or

Meropenem 1gm IV

8hourly

For 7-10 days

Surgical or

endoscopic

intervention to be

considered if there

is biliary

obstruction.

High prevalence of

ESBL producing

E.coli, Klebsiella

sp.strains. De-

escalate therapy

once antibiotic

susceptibility is

known.

Hospital acquired

diarrhea

C. difficile Metronidazole 400 mg

oral TDSfor 10 days

Severe disease:start

Vancomycin 250 mg oral

6h empirically.

Spontaneous bacterial

Peritonitis

Enterobacteriaceae

(E.coli, Klebsiella

sp.)

Cefotaxime 1-2 gm IV

TDS

or

Piperacillin-

Tazobactam 4.5gm IV

8 hourly

or

Cefoperazone-

Sulbactam 3gm IV

12h

Imipenem 500 mg IV

6hourly or

Meropenem 1gm IV

8hourly

Descalate to

Ertapenem 1 gm IV

OD for 5-7 days

once the patient

improves

Secondary peritonitis,

Intra-abdominal

abscess/ GI perforation

Enterobacteriaceae

(E.coli, Klebsiella

sp.), Bacteroides

(colonic

perforation),

Anaerobes

Piperacillin-

Tazobactam 4.5gm IV

8 hourly

or

Cefoperazone-

Sulbactam 3gm IV

12hourly in severe

infections

In very sickpatients, if

required, addition of

cover for yeast

(fluconazole iv 800

mg loading dose day

1, followed by 400 mg

Imipenem 1g IV 8hourly

or

Meropenem 1gm IV

8hourly

or

Doripenem 500 mg TDS

or

Ertapenem 1 gm IV OD

Source control is

important to reduce

bacterial load.

If excellent source

control – for 5-7

days; other wise 2-

3 weeks suggested.


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2nd

day onwards) &

and for Enterococcus

(vancomycin

/teicoplanin) may be

contemplated

Pancreatitis

Mild- moderate

No antibiotics

Post necrotizing

pancreatitis: infected

pseudocyst; pancreatic

abscess

Entrobacteriaceae,

Enterococci, S.

aureus,

S. epidermidis,

anaerobes, Candida

sp.

Piperacillin-

Tazobactam 4.5 gm IV

8 hourly empirically

or

Cefoperazone-

Sulbactam 3gm IV 8

hourly in severe

infections

In very sick patients, if

required, addition of

cover for yeast

(fluconazole iv 800

mg loading dose day

1, followed by 400 mg

2nd

day onwards) &

and for Enterococcus

(vancomycin

/teicoplanin) may be

contemplated

For 7-10 days

Imipenem-Cilastatin 500mg

IV 6hourly

or

Meropenem 1gm IV

8hourly

or

Doripenem 500mg IV 8h

Duration of

treatment is based

on source control

and clinical

improvement

Diverticulitis

Mild-

OPD treatment

Gram-Negative

Bacteria

Anaerobes

Amoxycillin-

Clavulanate 625mg

TDS for 7 days

Ciprofloxacin +

Metronidazole for 7 days

Diverticulitis moderate Gram- Negative

Bacteria

Anaerobes

Ceftriaxone 2gm IV

OD +metronidazole

500 mg IV TDS or

Piperacillin-

Tazobactam 4.5 gm IV

8 hourly empirically

or

Cefoperazoe-

Sulbactam 3gm IV 8

hourly

BL-BLI agents

have very good

anaerobic cover, so

no need to add

metronidazole.

Diverticulitis

Severe

Gram- Negative

Bacteria

Anaerobes

Meropenem 1gm IV

8hrly or Imipenem

Cilastatin 500mg IV 6

hourly

Duration based on

improvement

Liver Abscess Polymicrobial

Amoxycillin-

clavulanate/ 3rd

generation

cephalosporin

+

Metronidazole 500mg

I.V.TID / 800mg oral

TID for 2 weeks

Piperacillin-Tazobactam IV Ultrasound guided

drainage indicated

inlarge abscesses,

signsof imminent

rupture andno

response to

medicaltreatment.


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B. CENTRAL NERVOUS SYSTEM INFECTIONS


Organisms

Empiric antibiotics

(presumptive antibiotics)

Alternative

antibiotics

Comments

Acute bacterial

Meningitis

S. pneumoniae,

H.influenzae,

Neisseria

meningititidis

Ceftriaxone

2 g IV 12hourly/ Cefotaxime

2 g IV 4-6hourly

10-14 days treatment

Chloramphenicol if

patient is allergic to

penicillin

Antibiotics should be

started as soon as the

possibility of bacterial

meningitis becomes

evident, ideally within

30 minutes. Do not

wait for CT scan or LP

results.

No need to add

vancomycin as primary

agent, as ceftriaxone

resistant

Pneumococcus is not

common in India.

Listeria is also rare in

India and so ampicillin

is also not indicated

Adjust therapy once

pathogen and

susceptibilities are

known.

Meningitis-Post-

neurosurgeryor

Penetratinghead

trauma

Staphylococcus

epidermidis,

Staphylococcus

aureus,

Propionibacterium

acnes, Pseudomonas

aeruginosa,

Acinetobacter

baumanii

Meropenem 2gm IV 8

hourly

AND

Vancomycin 15mg/kg IV 8

hourly

For 14 days.

May need intra

ventricular therapy in

severe cases

Meningitis with basilar

skull fractures

S.pneumoniae,

H. influenzae

Ceftriaxone 2gm IV 12

hourly

For 14 days

Dexamethasone

0.15mg/kg IV 6

hourlyfor 2-4days (1st

dose with or before

first antibiotic dose)

Brain abscess,

Subdural empyema

Streptococci,

Bacteroides,

Enterobacteria-ceae,

S.aureus

Ceftriaxone

2 gm IV 12hourly

or

Cefotaxime

2 gm IV 4-6hourly

AND

Metronidazole 1 gm IV

12hourly

Duration of treatment to be

decided by clinical &

radiological response,

minimum two months

required.

Meropenem 2gm IV

8hourly

Exclude TB, Nocardia,

Aspergillus, Mucor

If abscess <2.5cm &

patient neurologically

stable, await response

to antibiotics.

Otherwise, consider

aspiration/surgical

drainageand modify

antibiotics as per

sensitivity of

aspirated/drained

secretions.


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C. CARDIOVASCULAR INFECTIONS

Condition Likely causative

Organism

Empiric

antibiotics

(presumptive

antibiotics)

Alternative

antibiotics

Comments

Infective Endocarditis:

Native valve (awaiting

cultures) Indolent

Viridans Streptococci,

other Streptococci,

Enterococci

Penicillin G

20MU IV

divided doses, 4

hourly

or

Ampicillin 2gm

iv 4h

AND

Gentamicin

1mg/kg im or iv

8h

Duration: 4-6

weeks

Vancomycin

15mg/kg IV 12

hourly

(maximum 1g 12

hourly)//teicplani

n 12mg/kg IV 12

hourly x 3 doses

followed by 6 -

12 mg once daily

IV depending

upon severity +

Gentamicin

1mg/kg IM or IV

8 hourly

Duration: 4-6

weeks

or

Daptomycin

6mg/kg IV once

a day

Duration: 4-6

weeks

If patient is stable, ideally waitblood

cultures.

Antibiotic choice as per sensitivity

results.

Guidance from Infectious disease

specialist or clinical microbiologist is

recommended


Native valve (awaiting

cultures)

In Severe Sepsis

S.aureus

(MSSA or MRSA)

Risk for gram-

negative bacilli

Vancomycin 25-

30 mg/kg

loading followed

by 15-20 mg/kg

IV 12 hourly

(maximum 1gm

12

hourly)/teicoplan

in 12mg/kg IV

12 hourly x 3

doses followed

by 6 -12 mg once

daily IV

depending upon

severity AND

Meropenem 1gm

IV 8h

Duration: 4-6

weeks

Daptomycin

6mg/kg IV once

a day

AND

Meropenem 1gm

IV q8h

Duration: 4-6

weeks

Modify antibiotics based on culture

results and complete 4-6 weeks of

antibiotics


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Prosthetic Valve

awaiting Cultures

Vancomycin

15mg/kg IV 12

hourly

(maximum 1gm

12

hourly)/teicoplan

in 12mg/kg IV

12 hourly x 3

doses followed

by 6 -12 mg once

daily IV

depending upon

severity +

Gentamicin

1mg/kg q12h IV

Daptomycin can be used in place of Vancomycin/

Teicoplanin for

patients

unresponsive to

or intolerant of

Vancomycin/Tei

coplanin or with

Vancomycin/Gly

copeptide-

resistant isolates

Antibiotic choice as per sensitivity.

Guidance from Infectious disease

specialist or microbiologist is

recommended.

D. SKIN & SOFT TISSUE INFECTIONS


Organisms

Empiric

antibiotics

(presumptive

antibiotics)

Alternative

antibiotics

Comments

Cellulitis Streptococcus

pyogenes(common),

S.aureus

Amoxicillin-

Clavulanate

1.2gm IV

TDS/625 mg oral

TDS

or

Ceftriaxone 2gm

IV OD

Clindamycin

600-900mg IV

TDS

Treat for 5-7 days.

Furunculosis S.aureus Amoxicillin-

Clavulanate

1.2gm IV/Oral

625 TDS

or

Ceftriaxone 2gm

IV OD

Duration – 5-7

days

Clindamycin

600-900mg IV

TDS

Get pus cultures before starting

antibiotics

Necrotizing

fasciitis

Streptococcus

pyogenes, S. aureus,

anaerobes,

Enterobacteriaceae

(polymicrobial)

Piperacillin-

Tazobactam

4.5gm IV

6hourly

or Cefoperazone-

Sulbactam 3gm

IV 12hourly

AND

Clindamycin

600-900mg IV 8

hourly

Duration

depends on the

progress

Imipenem 1g

IV8hourly

or

Meropenem 1gm

IV 8hourly

AND

Clindamycin

600-900mg IV

TDS/linezolid

600 mg IV

BD/daptomycin

6mg/kg/day

Early surgical intervention crucial


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E. RESPIRATORY TRACT INFECTIONS


Organisms

Empiric

antibiotics

(presumptive

antibiotics)

Alternative

antibiotics

Comments

Community

acquired

Pneumonia

S. pneumoniae,

H.influenzae,

Legionella,

E.coli, Klebsiella sp.,

S.aureus

Mild to moderate

cases

Amoxycillin-

500mg-1 g TDS

oral.

If IV indicated,

amoxycillin-

clavulanate 1.2 g

IV TDS or

Ceftriaxone 2g IV

OD

For

Severe cases

Amoxycillin-

clavulanate 1.2 g

IV TDS

OrCeftriaxone 2g

IV OD

Duration 5-8 days

Piperacillin-

Tazobactam 4.5gm

IV 6 hourly

or

Imipenem 1g IV

6hourly

or

Cefoperazone-

Sulbactam 3gm IV

12 hourly

If MRSA is a concern, add

Linezolid 600mg IV/Oral BD

If atypical pneumonia

suspected, Doxycycline

100mg bd

or

Azithromycin 500 mg oral/IV

OD

Lung abscess,

Empyema

S. pneumoniae,

E.coli,

Klebsiella sp.,

Pseudomonas

aeruginosa,

S.aureus, anaerobes

Piperacillin-

Tazobactam 4.5gm

IV 6hourly

or

Cefoperazone-

Sulbactam 3gm IV

12 hourly

ADD Clindamycin

600-900mg IV

8hourly

3-4 weeks treatment required

Acute pharyngitis

Viral None required As most cases are viral no

antimicrobial therapy required

Group A ß-hemolytic

Streptococci

(GABHS),

Group C, G

Streptococcus,

Oral Penicillin v

500mg BD

or

Amoxicillin 500 mg

Oral TDS for 10

days

In case of penicillin

allergy:

Azithromycin

500mg OD for 5

days

or

Benzathine

penicillin 12 lac

units IM stat

Antibiotics are recommended

to reduce transmission rates

and prevention of long term

sequaelae such as rheumatic

fever

Ludwig’s angina

Vincent’s angina

Polymicrobial

(Cover oral anaerobes)

Clindamycin 600

mg IV 8 hourly

or

Amoxicillin-

Clavulanate 1.2gm

IV

Piperacillin-

Tazobactam 4.5gm

IV 6 hourly

Duration based on

improvement

Acute bacterial

rhinosinusitis

Viral,

S. pneumoniae,

H.influenzae,

M. catarrhalis

Amoxicillin-

clavulanate 1gm

oral BD for 7 days

Moxifloxacin

400mg OD for 5-

7days

Acute bronchitis Viral Antibiotics not

required

- -

Acute bacterial

exacerbation of

COPD

S. pneumoniae

H. influenzae

M. catarrhalis

Amoxicillin-

clavulanate 1gm

oral BD for 7 days

Azithromycin 500

mg oral OD × 3

days


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F. URINARY TRACT INFECTIONS

Asymptomatic bacteriuria NOT to be treated except pregnant women and immunocompromised patients. All cases of

dysuria may not be UTI. Refer to Obstetrics and gynaecology infections for treatment of asymptomatic bacteriuira in

pregnant women.


Organisms

Empiric antibiotics

(presumptive

antibiotics)

Alternative

antibiotics

Comments

Acute

uncomplicated

Cystitis

E.coli, Staphylococcus

saphrophyticus(in

sexually

activeyoungwomen),

Klebsiella pneumoniae

Nitrofurantoin 100

mg BD for 7 days

or Cotrimoxazole

960mg BD for 3-5

days

or

Ciprofloxacin 500

mg BD for 3-5 days

Cefuroxime 250

mg BD for 3-5

days

Get urine cultures before

antibiotics & modify therapy

based on sensitivities.

Acute

uncomplicated

Pyelonephritis

E.coli,

Staphylococcus

saphrophyticus (in

sexually active young

women),

Klebsiella pneumoniae,

Proteus mirabilis

Amikacin 1 g OD

IM/IV

or

Gentamicin 7

mg/kg/day OD

(Monitor renal

function closely and

rationalise according

to culture report)

Complete total

duration of 14 days

Piperacillin-

Tazobactam 4.5g

IV 6 hourly

or

Cefoperazone-

Sulbactam 3g IV

12 hourly

or

Ertapenem 1 g IV

OD

Urine culture and

susceptibilities need to be

collected before starting

antimicrobial treatment to

guide treatment.

Complicated

Pyelonephritis

Escherichia coli,

Klebsiella pneumonia,

Proteus mirabilis,

Pseudomonas

aeruginosa,

Enterococcus sp.

Frequently multi-drug

resistant organisms are

present

Piperacillin-

Tazobactam 4.5gm

IV 6 hourly

or

Amikacin 1 g OD

IV

or

Cefoperazone-

Sulbactam 3gm IV

12 hourly

Imipenem 1g IV 8

hourly

or

Meropenem 1gm

IV 8 hourly

Get urine cultures before

antibiotics & switch to a

narrow spectrum agent based

on sensitivities. Treat for 10-

14 days.

De-escalate to Ertapenem 1

gm IV OD, if

Imipenem/meropenem

initiated.

Monitor renal function if

aminoglycoside is used.

Acute prostatitis

Enterobacteriaceae

(E.coli, Klebsiella sp.)

Doxycline 100 mg

BD

or

Co-trimoxazole 960

mg BD.

In severe cases,

Piperacillin-

Tazobactam

4.5gm IV 6

hourly

or

Cefoperazone-

sulbactam 3gm IV

12 hourly

or

Ertapenem 1 gm

IV OD

or

Imipenem 1g IV 8

hourly

or

Meropenem 1gm

IV 8 hourly

Get urine and prostatic

massagecultures before

antibiotics & switch to narrow

spectrum agent based on

sensitivities and then treat

total for 3-4 weeks.

Use Ciprofloxacin (if

sensitive)


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G. OBSTETRICS AND GYNAECOLOGICAL INFECTIONS

Fluoroquinolones are contraindicated in 1st trimester.

Cotrimoxazole is contraindicated in 1st trimester.

Doxycycline is not recommended in nursing mothers. If need to administer doxycycline discontinuation of

nursing may be contemplated.

Infections

Likely organism Primary treatment

(presumptive

antibiotics)

Alternate

treatment

Remarks

Asymptomatic

Bacteriuria

> 1,00,000 cfu/ ml of

bacteria of same

species in 2 urine

cultures obtained 2-7

days apart.

Treat as per

sensitivity result for 7

days.

Nitrofurantoin 100

mg Oral, BD for 7

days

or Amoxicillin 500

mg Oral BD

x 7-10 days .

Oral

cephalosporins,

TMP-SMX or TMP

alone

Screen in 1st trimester.

Can cause pylonephritis

in upto 25% of all

pregnant women.

30 % Chance of

recurrence after

empirical therapy 1. Few

direct effects, uterine

hypo perfusion due to

maternal anemia

dehydration, may cause

fetal cerebral hypo

perfusion.

2. LBW,

prematurity,premature

labour, hypertension,

preeclampsia, maternal

anemia, and amnionitis.

Need to document

pyuria (Pus cells >

10/HPF)

Group B

streptococcal

Disease, Prophylaxis

and Treatment

Group B Streptococci IV Penicillin G 5

million units.

(Loading dose) then

2.5 -3 million units

IV QID until

delivery.

or

Ampicillin 2 gm IV

( Loading dose) then

1 gm QID until

delivery

Cefazolin 2 gm IV

(Loading Dose) and

then 1 gm TID

Clindamycin 900

mg IV TID or

vancomycin IV or

teicoplanin for

penicillin allergy

Prevalance very low so

the prophylaxis may be

required only on culture

documented report

Associated with high

risk of pre-term

labour,still birth,neonatal

sepsis

Chorioamnionitis

Group B streptococcus, Gram negative bacilli,

chlamydiae, ureaplasma and anaerobes, usually

Polymicrobial

Clindamycin/

vancomycin/

teicoplanin and

cefoperazone-

sulbactum

If patient is not in

sepsis then IV

Ampicillin

Preterm Birth, 9-11%

death rate in preterm

infant’s unfavourable

neurologic outcome,

lesser risk to term

infants.

Septic abortion

Bacteroides, Prevotella bivius,

Group B, Group A

Streptococcus,

Enterobactereaceae, C.

trachomatis, Clostridium

perfringens.

Ampicillin 500

mg QID +

Metronidazole

500mg IV TDS if

patient has not

taken any prior

antibiotic (start

antibiotic after

sending cultures)

If patient has been

Ceftriaxone 2g IV

OD


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http://emedicine.medscape.com/article/260998-overview

http://emedicine.medscape.com/article/260998-overview

19

partially treated

with antibiotics,

send blood

cultures and start

Piperacillin-

Tazobactam or

Cefoperazone-

sulbactam till the

sensitivity report

is available.

Endomyometritis

and Septic Pelvic

Vein Phlebitis

Bacteroides, Prevotella bivius,

Group B, Group A

Streptococcus,

Enterobactereaceae, C.

trachomatis, Clostridium

perfringens

Same as above.

Obstetric Sepsis

during pregnancy

Group A beta-haemolytic

Streptococcus,

E.coli, anaerobes.

If patient is in

shock and blood

culture reports are

pending, then start

Piperacillin-

Tazobactam or

Cefoperazone-

sulbactam till the

sensitivity report

is available and

modify as per the

report. If patient

has only fever,

with no features

of severe sepsis

start amoxicillin

clavulanate oral

625TDS/IV 1.2

gm TDS Or

Ceftriaxone 2gm

IV OD+

Metronidazole

500mg IV TDS

+/-gentamicin

7mg/kg/day OD if

admission needed.

MRSA cover

may be required if

suspected or

colonized

(Vancomycin/

Teicoplanin)

Obstetric Sepsis

following pregnancy

S. pyogenes,

E. coli,

S. aureus

S. pneumoniae,

Meticillin-resistant

S. aureus (MRSA),

C. septicum &

Morganella morganii.

Same as above

Sources of sepsis

outside Genital tract

Mastitis

UTI

Pneumonia

Skin and soft tissue

(IV site, surgical

site, drain site etc.)

Syphillis Refer to STD program

guidelines

Tuberculosis in

pregnancy

Similar to NON

PREGNANT

population with

Please refer RNTCP guideline

WHO has advocated that, all the first line drugs are

Very small chance of

transmission of infection

to fetus.


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some exceptions

(see comment and

chapter 8)

safe in pregnancy and can be used except

streptomycin. SM causes significant ototoxicity to

the fetus (Pyrazinamide not recommended by US

FDA)

1. Mother and baby should stay together and the

baby should continue to breastfeed.

2. Pyridoxine supplementation is recommended for

all pregnant or breastfeeding women taking

isoniazid as well as to neonate who are being breast

fed by mothers taking INH.

Late diagnosis can

predispose to LBW,

prematurity.

VIRAL INFECTIONS (NO ANTIBIOTICS TO BE GIVEN)

Influenza In

pregnancy

(seasonal And

H1N1)

The best

preventive

strategy is

administration of

single dose of

killed vaccine.

Oseltamivir 75 mg Oral

BD for 5 days

Nebulization with

Zanamvir respules (2)

5 mg each, BD

for 5 days

1. Tendency for severe

including premature labor

&delivery.

2. Treatment should

begin within 48 hrs of

onset of symptoms.

3. Higher doses

commonly used in non

pregnant population (150

mg) are not

recommended in

pregnancy due to safety

concerns.

4. Chemoprophylaxis can

be used in significant

exposures.

5. Live (nasal Vaccine) is

contraindicated in

pregnancy.

Direct fetal infection

rare

Preterm delivery and

pregnancy loss.

PARASITIC INFECTIONS

Acute

Toxoplasmosis

in pregnancy

<18 weeks gestation at diagnosis

Spiramycin 1 gm Oral qid until 16-18

weeks/Pyrimathamine + sulphadizine. Alternate every

two weeks–

Varicella

>20 wks of gestation,

presenting within 24

hours of the onset of the

rash,

Aciclovir 800mg Oral 5

times a day

IV acyclovir

recommended for the

treatment of severe

complications,

> 24 hrs from the onset

of rash, antivirals are not

found to be useful.

VZIG should be offered to susceptible women < 10

days of the exposure. VZIG has no role in treatment

once the rash appears.

The dose of VZIG is 125 units / 10kg not exceeding

625 units, IM.

Chickenpox during

pregnancy does not

justify termination

without prior prenatal

diagnosis as only.

A minority of fetuses

infected develop fetal

varicella syndrome.


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If PCR Positive -

>18 weeks gestation and documented fetal infection by

positive amniotic fluid PCR.

Pyremethamine 50 mg Oral BD x 2 days then 50 mg

OD

+

Sulphadiazine 75 mg/kg Oral x 1 dose then 50mg/kg

bd

+

Folinic Acid (10-20 mg Oral daily) for minimum of 4

weeks or for duration of pregnancy.

Malaria In

pregnancy

As per national program

GENITAL TRACT INFECTIONS

Candidiasis Candida species Fluconazole oral 150 mg single dose

For milder cases-

Intravaginal agents as creams or suppositories

clotrimazole, miconazole, nystatin.

Intravaginal azoles, single dose to 7-14 days.

Non-pregnant- If

recurrent candidiasis,

(4 or more

episodes/year) 6

months suppressive

treatment with

fluconazole 150 mg

oral once a week or

clotrimazole vaginal

suppositories 500 mg

once a week.

Bacterial

vaginosis

Polymicrobial Metronidazole500mg Oral BD x 7 days

Or metronidazole vaginal gel 1 HS x 5 days

Or Tinidazole 2 g orally ODx 3 days Or 2%

Clindamycin Vaginal cream 5 gm HS x 5 days

Treat the partner.

Trichimoniasis Trichomonas vaginalis

Metronidazole 2 gm single dose or 500 mg Oral BD X

7 days or

Tinidazole 2 gm Oral single doseFor treatment failure

– retreat with Metronidazole 500 mg Oral BD X 7

Days, if 2nd failure Metronidazole 2 gm Oral OD X 3-

5 days

Treat sexual partner

with metronidazole 2

gm single dose

Cervicitis

/Urethritis

Mucopurulent

gonoccocal

Polymicrobial

Ceftriaxone 250 mg IM Single dose + Azithromycin 1

gm single dose OR Doxycycline 100mg BD x 7 day

Pelvic

Inflammatory

Disease

(Salpingitis &

tubo-ovarian

abscess)

S. aureus,

Enterobacteriacae,

gonococci, gardenella

Outpatient treatment

Ceftriaxone 250 mg IM/IV single dose plus +/-

Metronidazole 500 mg BD x 14 days Plus Doxycycline

100 mg BD x 14 Days

Inpatient Treatment Clindamycin +ceftriaxone till

patient admitted then change to OPD treatment

Drainage of tubo-

ovarian abscess

wherever indicated

Evaluate and treat sex

partner

Mastitis

without abscess

S. aureus

Amoxycillin clavulunate/Cephalexin 500 mg QID/ OR

Ceftriaxone 2 gm OD OR

MRSA- based on sensitivities Add

Clindamycin 300 QID or

Vancomycin I gm IV 12 hourly /teicoplanin 12mg/kg

IV 12 hourly x 3 doses followed by 6 once daily IV

Mastitis with

abscess

Drainage with antibiotic cover for

MRSA

Clindamycin 300 QID or

Vancomycin 15mg/kg IV 12 hourly (maximum 1gm 12

hourly)/teicoplanin 12mg/kg IV 12 hourly x 3 doses

followed by 6 mg once daily IV


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H. BONES AND JOINT INFECTIONS


Organisms

Empiric antibiotics Alternative

antibiotics

Comments

Acute

osteomyelitis OR

Septic arthritis

S.aureus,

Streptococcus

pyogenes

Enterobacteriaceae

Ceftriaxone 2g IV OD

Followed by Oral therapy by

Cloxacillin 500mg q 8h

Or

Cephalexin 500mg q 6h

Piperacillin-

tazobactam

4.5gm IV q 6h or

Cefoperazone-

sulbactam 3gm

IV q 12h

AND

Clindamycin 600-

900mg IV TDS

Treat based on culture of

blood/synovial fluid/bone

biopsy

Orthopedic Consultation

is essential for surgical

debridement

Duration: 4-6 weeks

(From initiation or last

major debridement)

Chronic

Osteomyelitis

OR

Chronic synovitis

No empiric therapy

Definitive

treatmentguided by

bone/synovial biopsy

culture.

Treat for 6 weeks

minimum Investigate for TB,

Nocardia, fungi.

Extensive surgical

debridement.

Total duration of

treatment depends on the

joint and the organism.

Choose antibiotic based

on sensitivity.

Prosthetic joint

infection

Coagulase negative

staphylococci,

Staphylococcus

aureus,Streptococci

Gram-negative bacilli,

Enterococcus,

Anaerobes

Ceftriaxone 2g IV OD. Add

Vancomycin1gm IV BD or

Teicoplanin 800mg x 3

doses followed by 400mg

Once daily

4 weeks


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I. EYE INFECTIONS

Eyelid infections Likely organisms First line/ Suggested

Regimen

Alternate regimen Remarks

Blephritis

Unclear

S.aureus,

S.epidermidis

Lid margin care with baby

shampoo & warm compresses

24 hourly. Artificial tears if

associated with dry eye.

External Hordeolum S. aureus

Hot pack

Internal Horedeolum

Blephritis

MSSA/

S. epidermidis

Oral Cloxacillin 250-500 mg

qid or

Oral Cephalexin 500mg QID

Lid margin care with

baby shampoo & warm

compresses 24 hourly.

Artificial tears if

associated with dry eye.

MRSA

Oral Trimethoprim

sulphamethoxazole960 mg

BD or

Linezolid 600mg BD

Cunjuctival infections

Viral conjunctivitis

(pink eye)

No antibiotics required treat

for symptoms

Highly contagious.

If pain &

photophobia the

suggestive of

keratitis.

Bacterial

conjunctivitis

S.aureus,

S.pneumoniae,

H.influenzae

Ophthalmologic solution:

Gatifloxacin 0.3%,

levofloxacin 0.5%,

Moxifloxacin 0.5% 1-2 drops

q2h while awake during 1st 2

days, then q4-8h upto 7 days

Uncommon causes-

Chlamydia

trachomatis

N.gonorrhoeae

Corneal infections

Herpes Simplex

keratitis

H.simplex type

1&2

Trifluridine ophthalmic soln

1drop 2 hourly, up to

9times/day until re-epithilised.

then 1 drop 4 hourly upto 5

times/day for total duration of

21days

Ganciclovir 0.15%

ophthalmic gel for

acute herpitic keratitis.

Flurescine staining

shows topical

dendritic

figures.30-50%

recur within 2yr.

Varicella Zoster

ophthalmicus

Varicella–zoster

virus

Famciclovir 500mg BD Or

TID OR Valacyclovir 1gm

oral TID X 10days

Acyclovir 800mg 5

times/d x 10days

.

Acute bacterial

keratitis (No

comorbidities)

S.aureus,

S.pneumoniae,

S.pyogenes,

Haemophilus spp

Moxifloxacin topical(0.5%):1

drop 1 hourly for first

48hr,then reduce as per

response

Gatifloxacin 0.3%

ophthalmic Solution

1drop 1 hourly for 1st

48hrs then reduce as

per response

Moxifloxacin.

Preferable.

Treatment may fail

against MRSA.

Acute Bacterial

(Contact lens users)

P.aeruginosa

Tobramycin or Gentamicin

14mg/ml + Piperacilin or

Ticarcillin eye drops (6-

Ciprofloxacin

ophthalmic 0.3% or

Levofloxacin


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12mg/mL) q15-60 min around

the clock 24-72hr,then slowly

reduce frequency

ophthalmic 0.5%

Fungal keratitis

Aspergillus,

Fusarium,

Candida and others

Natamycin (5%) 1drop 1-2

hourly for several days,then 3-

4 hourly for several days

depending on response

Amphotericin B

(0.15%) 1 drop q1-2

hourly for several days

depending on the

response

Empirical therapy

is not

recommended.

Protozoan

(soft contact lense

users)

Acanthamoeba spp.

Optimal regimen uncertain

Suggested –(Chlorhexidine

0.02% or

Polyhexamethylenebiguanide

0.02%) +

(Propamidineisethionate

0.1%or Hexamidine 0.1%)

eye drops 1drop every 1

hourly hourly during day time,

taper according to clinical

response

-

Uncommon.Traum

a & soft contact

lenses are risk

factors

Orbital infections

Orbital cellulitis

S.pneumoniae,

H.influenzae,

M.catarrhalis,

S.aureus,

Anaerobes,

Group A

Streptococcus,

Occasionally Gram

Negative bacilli

post trauma.

Cloxacillin 2 gm IV q4h+

Ceftriaxone 2 gm IV q24

hourly+ Metronidazole 1gm

IV 12h

If

Pencillin/Cephalospori

n allergy:

Vancomycin 1gm iv

q12h + levofloxacin

750 mg IV once daily +

Metronidazole iv 1gm

24h

If MRSA is

suspected substitute

cloxacillin with

Vancomycin

Endophthalmits

Bacterial

Post-ocular surgery

S.epidermidis

S. aureus, Streptococci,

enterococci, Gram- negative

bacilli

Immediate

ophthalmological

consultation.

Immediate vitrectomy+

intravitreal antibiotics

(Inj Vancomycin + Inj

ceftazidime)

.

Adjuvant systemic

antibiotics

( doubtful value in

post cataract

surgery

endophthalmitis)Inj

Vancomycin+ Inj

Meropenem

Hematogenous

S.pneumoniae, N.meningitidis,

S. aureus,

Group B streptococcus,

K. pneumoniae

Intravitreal antibiotics

Inj Vancomycin + Inj

ceftazidime

+

Systemic antibiotics

Inj Meropenem 1gm iv

q8h /Inj Ceftriaxone

2gm iv q24h + Inj

Vancomycin 1g iv

q12h

Endophthalmitis

Mycotic (Fungal)

Candida sp,

Aspergillus sp.

Intavitreal amphotericin B

0.005-0.01 mg in 0.1 ml

Systemic therapy:

Amphotericin B 0.7-1mg/kg +

Flucytosine 25mg/kg qid

Liposomal

Amphotericin B 3-

5mg/kg

Or

Voriconazole

Duration of

treatment 4-6

weeks or longer

depending upon

clinical response.

Patients with


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chorioretinitis and

ocular involvement

other than

endophthalmitis

often respond to

systemically

administered

antifungals

J. EAR INFECTIONS

Ear infection Likely Etiology/ Suggested Regimen Alternate Remarks

Malignant otitis externa P. aeruginosa (in

>90% cases)

Piperacilin+Tazobactam

4.5gm IV 6h Or

Imipenem/Meropenem

Ciprofloxacin

Ceftazidime Debridement usually

required. Rule out

osteomyelitis; Do CT or

MRI, If bone involved ,

treat for 4-6 wks.

Acute otitis media

S. pneumoniae

H. influenzae

Morexella

catarrahalis

Amoxicillin+clavulanate

90/6.4mg /kg/day bid or

cefpodoxim /cefuroxime

axetil 250mg BD

Ceftriaxone

50mg/kg I/M

for 3 days

Treat children <2 years

If >2 years, afebrile and

no ear pain- consider

analgesics and defer

antibiotics

Duration of treatment

If age <2 years: 10 days

If age >2 years : 5-7

days

Mastoiditis

Acute S.pneumoniae

S.aureus

H.infiuenzae

P.aeruginosa

Cefotaxime 1-2 gm iv 4-8

hourly

Ceftriaxone 2 gm iv OD

Modify as per culture

Unusual causes-

Nocardia, TB,

Actinomyces.

Chronic Polymicrobial Piperacillin- tazobactam 4.5g

IV 8h

Meropenem 1 gm iv 8h

Acute

Pharyngitis/tonsillitis

Exudative/Diffuse

Erythema

Mostly viral

Group A, C, G

Streptococcus,

Infectious

mononucleosis,

Penicillin V oral x10 days or

Benzathine Penicillin 1.2

MU IM x 1 dose or Cefdinir

or cefpodoxime x 5 days

Penicillin allergic,

Clindamycin 300-450

mg orally 6-8 hourly x 5

days. Azithromycin

clarithromycin are

alternatives.

Membranous pharyngitis C.diptheriae, Erythromycin 500 mg IV

QID or Penicillin G 50,000

units/kg IV 12 hourly.

Diptheria antitoxin: Horse

serum.

<48 hrs:20,000-40,000 units,

Nasopharyngeal

membranes:40,000-60,000

units

>3 days & bull neck :

80,000-1,20,000 units

Epiglotitis(Supraglotis)

Children:

H.influenzae ,

S.pyogenes,

S.pneumoniae,

S.aureus.

Cefotaxime 50 mg/kg IV 8

hourly or ceftriaxone 50

mg/kg IV 24 hourly

Levofloxacin

10 mg/kg IV

24 hourly +

clindamycin

7.5 mg/kg IV 6

hourly.


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Adult: Group A

Streptococcus ,

H.influenzae

Laryngitis(hoarseness) Viral (90%) No antibiotic indicated

K. INFECTIONS IN BURNS PATIENTS


Organism

Empiric antibiotics

Alternative

antibiotics

Comments

For burns wound that is

clinically or

microbiologically not

infected

Prophylactic parenteral

antibiotics in burns are

NOT indicated

Topical antibiotics to be

given after debridement

For burns wound that are

clinically or

microbiologically infected

Strep pyogenes,

Enterobacter sp.,

S. aureus,

S. epidermidis,

Pseudomonas,

fungi (rare)

i. Burn wound sepsis

Pipercillin-tazobactam

or

Cefoperazone-sulbactam

or

With or without:

Vancomycin

//Teicoplanin

(if there is suspicion for

MRSA)

Antifunal Therapy –

When extensive burns

and patient not

responding to antibiotics

o If hemodynamically

stable: fluconazole

o If hemodynamically

unstable:

Echinocandin

Burn wound cellulitis

Cefazolin

or

Clindamycin

or

Vancomycin if there is

suspicion for MRSA

With and without (for burns

involving the lower extremity

or feet or burns in patients

with diabetes)

Pipercillin-tazobactam

or

cefoperazone-sulbactam

Carbapenem

+/-

Vancomycin/

Teicoplanin

Antibiotic choices are

dependent on the

antibiogram of the

individual institution.

Surgical debridement as

necessary.

Amphotericin B is toxic

to all burn patient as

renal system

compromised, hence

Caspofungin may be

used.

Prophylaxis in Plastic Surgery

Surgical prophylaxsis: Inj Cefuroxime 1.5 g/ Cefazolin IV just before incision single dose.


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L .FUNGAL INFECTIONS

Routine antifungal prophylactic therapy in critically ill patients is NOT recommended. Fungal therapy is usually started

based on positive cultures or systemic evidence of fungal infection. It is advised to take paired cultures if fungal infection is

suspected. Evidence includes persistent sepsis / SIRS despite broad spectrum antibiotic (exclude sepsis, abscess, drug fever,

DVT etc). Treat according to identification and antifungal sensitivity of Candida isolate.

Fluconazole IV/oral 800 mg OD first day (12mg/kg) and then 400 mg OD (6mg/kg from second day) if fluconazole

naïve or sensitive

Or

2nd

line Liposomal Amphotericin B (for Candida krusei and C.glabrata as inherently resistant to Fluconazole.) or

Caspofungin (As Caspofungin is inherently inactive against Zygomycetes, Cryptococcus, Fusarium and

Trichosporon Spp) Liposomal Amphotericin B IV 3mg/kg OD or Caspofungin dose: IV 70mg on Day 1 (loading),

50mg OD (<80kg) or 70mg OD (if >80kg) thereafter.Moderate to severe hepatic dysfunction: reduce the subsequent

daily dose to 35mg OD. Check for drug interactions.

To be decided by Microbiologist/ID physician based on patient’s hepatic / renal functions/Severity of infection /drug

interactions e.g. rifampicin, carbamazepine, phenytoin, efavirenz, nevirapine, cyclosporin, dexamethasone, tacrolimus

etc.

M. FEBRILE NEUTROPENIA

Febrile Neutropenia- definition

Neutropenia-ANC<500/mm3 and expected to fall below 500/mm

3 in 48hrs

Fever -single oral temperature of 38.3oC (101

0 F) on one occasion or 38

oC (100.4

0 F) on at least 2 occasions (1 hour

apart)

Neutropenic patients may not have usual signs of infection. Redness, tenderness and fever may be the only signs.

Protocol:

Critical examination of areas usually harboring infections, including but not limited to, oral cavity, axillary region,

scalp, groin, perineal region.

Send blood Cultures 2 sets (each bottle 10ml x 4 bottles)

Other relevant investigations: urea, creatinine, ALT, urine culture, Chest Xray, separate culture from central line, etc.

Patient-Haemodynamically stable

Blood culture 2 sets

Start IV Ceftazidime

No need to add glycopeptide in the initial regimen (except in specific situations, given below)

Patient-Haemodynamically unstable

Start BL-BLI agent (Cefoperazone-Sulbactam/piperacillin-tazobactam)

OR

Carbapenem (meropenem/imipenem/doripenem)

No need to add glycopeptide in the initial regimen (except in specific situations, given below)

Reassess after 48 hours:

If blood cultures are negative, haemodynamically stable but still febrile

Reculture blood

Add amikacin for 3 days

Add colistin (instead of amikacin) if indicated (see below)

If blood cultures are negative, haemodynamically unstable but still febrile

Inj Colistin (+/-Carbapenem) + glycopeptide + Echinocandin/L-Ampho B

Blood culture growing Gram negative bacilli

Patient afebrile - continue the empirical antibiotic till antibiotic sensitivity is available.

Rationalise as per susceptibility profiles

When to add glycopeptides?

1. Haemodynamic instability, or other evidence of severe sepsis, septic shock or pneumonia

2. Colonisation with MRSA or penicillin-resistant S. pneumonia


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3. Suspicion of serious catheter-related infectione.g. chills or rigours with infusion through catheter and cellulitis

around the catheter exit site

4. Skin or soft-tissue infection at any site

5. Positive blood culture for gram-positive bacteria, before final identification and susceptibility testing is available

6. Severe mucositis

When to add empirical colistin in febrile neutropenic patients?

1. Heamodynamic instability.

2. Colonisation with carbapenem resistant gram-negative bacteria.

3. Previous infection with carbapenem resistant gram-negative bacteria.

4. GNB in blood, sensivity pending, persistent fever with haemodynamic instability.

Empirical Antifungal Therapy

No response to broad spectrum antibiotics (3-5 days)-add L-Ampho B / echinocandin

When a patient is located at a remote area and may not have access to emergency healthcare services, febrile

neutropenia can be lifethreatening. Under such circumstances, availability of broad-spectrum oral antibiotics with the

patient can help them gain time to reach emergency healthcare service.

Useful tips

Febrile after 72 hrs-CT chest and consider empirical antifungal.

If fever persists on empirical antibiotics, send two sets blood cultures/day for 2 days

Send further cultures if clinical deteriaration Unexplained persistent fever in otherwise stable patient doesn’t require change in empirical antibiotic regimen.

Continue the regimen till ANC is >500 cells/mm3

If glycopeptide started as a part of empirical regimen, STOP after 48 hrs, if no evidenc of Gram positive infection

Antibiotic treatment should be given for at least seven days with an apparently effective antibiotic, with at least four

days without fever.

Once Neutrophil count has recovered, with no culture positivity and heamodynamically stable; antibiotics can be

stopped and patient observed, even if remains febrile. Evaluate for fungal infection, if at risk.

Antibiotic Prophylaxis

Though quinolone prophylaxis is recommended by International guidleines, it is not useful in Indian scenario due to high

resistance.

Antiviral prophylaxis

For HSV IgG positive patients undergoing allo-HSCT or leukemia induction needs acyclovir prophylaxis

All patients being treated for cancer need to receive annual influenza vaccination with an inactivated vaccine.

Neutropenic patients presenting with influenza like illness should receive empirical treatment with neuraminidase

inhibitor.

Antifungal prophylaxis

a) Induction chemotherapy of Acute Leukemia: Posoconazole

b) Post allo BMT

Pre engraftment: Voriconazole/echinocandin

Post engraftment: Posoconazole


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N. POST-CARDIOVASCULAR SURGERY INFECTIONS

Surveillance regarding the Infections following CTVS should be done in each institute

1. Antibiotic Prophylaxis to be guided by the institutional prevalence of MRSA infection and in patients at increased risk for

MRSA colonization

2. Nasal screening before CTV surgery is recommended to rule out MRSA colonization

S.

no.

Surgery

Antibiotic Prophylaxis

Comments

1st line 2

nd line Special

Antibiotic/Combination

1. CABG Cefazolin Cefuroxime - Vancomycin /Teicoplanin to be used

in case of high prevalence of MRSA

infections only

Using only Vancomycin/Teicoplanin

is NOT recommended due to lack of

coverage of GNB

Vancomycin infusion to be given

over 1 hour & to be started 2 hrs

before the surgical incision

Teicoplanin dosing to start with 800

mg x 3 doses and then 6 mg/kg to

complete prophylxis

Duration of Prophylaxis: Continued

till 48 hours after the surgery

Empirical Treatment after appropriate specimen for stain & cultures have been collected

S.

no.

Infection/

Syndrome

Likely

Causative

agents

Antibiotics Comments

1st line 2

nd line Special Antibiotic/

Combination

1 Sternotomy site

infection

Not known BL-BLI

(Piperacillin-

tazobactam,

Cefoperazone-

sulbactam, cefipime-

tazobactam) with or

without amikacin.

With

Vancomycin/

teicoplanin

Daptomycin/

Linezolid with

carbapenem

Consider de-

escalation to

TMP/SMX ,

doxy/minocycline,

cloxacillin, cefazolin,

If these are sensitive

1) Removal of

the foreign

body (steel

wires) should

be considered

2 Infection of

vascular

catheters

Not known BL-BLI

(Piperacillin-

tazobactam,

Cefoperazone-

sulbactam, cefipime-

tazobactam) with or

without amikacin

withVancomycin/

teicoplanin

Carbapenem

(Empirical

anti-MRSA

drug if the

incidence of

MRSA CRBSI

is high)

Consider de-

escalation as per the

isolate,

susceptibility,

MICs, adverse

effects, drug allergy

3 Pneumonia Not known BL-BLI

(Piperacillin-

tazobactam,

Cefoperazone-

sulbactam) with or

without amikacin

Carbapenem

Consider de-


isolate,

susceptibility,

MICs, adverse


4 Mediastinitis Not known BL-BLI

(Piperacillin-

tazobactam,

Carbapenem

with or

without

Consider de-


isolate,


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Cefoperazone-

sulbactam) with or

without amikacin

With Vancomycin/

teicoplanin

Amikacin

susceptibility,

MICs, adverse


5 Urinary tract

infection

Not known BL-BLI

(Piperacillin-

tazobactam,

Cefoperazone-

sulbactam with or

without amikacin

Carbapenem

with or

without

Amikacin

Consider de-


isolate,

susceptibility,

MICs, adverse


Definitive Treatment after appropriate specimen for stain & cultures have been collected

S.

No.

Infection/

Syndrome

Likely

Causative

agents

Antibiotics Comments

1st line 2

nd line Special Antibiotic/

Combination

1 Sternotomy site

infection

Coagulase

Negative

Staphylococc

i

MRSA

Enterococcus

GNB (Enterobacteri-

-acae,

Pseudomonas,

Acinetobacter)

Candida

Vancomycin,

Teicoplanin

Vancomycin,

Teicoplanin,

Vancomycin,

Teicoplanin,

BL-BLI

(Piperacillin-

tazobactam,

Cefoperazone-

sulbactam, with or

without amikacin

L-AmB/AmB-d for

3 weeks followed by

Fluconazole

(If susceptible)

Daptomycin

Linezolid

Daptomycin

Linezolid

Carbapenem

(Meropenem,

Imipenem)

Consider de-escalation

to Cotrimoxazole or

Cloxacillin or

Cefazolin


to TMP/SMX or

doxy/minocycline

If these are sensitive


to Ampicillin/ Ampi-

sulbactam


to oral agent if

possible after 2-6

weeks of antibiotic

therapy

De-escalation to

Fluconazole 800 mg

loading followed by

200 mg BD

1) Consider

MICs, risk of

nephrotoxicity

, bone

penetration

for choosing

the antibiotic

2) Removal of

the foreign

body (steel

wires) should

be considered

3) Longer

duration of

duration – 6-

12 months

may be

required

For Candida

osteomyelitis,

longer duration of

treatment (12

months) is

recommended


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O. PEDIATRIC INFECTIONS

Specific Conditions

For Infant below 2 months age (more than 2kg):

Antibiotic Each dose Frequency Route Duration

<7 days >7days

Inj. Cefotaxime + Inj.

Gentamicin

50 mg/kg/dose

5 mg/kg/dose

12 hrly 8 hrly

24 hrly 24 hrly

IV

IV

2-3 weeks

2nd line therapy:

Meropenem+

Vancomycin

20 mg/kg/dose

15 mg/kg/dose

12 hly 8hly

12 hly 8hly

IV

2-3 weeks

Treat bacterial meningitis due to Gram-negative bacilli or Staphyloccocus sp for at least 21 days.

For 2 months and above –

Inj Ceftriaxone (100mg/kg/day-2 divided dosage) for 10 -14 days

2nd line therapy: Meropenem (120 mg/kg/day in 3 div doses) + Vancomycin (60mg /kg/day in 4 div doses) for 10-14 days

In case Ceftriaxone is not available, Inj Cefotaxime (200mg/kg/d, 3-4 divided doses) is given for the same duration.

However if strong clinical suspicion for Staphylococcus infection in the form of skin boils, arthritis or flowing

external wounds – Inj. Vancomycin can be added. In such situations the regimen is given for minimum period of 3

weeks.

With confirmed meningococcal disease, treat with intravenous Ceftriaxone for 7 days

H influenzae type b meningitis is treated with intravenous Ceftriaxone for 10 days

S pneumoniae meningitis is treated with intravenous Ceftriaxone for 14 days

Bacterial meningitis due to Staphyloccocus sp is treated for at least 21 days.

Chemoprophylaxis for Meningococcal Disease Contacts (including non-vaccinated Hospital Staff): To be effective in

preventing secondary cases, chemoprophylaxis must be initiated as soon as possible (i.e. not later than 48 hours after diagnosis

of the case). Mass chemoprophylaxis not needed.

Drug Dose (Adults) Dose (Children) Route Duration

Rifampicin 600mg/12hr 10mg/kg/12hr Oral Two Days

Ciprofloxacin 500mg - Oral Single Dose

Ceftriaxone 250mg <15yr – 125mg IM Single Dose

Azithromycin 500mg 10mg/kg Oral Single Dose

1) LOWER RESPIRATORY TRACT INFECTION –

Community acquired Pneumonia is categorized in to 2 types –Severe pneumonia (those with respiratory distress) and

pneumonia (those with fast breathing only, treated on OPD basis).

(a) For Severe Pneumonia (Children with respiratory distress requiring indoor care)-

Under 2 months of age:

o Inj Cefotaxime / Ceftriaxone and Gentamicin for 10 days

Over 2 months of age:

o Inj. Ampicillin (50mg/kg/dose 6h) + Gentamicin (7.5mg/kg/day OD i.m or i.v) is used. Inj Ampicillin

can be switched to Oral Amoxycillin (45mg/kg/day TDS) once child is stable and able to take oral feeds.

Total treatment duration is 7-10 days.

o In case of no response in 2 days the patient is assessed for complications like empyema, or infection at

any other site. In the absence of any complication, a 3rd

generation Cephalosporin (Cefotaxime

50mg/kg/dose 6h or Ceftriaxone 75- 100mg/kg/day in two divided doses, IV ) is used and can be


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switched to oral Cefopodoxime (10mg/kg/day BD) once the child is able to take orally. Total treatment

duration is 7-10 days.

o In case the patient has severe sepsis/ septic shock, Inj. Piperacillin + Tazobactam (90mg/kg/dose 6h) +

MRSA cover with IV Vancomycin (15mg/kg/dose 6h) is recommended.

Whenever Staphyloccus aureus is suspected in children (see Text Box), the various drug options are:

In severe pneumonia, use Inj.Cloxacillin or Inj Clindamycin may be added to the initial regime. OR

Oral or IV Co- Amoxyclavulanic acid can be used.

In very severe necrotizing pneumonia or for a patient in septic shock, MRSA cover should be added with IV

Vancomycin Vancomycin 25-30 mg IV loading followed by 15-20 mg/kg 8-12 Hourly /)/ Teicoplanin 12 mg/kg x3

doses followed by 6 mg/kg once a day or Linezolid (10mg/kg/dose 8h).

The total duration for treatment for uncomplicated Staphylococcal pneumonia is 3-4 weeks.

(b) For pneumonia (OPD)

Oral Amoxicillin (45mg/kg/day TDS) for a period of 5 days is recommended as the first choice. In case of non

availability, one may use oral Co-trimoxazole (8mg/kg/day of TMP component BD).

Routine use of macrolide antibiotics for all cases of pneumonia is not advocated. Recent data suggests that (i) the routine

addition of macrolides to children with CAP does not improve outcome (ii) selective use of macrolides would reduce their

indiscriminate use and reduce antibiotic resistance.

Classically the mycoplasma pneumonia presents in an atypical fashion but literature suggests that it can sometimes be difficult

to distinguish mycoplasma pneumonia from a pyogenic pneumonia.

Macrolide antibiotics should be considered in following clinical scenarios where the likelihood of mycoplasma pneumonia is

high:

a. Children with a subacute presentation with prolonged low grade fever, persistent cough, chest signs out of

proportion to the radiographic abnormality (usually showing perihilar streaky infiltrates).

b. Children with CAP (acute pneumonia like presentation with radiological evidence of patchy or lobar

consolidation) who also have or develop extrapulmonary manifestations like myocarditis, hemolytic

anemias, glomeruonephritis, aseptic arthritis, CNS problems (aseptic meningitis, encephalitis, ataxia), etc.

c. Non response to first line antibiotics in children who are immunized with Hib/PCV and have no suppurative

complications of CAP.

In the first two conditions macrolide antibiotics can be used along with the first line therapy for CAP.

EMPYEMA

• Proper drainage : Forms the main core of treatment.

Antimicrobial Therapy:

Anti- Staphylococcal penicillin (Cloxacillin 100-200 mg/kg/day) along with 3rd generation cephalosporin like

Ceftriaxone may be used as first line drug.

Co-Amoxyclav is alternative first line therapy.

It is important to have high index of suspicion for staphylococcal infection as the initial

choice of antibiotic does not cover this less common but a more severe infection

adequately. Staphylococcal pneumonia is suspected if any child with pneumonia has:

Rapid progression of the disease, or

Pneumatocele, or Pneumothorax, or Effusion on chest X-ray, or

Large skin boils or abscess or infected scabies or

Post-measles pneumonia, which is not responding within 48 hours to the initial

therapy.

To cover for staphylococcal infection, Cloxacillin or other antistaphyloccal drug

should be added to the initial regimen as discussed in the text.


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In seriously ill patients with disseminated staphylococcal disease and septic shock to cover for MRSA,

Vancomycin is recommended. Vancomycin is less effective than the first line drugs for the commoner

Methicillin sensitive strains of Staphylococcus aureus.

Children may continue to be febrile for 5-7 days after starting antibiotic therapy in the case of S. pneumoniae and

H. influenzae and for 10-14 days in the case of Staphylococcus aureus. The clinical response to therapy should be

assessed with parameters such decrease in fever, normalization of lab parameters such as CBC count, CRP,

decrease in drain volume, clearing in chest x-ray, improvement in the overall condition of the patient.

The decline in toxicity and fever are good signs of likely response. In case of complete non response after 96

hours of treatment, high spiking fever and persistent drainage, second line treatment may be instituted.

Vancomycin should be substituted instead of the first line cloxacillin or co-amoxyclav.

All children with non response should be evaluated for presence of pus pockets in the pleural cavity by an

ultrasound chest. Here the key lies in better drainage rather than in a change of antibiotics. Extraneous causes of

fever should also be evaluated.

VENTILATOR ASSOCIATED PNEUMONIA:

Treat as per the sensitivity pattern of your ICU.

General Suggestion:

Potential Pathogens Combination antibiotic therapy

Pseudomonas aeruginosa

Or

Klebsiella pneumonae (ESBL)

Or Acinetobacter species

Beta Lactam + beta lactamase inhibitor (Piperacillin – Tazobactam)

Plus

Either

Aminoglycoside (Amikacin, Gentamicin, or Tobramycin)

OR

Antipseudomonal fluroquinolone (Cipro/ Levofloxacin)

Methicillin – resistant

Staphylococcus aureus (MRSA)

Vancomycin or Linezolid

Second line Therapy

Meropenem – 60 mg/kg/day I/V every 8 hrly AND Vancomycin - 40 mg/kg/day I/V every 6 - 8 hrly

Third line Therapy

Colistin base IV., 2.5 – 5 mg/kg/day I/V every 6 – 12 hrly (1mg= 30000 IU) AND Vancomycin - 40 mg/kg/day

I/V every 6 - 8 hrly

UPPER RESPIRATORY TRACT INFECTIONS

As these are mostly viral in origin, antibiotics are not needed barring following situations.

(a) Bacterial Pharyngotonsillitis (Group A Streptococcus) –

Any of the following Antibiotic

(route)

Children (<30kg) (days) Children (>30kg) (days)

Penicillin V (Oral) 250 mg BID x 10 days 500 mg BID x 10 days

Amoxycillin (Oral) 40 mg/kg/day x 10 days 250 mg TID, can be given BID

Benzathine Pencillin G (IM) 6 Lakh units (Single Dose) 12 Lakh units (Single Dose)

While Penicillin is the drug of choice Amoxycillin is good alternative and used widely.

If the patient is Pencillin allergic, the alternative drugs are

Antibiotic (route) Dose and duration

Erythromycin (oral) 40-50 mg/kg/day BID or TID x 10 days

Azithromycin (oral) 12 mg/kg OD x 5 days

First Generation Cephalosporin (oral) (10 days) (if only,

it is non Type 1 allergy to penicillin)

Cefaclor (20-40 mg/kg/d in 3 divided doses) /

Cephalexin (50 mg/kg/d in 3 divided doses)

(b) Faucial diphtheria

Inj.Crystalline Penicillin (100,000-150,000 Units/kg/day I.V 6h) for 10 days in recommended. Alternativey,

Inj.Procaine Penicillin 25,000-50,000 U/kg/day BD maximum of 12 lakh units i.m. can be used.

In case of penicillin allergy, Erythromycin (40-50mg/kg/day TDS/QID for 14 days or Azithromycin 10mg/kg/day

OD for 5 days can be given.


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(c) Acute otitis media (AOM) –

Oral Amoxicillin (45mg/kg/day TDS/50-60mg/kg/day in two divided doses) for 7 to 10 days is recommended.

For severe cases (Severe Otalgia and/ or Temp >390C), Co-Amoxycillin Clavulanate (45 mg/kg/day po BD) or

Inj.Ceftriaxone 75 mg/kg/day OD can be used.

In case of penicillin allergy, Cefidinir (14 mg/kg/d in 2 divided doses) can be used

Total duration of treatment is recommended for 7 to 10 days.

(d) Mastoiditis And Other Acute Ear Infection

Inj. Amoxicillin-clavulanate OR 3rd Gen Cephalosporin (Ceftriaxone/ cefotaxime).

(e) CSOM

Routinely systemic antibiotic is not recommended until there is exacerbation and these are referred to ENT

(f) Acute Sinusitis with URI-

Oral Amoxycillin (45 mg/kg/day TDS) for 7-10 days is recommended. For severe

cases, Amoxycillin Clavulanate (45 mg/kg/day oral BD) or Inj.Ceftriaxone 75 mg/kg/day OD can be used.

(g) Ludwig’s Angina

1st line : Clindamycin IV 8 hourly or Amoxicillin-Clavulanate IV

2nd

line : Piperacillin-Tazobactam IV 6 hourly

(h) Pertussis

Erythromycin for 14 days, Azithromycin for 5 days, Clarithromycin for 7 days and have similar efficacy but differ in

terms of cost, duration of therapy, side effects, tolerability, likelihood of drug interaction. Considering all factors,

Azithromycin in a dose of 10 mg/kg once a day for 5 days in infants less than 6 months and 10 mg/kg on day 1 and

then 5 mg/kg day on 2 to 5 days is the cheapest, shortest best tolerated and most convenient option and can be safely

given to infants less than 1 month (unlike all other macrolides).

GASTRO-INTESTINAL DISEASES

(1) Dysentery

(a) For inpatients- Inj Ceftriaxone (100mg/kg) for 5-7 days.

(b) For OPD cases

Cefixime (8mg/kg/day BD)

Or

Azithromycin 10-20 mg/ kg (ceiling dose of 1 gm) for 5 days.

In case of non response after 2 antibiotics, investigate for appropriate therapy.

Fluoroquinolones are not preferred due to high level of resistance in many parts of the country.

(2) Cholera

Single dose oral azithromycin 10 mg/ kg (ceiling dose of 1 gm) or Doxycycline (50mg for less than 3 years

and 100 mg for those above).

(3) Enteric Fever

(a) For OPD cases-

Oral Cefixime 20 mg/kg/day (max dose of 1200) for 14 days or azithromycin 10-20 mg/kg (ceiling dose of 1

gm) for 7-10 days. Antibiotic therapy should be continued till one week post-fever defervescence.

(b) For inpatients

Inj Ceftriaxone 100 mg/ kg/day and shift to oral cefixime once fever resolves. Antibiotic therapy should be

continued till one week post-fever defervescence.

Second line:

a) Ofloxacin 15mg/kg/d in two divided doses for 10-14 days. Antibiotic therapy should be continued till one

week post-fever defervescence.

b) Chloramphenicol (50- 75mg/kg/day PO) x 14 days

c) TMP-SMX (8 mg/kg/day of TMP PO) x 14 days


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(4) Peritonitis For primary peritonitis in nephrotic syndrome: Inj. Ampicillin + Aminoglycoside OR inj. cefotaxime

for primary peritonitis in a cirrhotic, inj. cefotaxime.

(5) Liver Abscess

1st Line 2

nd Line

Amoxycillin-clavulanate/ 3rd

generation cephalosporin

+

Aminoglycoside

Metronidazole (30-50 mg/kg/d in 3 divided doses for

10-14 days) is added if Amoebic abscess suspected

Piperacillin-

Tazobactam IV

Ultrasound guided drainage

indicated in large abscesses,

signs of imminent rupture and

no response to medical

treatment.

Total duration of therapy is 4-6 weeks

URINARY TRACT INFECTION (UTI)

a) Uncomplicated UTI (age> 2 months with lower UTI, without any urinary tract obstruction) – Oral Cotrimoxazole (8-10mg of TMP component) /kg/day oral BD

OR

Cefixime (8-10 mg/kg/day BD) to be given for 7-10 days

OR

Co Amoxycillin+Clavulanic Acid (30-50 mg of Amoxicillin) for 7-10 days.

b) Complicated / Severe UTI (Febrile UTI, Systemic toxicity, renal angle tenderness or with any urinary

structural abnormality) and all UTI in children less than 2 months should be treated with parenteral

antibiotics.

Inj. Cefotaxime (150-200mg/kg/day 8h OR

Inj. Ceftriaxone (100mg/kg/day OD OR

Inj. Amikacin 15mg/kg OD

To be given for 10-14 days

c) In Immunocompromised host/ severe systemic sepsis or as second line for complicated UTI-

Inj. Piperacillin Tazobactum 90mg/kg/dose IV 6h) or Inj. Meropenem (20-40mg/kg/dose 8h) To be given for

10-14 days

FEBRILE NEUTROPENIA

1st Line 2nd Line 3rd Line

Ceftazidime (150 mg/kg/day in

3div doses)+ Amikacin (15-

20mg/kg/day in 2 or 3 div doses)

Piperacillin + Tazobactam (200-

300 mg/kg/day IV in 3-4 div

doses)+ Vancomycin (40

mg/kg/day IV in 4 divided doses)

Meropenem (60 mg/kg/day in 3 div

doses) + Amphotericin B (1

mg/kg/day IV for 2 weeks) or

liposomal Amphotericin B 1-5 mg

kg/day, usually 3 mg/kg/day

Patients without an identified etiology who become afebrile within first 3-5 days of therapy and are clinically well

with ANC of > 200 cells/cmm can be shifted to oral antibiotics (Cefixime or Co- Amoxy- Clavulanic acid) and

therapy should be continued for minimum 7 days.

However, if fever persists or ANC remains <200 parenteral therapy should be continued with 2nd line antibiotics

In clinically stable patients without an identified etiology but with persistent neutropenia, therapy can be stopped after

2 weeks.


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Presumptive therapy for initial antimicrobial coverage in critically ill children with severe sepsis and septic shock

Antibiotics should be administered within 1 hour of the identification of severe sepsis and septic shock, if possible, after

obtaining appropriate cultures. The initial empiric antibiotic therapy should include one or more drugs that have activity

against the likely pathogens and that penetrate the presumed source of sepsis. Initially, broad antibiotic coverage is

recommended. Following are the general rules which can help for decision making:

I. All children with septic shock should receive coverage for methicillin-resistant Staphylococcus aureus (MRSA)

initially at recognition of the event.

II. Coverage for enteric organisms should be added whenever clinical features suggest genitourinary

and/or gastrointestinal sources (eg, perforated appendicitis or bacterial overgrowth in a child with short gut

syndrome).

III. Treatment for Pseudomonas species should be included for children who are immunosuppressed or at risk for

infection like those with cystic fibrosis).

IV. When treating empirically, antibiotics which can be given by rapid intravenous bolus (eg, beta-lactam agents or

cephalosporins) should be administered first followed by infusions of antibiotics, such as vancomycin, that must be

delivered more slowly.

V. Ongoing antimicrobial therapy should be modified based upon culture results, including antimicrobial susceptibility

and the patient's clinical course.

Suggested initial empiric antimicrobial regimens based upon patient age, immunocompetence, and previous antibiotic

administration include:

1. Children >28 days of age who are normal immunocompetent patient:

a) Ceftriaxone/Cefotaxime plus Vancomycin //Teicoplanin

c) Consider adding an aminoglycoside (eg, gentamicin/amikacin) if possibility of genitourinary source is likely

d) Consider adding piperacillin-tazobactam / clindamycin / metronidazole if possibility of gastro-intestinal source

2. Children >28 days who are immunosuppressed or at risk for infection with Pseudomonas species:

a) Ceftazidime or Cefepime plus Vancomycin/Teicoplanin

b) add an aminoglycoside or carbapenem in settings where bacterial organisms with extended-spectrum beta-lactamase

(ESBL) resistance are prevalent.

c) addition of a carbapenem is favored over an aminoglycoside if the patient has received any broad-spectrum antibiotics

like 3rd

generation cephalosporin, aminoglycoside or fluoroquinolone within two weeks.

3. Children who cannot receive penicillin or who have recently received broad-spectrum antibiotics:

a) Vancomycin/Teicoplanin plus Meropenem*

* Alternatives to Meropenam

i) Aztreonam OR

ii) Ciprofloxacin plus Clindamycin

4. Patients at increased risk of fungal infection (immunocompromised with persistent fever

on broad spectrum antibiotics) or with an identified fungal source.

Add the following antifungals to the antimicrobial regimen

a) Liposomal Amphotericin B or

b) an echinocandin (eg, caspofungin, micafungin)

5. Patients with risk factors for rickettsial infection (eg, travel to or reside in an endemic region):

Add a tetracyclin antibiotic (eg, doxycycline) to the antimicrobial regimen

The empiric drug choice should be in accordance with the ongoing epidemic and endemic infections eg, H1N1, methicillin-

resistant S. aureus, chloroquine-resistant malaria, penicillin-resistant pneumococci.

Control of the Infection Source

The source of the infection should be located and treated early and aggressively. Conditions requiring debridement or drainage

include necrotizing pneumonia, necrotizing fasciitis, gangrenous myonecrosis, empyema, and abscesses. Perforated viscus

requires repair and peritoneal washout. If intravascular access devices are a possible source of severe sepsis or septic shock,

they should be removed promptly after other vascular access has been established.

Duration of antibiotic therapy for sepsis

It will depend on the foci of infection, immune status of the patient and response to the antibiotics. If there are no

complications the duration of therapy is 7-10 days. Longer courses may be appropriate in patients who have a slow clinical

response, undrainable foci of infection, bacteremia with S. aureus; some fungal and viral infections or immunologic


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http://www.uptodate.com/contents/vancomycin-pediatric-drug-information?source=see_link

http://www.uptodate.com/contents/gentamicin-pediatric-drug-information?source=see_link

http://www.uptodate.com/contents/piperacillin-drug-information?source=see_link

http://www.uptodate.com/contents/clindamycin-pediatric-drug-information?source=see_link

http://www.uptodate.com/contents/metronidazole-pediatric-drug-information?source=see_link

37

deficiencies, including neutropenia Use of procalcitonin levels or similar biomarkers may assist the clinician in the

discontinuation of empiric antibiotics in patients.

Management of Central line/long line catheter-Related Infections -

1. Empirical coverage if suspecting gram-negative bacilli

Choice should be based on local antimicrobial susceptibility and the severity of disease a fourth-generation cephalosporin,

carbapenem, or b-lactam/b-lactamase combination, with or without an aminoglycoside).

2. Empirical antimicrobial therapy if suspecting MRSA

a. for health care settings with an elevated prevalence of MRSA- Vancomycin is recommended

b. for institutions in which the most of MRSA isolates have vancomycin minimum inhibitory concentration (MIC) values

12 mg/mL- Daptomycin, should be used.

c. Linezolid should not be used for empirical therapy.

3. Empirical combination antibiotic coverage for MDR gram-negative bacilli, such as

Pseudomonas aeruginosa, should be used when CRBSI is suspected in

a. Neutropenic patients

b. severely ill patients with sepsis

c. patients known to be colonized with such pathogens, until the culture and susceptibility data are available and de-

escalation of the antibiotic regimen can be done.

4. Empirical therapy for suspected CRBSI involving femoral catheters in critically ill patients should include coverage

for gram-positive pathogens, gram-negative bacilli and Candida species.

5. Empirical therapy if catheter-related candidemia is suspected *-

a. Echinocandin or

b. Fluconazole can be used in patients without azole exposure in the previous 3 months in health care settings where the risk

of Candida krusei or Candida glabratainfection is very low.

*It should be suspected in septic patients with any of the following risk factors: total parenteral nutrition, prolonged use of

broad-spectrum antibiotics, hematologic malignancy, receipt of bone marrow or solid-organ transplant, femoral

catheterization, or colonization due to Candida species at multiple sites.

6. Antibiotic lock therapy should be used for catheter salvage; however, if antibiotic lock therapy cannot be used, systemic

antibiotics should be administered through the colonized catheter.

Duration of antimicrobial therapy:

A. Uncomplicated Short term central venous or arterial catheter related blood stream infection

a. Coagulase negative staph:

i) treat for 5-7 days, if the catheter is removed

ii) treat for 10-14 days, if the catheter is retained

b. Staph aureus :- treat for more than 14 days

c. Enterococcus :- treat for 7-14 days

d. Gram negative bacilli :- treat for 7-14 days

e. Candida sp. :- treat for 14 days after the first negative blood culture,

B. Complicated Short term central venous or arterial catheter related blood stream infection

Four to 6 weeks of antibiotic therapy should be administered to patients with

persistent fungemia or bacteremia after catheter removal (i.e., occurring more than 72

hours after catheter removal), and to patients who are found to have infective endocarditis or suppurative

thrombophlebitis, and to pediatric patients with osteomyelitis.

BRAIN ABSCESS

Inj Ceftriaxone + Vancomycin OR

Inj Teicoplanin + Metronidazole,

Drain pus, rationalize antibiotics according to culture and sensitivity and continue for 3 to 4 week.

1. Remove the catheter

2.Treat with systemic

antibiotics


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OSTEOMYELITIS –

Co-Amoxy clavulunic + Gentamicin

SEPTIC ARTHRITIS

1 st line Inj Co-Amoxy clavulunic + Gentamicin

2nd

line Inj Ceftriaxone//cefotaxime +/- Vancomycin

TETANUS – Inj Crystalline Penicillin (2 lac IU /kg/ d /12 hourly) or Inj Metronidazole (mg/kg/d).

ACUTE ENDOCARDITIS – Inj Crystalline Penicillin/ampicillin + Gentamicin for 3-4 weeks is given which is tailored

depending upon culture & sensitivity report.

MALARIA - As per National Malaria Control Program guidelines. See chapter 8.

TUBERCULOSIS IN CHILDREN

Refer to RNTCP guidelines

ACUTE RHEUMATIC FEVER (ARF)

*Contraindicated in penicillin allergy

# maximum dose-500mg; contraindicated in liver disorders; can be given in patients with penicillin allergy; do not use if high

rates of group A streptococal macrolide resistance prevalent.

Duration for secondary prophylaxis:

It depends on the presence of carditis during the acute episode.

Antibiotic Dose Route Frequency Duration

Primary prophylaxis for rheumatic fever (Treatment of group A streptococcal tonsillo-pharyngitis)

The primary goal of treating an ARF attack is to eradicate streptococcal organisms and bacterial antigens from the

pharyngeal region. The antibiotic therapy is very effective if started within 9 days after onset of symptoms to prevent

rheumatic fever specially carditis.

Benzathine Penicillin G*

[After sensitivity testing]

According to weight of the

child

weight ≥ 27 kg :- 1.2 million units

weight < 27 kg :- 0.6 million units

Deep

intramuscular

injection

Only once

Single dose

Single dose

Alternative antibiotics

Azithromycin 12.5 mg/kg/day divided Oral OD 5 days

Amoxicillin 25–50mg/kg/day divided

Adult dose

750-1500 mg/day

Oral TDS 10 days

Cephalexin 15-20 mg/kg/dose Oral BD 10 days

Erythromycin 250 mg #OR

40 mg/kg/day divided

Oral QID 10 days

Penicillin-V 250 mg

Adult dose

500mg

Oral QID 10 days

Secondary prophylaxis for rheumatic fever

It involves continuous administration of antibiotics in patients with a previous attack of RF and/or rheumatic heart

disease. It is mandatory for all patients who have had an attack of RF, whether or not they have residual rheumatic

valvular heart disease.

Benzathine Penicillin G Same as above same same Every 3-4

weeks

Penicillin V Same same BD See below

Sulfadiazine

(patients allergic to penicillin)

weight >27 kg:- 0.5 g

weight ≥27 kg:- 1 g

oral OD See below

Erythromycin

(patients allergic to penicillin &

sufadiazine)

Same same BD See below


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1. NO carditis: continue for 5 years after last attack or 18 years of age [whichever is longer]

2. Carditis present (healed carditis or mild mitral regurgitation): continue for 10 yearsafter last attack or 25 years of age

[whichever is longer]

3. Carditis present (established heart disease or following valve surgery or ballon mitral valvotomy): continue lifelong

4. Expert consultation should be sought if want to discontinue after 40 years of age instead of life-long prophylaxis as

recurrence beyond this age is minimal.

PAEDIATRIC SURGICAL CASES

Clean Surgery Clean Surgery likely to be

contaminated

Contaminated/dirty Surgery or

Peritonitis

Surgeries like Uncomplicated

Hernia, cyst excision, hydrocoele

- No Pre-operative prophylaxis

needed

For all other surgeries under

this group:

Inj Ceftriaxone 50 – 75 mg/kg/day

I.V or I/M single dose half an

hour before surgery

For GI surgeries

Inj Ceftriaxone 50 – 75 mg/kg/day,

I.V or I/M 12 hly doses

AND

Metronidazole 20 – 30 mg/kg/day

I/V every 8 hrly

Given for 48hrs only.

Urinary tract surgeries

Inj Ceftriaxone 50 – 75 mg/kg/day

I.V or I/M 12hrly doses

Do not continue beyond 48hrs of

surgery

All surgeries under this group

Inj Ceftriaxone 50 – 75 mg/kg/day, I.V

or I/M 12hrly doses

AND

Metronidazole 20 – 30 mg/kg/day I/V

every 8 hrly

AND

Gentamicin 7.5mg/kg/d 24hrly IV or IM

2nd Line

Piperacillin + Tazobactam (200-300

mg/kg/day IV in 3-4 div doses) +

Vancomycin (40 mg/kg/day IV in 4

divided doses)

Cellulitis/ Abscesses Cloxacillin (50-

100 mg/kg/d) in

3-4 divided

doses

OR

Co- Amoxy-

Clav

OR

Cefazolin (50

mg/Kg/d in 6-8

h doses)

Clindamycin (20-

40mg/Kg/d in 6-8

hly doses)

Treat for 5-7 days.

P. NEONATAL INFECTIONS

a. SEPTICEMIA OR PNEUMONIA

1. In asymptomatic babies at high risk of sepsis eg. presence of foul smelling liquor or two or more risk factors listed

below warrants the initiation of antibiotic therapy.

Risk factors for Early onset sepsis are :

(a) Maternal fever (Temperature > 380C) before delivery or during labor

(b) Membranes ruptured for more than 24 hours before delivery.

(c) More than three vaginal examinations during labor.

(d) Low birth weight (<2500 gms) or preterm babies.

(e) Prolonged and difficult delivery with instrumentation.


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(f) Perinatal asphyxia. (Apgar < 4 at 1 min of age)

(g) Meconium stained liquor.

2. A sepsis screen should be done in such infants. If two sepsis screens (NNF protocols) done at 12 hours interval or a

single sepsis screen is negative and infant remains asymptomatic at 48 -72 hours, the antibiotics may be

discontinued.

Antibiotic Each dose Frequency Route Duration(Days)

< 7 days > 7 days

Inj. Ampicillin

And

Inj. Gentamicin

50 mg/kg/dose

5-7.5 mg/kg/dose

12 hrly 8hrly

24 hrly 24hrly

IV

IV

7-10

7-10

o In cases with severe sepsis (Sclerema/ Shock / suspicion of meningitis) Inj Cefotaxime 200 mg/kg/day IV in 4 div doses)

+ Amikacin (15mg/kg/d) is recommended

o If sepsis is suspected to be health care associated or if there is no response in 48-72 hours of initial therapy or if there is

documented resistance then change to injection Piperacillin- Tazobactam (200-300 mg/kg/day IV in 3-4 div doses) and

Amikacin.

o Vancomycin can be added to the regime if staphylococcus is suspected.

b. NEONATAL MENINGITIS

Antibiotic Dose Frequency Route Duration

(Weeks) < 7 days > 7 days

First

Line

Inj. Ampicillin and

Inj. Gentamicin

100 mg/kg/dose

5-7.5 mg/kg/d

12 hrly 8 hrly

5 mg/kg/d 7.5 mg/kg/d

24 hrly 24hrly

IV

IV

3

3

Second

Line

Inj. Cefotaxime

and

Inj. Gentamicin

50 mg/kg/dose

5-7.5 mg/kg/d

12 hrly 8 hrly

5 mg/kg/d 7.5 mg/kg/d

24 hrly 24hrly

IV

IV

3

3

Q. POST SOLID ORGAN TRANSPLANT

Post-operative infections following solid organ transplant (kidney, liver, heart, lung)


Organisms

Empiric antibiotics Alternative

antibiotics

Comments

Post-op fever with

hemodynamic stability

Usually not due to

infection

None

Look for hematoma, DVT,

transfusion related fever

Surgical site infection

S. aureus, Entero-

bacteriaceae,

Pseudomonas spp.

Treat based on culture and

sensitivities

VAP/HAP Entero-bacteriaceae,

Pseudomonas spp.,

Acinetobacter spp.

Piperacillin-

tazobactam 4.5g IV

q6h or Cefoperazone-

sulbactam 3g IVq8h

Imipenem 1g IV

q8h or

meropenem1g IV

q8h

Modify based on culture of

lower respiratory tract

secretions.


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CLABSI

S. aureus, Entero-

bacteriaceae,

Pseudomonas spp.,

Acinetobacter spp.

Candida spp.

Vancomycin loading

of 25-30 mg /kg in

patients of septic

shock followed by

15mg/kg IV 12 hourly

(maximum 1gm 12

hourly)/teicoplanin

12mg/kg IV 12 hourly

x 3 doses followed by

6 -12 mg once daily

IV depending upon

severity + Piperacillin-

tazobactam 4.5g IV


sulbactam 3g IVq8h

For 2 weeks duration

Daptomycin 6

mg/kg IV od

+Meropenem 1g

IVq8h

Draw 2-3 blood culture sets

with at least one from

peripheral sites before starting

antibiotics and modify based

on culture.

Removal of catheter must be

contemplated.

CAUTI Entero-bacteriaceae,

Enterococci

Candida spp.

Piperacillin-

tazobactam 4.5g IV


sulbactam 3g IVq8h

Imipenem 1g IV

q8h or

Meropenem 1g IV

q8h

Do blood and urine cultures

before starting antibiotics and

modify based on culture.

Removal of catheter must be

contemplated.

R. SURGICAL ANTIMICROBIAL PROPHYLAXIS

To be administered within 1 hr before the surgical incision.

Single dose is recommended. Consider for second intra-operative dosein prolong surgery based on the choice of

antibiotic used for prophylaxis.

Prophylaxis should not be given beyond surgery duration (except for cardiothoracic surgery, up to 48 hours

permissible)

Choice of the prophylaxis should be based on the local antibiogram.

SURGERY MEDICATION

Breast Inj.Cefazolin 2gm or Inj.Cefuroxime 1.5gm IV stat

Gastroduodenal & biliary Inj.Cefaperazone- Sulbactam 2gm IV stat & BD for 24hrs(maximum)

ERCP Inj.Piperacillin-Tazobactum 4.5gm or Inj.Cefaperazone- Sulbactam 2gm IV stat

Cardiothoracic Inj.Cefuroxime 1.5gm IV stat & BD for 48hrs

Colonic surgery Inj.Cefaperazone- Sulbactam 2gm IV stat & BD for 24hrs(maximum)

Abdominal surgery (hernia) Inj.Cefazolin 2gm or Inj.Cefuroxime 1.5gm IV stat

Head & Neck/ ENT Inj.Cefazolin 2gm IV stat

Neurosurgery Inj.Cefazolin 2gm or Inj.Cefuroxime 1.5gm IV stat

Obstetrics& Gynecology Inj.Cefuroxime 1.5gm IV stat

Orthopaedic

Inj.Cefuroxime 1.5gm IV stat & BD for 24 hrs(maximum)

or

Inj.Cefazolin 2gm IV stat

Open reduction of closed fracture with internal fixation- Inj.Cefuroxime 1.5gm IV stat

and q 12h or Inj.Cefazolin 2gm IV stat and q 12h for 24 hrs

Trauma Inj.Cefuroxime 1.5gm IV stat and q 12h (for 24 hrs)

or Inj.Ceftriaxone 2gm IV OD

Urologic procedures Antibiotics only to patients with documented bacteriuria

Trans- rectal prostatic surgery Inj.Cefaperazone- Sulbactam 2gm IV stat


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Chapter 3

Treatment of Muti-Drug Resistant Bacterial Pathogens

1. Methicillin- Resistant S. aureus (MRSA)

a. These organisms are considered resistant to all penicillins, cephalosporins and macrolides.

b. Though MRSAstrains may be reported as susceptible to Fluoroquinolones, aminogycogides, chloramphenicol and

doxycycline in-vitro, these drugs are NOT to be used alone or as initial treatment for serious MRSA infections.

c. Rifampicin use should be avoided in diseases other than Mycobacterial diseases.

d. The drug of choice for treatment of infections due to MRSA is the glycopeptides i.e Vancomycin and Teicoplanin.

e. Linezolid can be used to treat skin and soft tissue infections caused by MRSA.

f. Mupirocin local application (intranasally bid x 5 days) for eradicating nasal carriage.

g. Daptomycin: Daptomycin is an intravenous antibiotic approved to be used for the treatment of complicated skin

infections and Staphylococcus aureus bacteraemia. Daptomycin should NOT be used for treatment of pneumonia due

to its inactivation by surfactant.

2. Vancomycin Resistant Enterococcus (VRE)

Enterococci are a therapeutic challenge because of their intrinsic resistance to many antibiotics. The acquisition of

resistance to vancomycin by enterococci has seriously affected the treatment and infection control of these organisms.

The treatment for VRE should be based on infection severity and in-vitro susceptibility of the strain to other antibiotics.

Linezolid: Linezolid is the only drug specifically approved for the treatment of VRE-blood stream

infections. Linezolid may be particularly useful in patients who require oral or outpatient therapy (when

intravenous therapy is undesirable), who are intolerant to glycopeptides, or who have impaired renal function.

Linezolid is a bacteriostatic agent; furthermore, linezolid toxicity when administered for prolonged courses may

limit its use in VRE endocarditis.

Ampicillin: Isolates that remain relatively susceptible to penicillin or ampicillin may be treated with high doses

of these agents.

Daptomycin: Not approved for treatment of VRE infection. Not approved for treatment of endocarditis.

Limited clinical information for VRE, but bactericidal activity makes consideration of this agent as sole therapy

in serious infections. However, emergence of resistance during therapy has been reported.

Doxycycline: Not a first line therapy. For susceptible isolates, not for bacteremia or endocarditis. It should not be

used as monotherapy.

Nitrofurantoin:Uncomplicated UTIs have been treated successfully with nitrofurantoin.

Fosfomycin: For urinary tract infections (cystitis) with isolates susceptible to fosfomycin.

Chloramphenicol: For chloramphenicol-susceptible isolates of E faecium and E. faecalis. Not a first-line therapy

and it should not be used as monotherapy.

Gentamicin or streptomycin: To be used in combination with ampicillin for the treatment of enterococcal

endocarditis caused by organisms susceptible in vitro to either agent; streptomycin is used when gentamicin

cannot be used because of resistance.

Tigecycline: Tigecycline has in vitro activity against a broad spectrum of Gram-positive and -negative bacteria,

anaerobes as well as multidrug-resistant pathogens such as MRSA and VRE. However, there is not much clinical

dataregarding its use for treatment of VRE infections.

3. Extended Spectrum Βeta-Lactamases (ESBL) Producing Enterobacteriaceae.

a. ESBLs are plasmid mediated β-lactamases that confer resistance to broad spectrum β- lactum antibiotics including

third and fourth generation cepahlosporins, azetronam, and extended spectrum penicillins. These plasmids often

encode mutations which confere resistance to other broad spectrum agents including aminoglycosides, co-trimoxazole

and fluoroquinolones, resulting in organism resistant to most broad spectrum antibiotics.

b. A major problem with ESBLs is their capacity to cause therapeutic failure with cephalosporins and azetreonam when

host organism appears to be susceptible to these agents in laboratory tests. Hence, CLSI recommends that

laboratories should report ESBL producing isolates as resistant to all penicillins, cephalosporins (including

cefepime and cefpirome), and azetreonam irrespective of in-vitro test results. c. The emergence of ESBL producing enterobacteriaceae is related to indiscriminate use of third generation

cephalosporins.

d. The carbapenems (Ertapenem, Meropenem and Imipenem) are currently considered the drug of choice for serious

infections caused by these pathogens. Piperacillin–Tazobactam and Cefoperazone- Sulbactam may be considered

options in mild infections and when ESBL producers are demonstrably susceptible in -vitro.

4. Carbapenem- Resistant Enterobacteriaceae (CRE)

a) Mechanism of resistance :


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i. Combinations of ESBL or AmpC and porin loss: Porin loss is often unstable and may impose afitness cost,

meaning that these strains rarely spread. Ertapenem is particularly affected.

ii. Acquired carbapenemases

b) Treatment :

i. Most carbapenemase producers are extremely drug resistant: being resistant to β-lactam antibiotics, aminogycosides,

and β-lactam–βlactam inhibitor combinations.

ii. Polymyxins, tigecycline & fosfomycin are the agents with most frequent in vitro activity, but all have limitations.

Dosage will vary with the patient and infection site, but should be on the principle of ‘highest safe’ rather than

‘minimum potentially effective; durations should be as standard for the infection type.

iii. Colistin - Case reports of successful use in a range of infections due to carbapenemase producers.

iv. Tigecycline:Active in-vitro vs. most carbapenem-resistant E. coli. Licensed for complicated skin and soft-tissue

Infections and complicated intraabdominal infections. Case reports of success in various infections with

carbapenemase producers. Low blood concentrations; off-label use should be cautious for blood stream infections,

unsuitable in urinary infections as only 22% excreted in urine. Excess deaths in some trials, especially ventilator

associated pneumonia (not a licensed indication).

v. Others: a few isolates are susceptible to other antibiotics including e.g. chloramphenicol, ciprofloxacin and

cotrimoxazole. Most producers, however, are resistant to these drugs.

Recommended measures to control spread of Multi-drug resistant organisms (MDRO) :

i. Improved laboratory detection and reporting of MDRO

ii. Enhanced infection surveillance and control in ICUs

iii. Prevent spread by barrier precautions : Gowns and gloves

iv. Hand Washing

v. Restricted use of 3rd

generation cephalosporins


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Chapter 4

Guidelines For Optimizing Use Of Key Antimicrobials

A. Antimicrobial Prescribing: Good Practice

1. Send for the appropriate investigations in all suspected infections as recommended. These are the minimum required for

diagnosis, prognosis and follow up of these infections.

2. All attempts shall be made to send microbiological samples prior to initiating antimicrobial therapy. Rapid tests, such as

Gram stain, can help determine therapeutic choices when decision on empiric therapy is required.

3. Differentiation between contamination, colonization and infection is important to prevent overuse of antimicrobials. Use

hospital guidelines based on local antibiograms when choosing antimicrobial therapy whenever possible. If alternatives to

those recommended as used, reasons in the case records should be documented.

4. Prescribing antibiotics just in case an infection is present is rarely justified. Where patients are in hospital close

observation is usually a better option till the diagnosis is made.

5. Choice of antibiotics: This depends on antibiotic susceptibility of the causative organism. There are some infections,

which can be treated by one of several drugs. The choice can be based on Toxicity, Efficacy, Rapidity of action,

Pharmacokinetics and Cost. Use the most effective, least toxic and least expensive antibiotic for the precise duration of

time needed to cure or prevent infection. Pathogens specific guidance in hospital policy is encouraged.Before

prescribing consider the following:

a. Which organism is likely to cause the disease?

b. What is the clinical diagnosis and what other steps should be taken to reach diagnostic precision?

c. Which antimicrobial agents are available and active against the presumed cause of the illness? Is their range of

antimicrobial activity appropriate and what information is available about the likelihood of drug resistance?

d. Check for factors, which will affect choice of drug and dose, e.g., renal function, interactions, allergy, pregnancy

and lactation.

e. Check that the appropriate dose is prescribed. If uncertain, contact Infectious Diseases Physician or clinical

microbiologist. Alternatively, check in the formulary.

f. What is the duration of treatment?

g. Is treatment working?

6. Clinical Diagnosis: The antibiotic treatment chosen must be based on presumptive diagnosis made on some assumption

regarding the nature of disease. The treating doctor may not have difficulty in choosing the appropriate antibiotic to treat a

disease caused by a single microorganisms e.g scarlet fever, typhoid, anthrax, as microbiological diagnosis is implicit in

clinical diagnosis. However, diseases such as pneumonia, meningitis and urinary tract infection can be caused by spectrum

of bacterial species and doctor may be wrong if he has to guess which antimicrobial agent to use. In such instances one

should seek a bacteriological diagnosis.

7. Empiric Therapy – If the causative agent is not known and where delay in initiating therapy would be life threatening or

risk serious morbidity, antimicrobial therapy based on a clinically defined infection is justified and the following points

should be taken into consideration :

a. Do not rush to treat.

b. Collect the necessary specimens before commencing therapy.

c. Cover all possible microbial causes.

d. Try to attain synergy.

e. Consider possible interaction with other drugs.

f. Accuracy of diagnosis should be reviewed regularly and treatment altered/stopped when microbiological results

become available.

g. Use less costly drugs where possible.

8. The need for antimicrobial therapy should be reviewed on a daily basis. For most infections 5 – 7 days of antimicrobial

therapy is sufficient (simple UTI can be adequately treated with 3 days of antibiotic).

9. All IV antibiotics may only be given for 48 – 72 hours without review and consideration of oral alternatives. New

microbiological or other information (e.g. fever defervescence for at least 24h, marked clinical improvement; low CRP)

should at this stage often permit a switch to oral antibiotic(s), or switch to an IV narrow spectrum alternative, or cessation

of antibiotics (no infection present).

10. Once culture reports are available, the physician should step down to the narrowest spectrum, most efficacious and most

cost effective option. If there is no step down availed, the reason shall be documented and is subjected to clinical audit.

11. Some guiding principles for de-escalation /Escalation:

a. If ESBL +ve: drug choice is monotherapy with carbepenems. Preferably choose group I carbepenem. Piperacillin

–Tazobactum and Cefoperazone –Sulbactam can be used if in-vitro sensitive and for mild infections.

b. Vancomycin should be used only for confirmed MRSA infections and not in MSSA infections.

c. In case of Pan drug resistant Pseudomonas /Acinetobacter spp. combination therapy using colistin along with

beta-lactams (using PK/PD principles) should be discussed with microbiologist / physician.

12. . Treatment with antibiotic combinations: In order to avoid antagonism between drugs and undesirable side effects of

several antibiotics it is advisable to use a single drug where ever possible. There are situations however, when the use of

antibiotic combination is desirable. The situations are:


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a. A temporary expedient during the investigation of an obscure illness.

b. To prevent the development of bacterial resistance in long term therapy e.g treatment of tuberculosis.

c. To achieve synergistic effect, e.g. in treating infective endocarditis.

d. Mixed infection, when one drug is not effective against the pathogen.

e. To permit a reduction of the dose of potentially toxic drug.

The choice of the drug should be that they act synergistically. The following combinations are synergistic

1. Aminoglycoside and beta–lactam antibiotic.

2. Beta –lactam antibiotic and beta–lactamase inhibitor.

3. Beta –lactam antibiotic and Glycopeptide (vancomycin/teicoplanin)

4. Sulphamethoxazole and Trimethoprim.

14. Is Treatment working?: Where treatment is apparently failing, advice from an ID physician/clinical microbiologist

should normally be sought rather than blindly changing to an alternative choice of antimicrobial agent.

Antimicrobial drug therapy cannot be considered in isolation and other aspects of therapy must be taken into account in

judging the effect of treatment. Even an appropriate antibiotic may be ineffective unless pus is drained, septic shock

treated and hypoxia and anemia corrected. There are several conditions in which chemotherapy alone cannot eliminate an

infection. Obstructive lesions can cause infection to recur, unless they can be dealt with surgically. Also, chemotherapy

cannot obviate the necessity for draining an abscess or removing sequestra or calculi. Failure of treatment can also be due

to a super-added infection, e.g. phlebitis, development of resistance during therapy or poor tissue penetration.

13. Laboratory control of the effects of treatment: Whether treatment has been successful or not is best judged by clinical

criteria, but it is useful to know whether the infecting organism has been eliminated. Reapeated cultures are, therefore

sometimes indicated.

B. Reserve Antimicrobials

These reserve antimicrobials will be made available following a recommendation from the Microbiology Department as per

culture report or if included in an antimicrobial policy for a clinical specialty that has been agreed with antibiotic management

team. They are held in reserve to maintain their effectiveness in treating certain difficult infections by reducing the spread of

microbial resistance and to encourage cost effective prescribing. Before a reserve antibiotic is issued to the ward, the

pharmacist is instructed to ascertain the indication and if this falls outside the approved policy, to request that the prescriber

consult the ID Physician/clinical microbiologist.

The following criteria has been proposed to protect the Carbapenems and Linezolid from overuse –

1. Severe sepsis as defined by more than one organ failure of new onset and/or elevated serum lactate.

2. Clinical failure of other classes of antibiotics over 48 hours in terms of worsening inflammatory markers, unresolving

fever and new/worsening hemodynamic instability.

3. Underlying severe immuno-suppression – Neutropeniea, immuno-suppressive therapy, Diabetic Ketoacidosis (DKA)

etc.

4. The organism is susceptible to only carbapenems / linezolid, as per culture report.

The following criteria has been proposed for initiating Colistin –

1. Pan-resistant organism as per culture report with evidence of invasive disease – fever/ leucocytosis/elevated

procalcitonin (PCT) or culture from a sterile site.

2. Clinical failure of all other classes of antibiotics over 72 hours.

The following criteria has been proposed for initiating Rifampicin –

1. Empiric or proven TB as a part of ATT (4 drug regimen)

Rifampicin should not be prescribed in our country for any treatment other than for Mycobacteria and for

chemoprophylaxis of meningoccal meningitis in clinically indicated population

Rifampicin should not be prescribed alone as an anti-bacterial.

The following criteria has been proposed for initiating Aminoglycosides –

I. The focus of infection is not lung or an anaerobic abscess.

II. Only as a part of initial empiric regimen of a combination therapy – shall step down to single drug after culture report.

III. Other safer drug options have been ruled out in a culture report.

C. Hypersensitivity

All patients should be asked about drug allergies. This is the responsibility of the doctor caring the patient. If a patient reports a

drug allergy clarify whether this is an allergy or drug intolerance. In some cases there will be an overlap between drug allergy

and drug intolerance.

Clinical features suggestive of drug allergy:

One or more symptoms developed during or following drug administration including difficulty breathing, swelling,

itching, rash, and anaphylaxis, swelling of the lips, loss of consciousness, seizures or congestion involving mucous

membranes of eyes, nose and mouth.


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Clinical features suggestive of drug intolerance:

One or more symptoms developed during or following drug administration including gastrointestinal symptoms e.g.

nausea, vomiting, diarrhoea, abdominal pain and feeling faint.

If patients are unable to give an allergy history, the doctor caring in the patient should take reasonable steps to contact

someone who can provide a reliable allergy history. It is the prime responsibility of the prescribing doctor to ensure that:

i. The allergy box on the patient’s drug chart is completed, when a new prescription chart is written or transcribed. If

no allergy - specify "No known allergy". The box should be signed and dated. If allergy history cannot be obtained,

then specify "history not available." Under no circumstances should the allergy box be left blank. A pharmacist or

nurse may complete the allergy box if the allergy status is documented in the clerking in notes.

ii. The allergy box is completed before prescribing a new drug, except in exceptional circumstances. If patients have a

suspected drug allergy then the drug and suspected reaction. Should be documented in the clerking-in notes and the

drug chart.

D. Alert Antimicrobials

To Prevent and Control the Emergence and Spread of Antimicrobial-Resistant Micro-organisms in Hospitals” one major

strategic goal is to “define guidelines for use of key antibiotics”, (“Alert” antibiotics) targeted in these guidelines are

ciprofloxacin, ceftazidime, cefotaxime, ceftriaxone, vancomycin (or teicoplanin), imipenem, levofloxacin, meropenem,

moxifloxacin,piperacillin-tazobactam, linezolid (oral/IV), voriconazole, caspofungin, valganciclovir, ertapenem and

newer preparations of amphotericin.

Collectively, these are among the drugs most frequently prescribed irrationally which is largely responsible for the current

escalation of antibiotic costs. They also account for a significant proportion of serious antibiotic toxicity including Clostridium

difficilediarrhoea and CNS toxicity/seizures as well as the emergence of major antimicrobial resistance. Safer, cheaper and

equally effective alternatives are often available which allow such agents to be kept in reserve for occasions when there are

clear cut microbiological indications. It is critical, therefore, that these Alert antibiotics be prescribed only on the

recommendation of senior medical staff or after discussion with the on-call Clinical Microbiologist or ID physician.

E. Alert Antibiotics And Their Indications

1. CIPROFLOXACIN, INTRAVENOUS

Oral ciprofloxacin is well absorbed and this is therefore the preferred route of administration. Intravenous therapy is only

indicated in the following situations:

When the patient is unable to swallow or the oral route is otherwise compromised.

In serious sepsis (e.g. nosocomial pneumonia in ITU) when the recommended dose is 400mg 8 hourly.

Common indications for ciprofloxacin in the Antibiotic Policy, either alone or in combination, are as follows:

second line therapy in exacerbation of chronic bronchitis

pyelonephritis

acute inflammatory infective diarrhoeas

serious infected diabetic ulcers infected burn wounds with coliforms or Pseudomonas infection present

treatment of documented or presumed gram-ve bacilli resistant to penicillins or cephalosporins or when the patient is

allergic (history of anaphylactic reaction or rash) to these agents

selected haematology patients requiring prophylaxis

severe acute pelvic inflammatory disease

2. CEFTAZIDIME

Limited use only. Main indication is documented or suspected Pseudomonas aeruginosainfection. Other indications currently

listed in the Antibiotic Policy are as follows:

Second line agent in neutropenic patients with septicaemia or pneumonia

Empiric therapy of CAPD associated peritonitis (not children), 1g IV stat then 125mg/litre in each bag

Empiric therapy of post operative, post traumatic or shunt associated meningitis

Empiric therapy of infective exacerbation of cystic fibrosis

3. PIPERACILLIN - TAZOBACTAM

Currently listed in the antibiotic policy for the following:

Pneumonia or septicaemia in neutropenic patients (+ Gentamicin)

As a single agent (or in combination with Gentamicin) for treatment of sepsis which has not responded to first line

treatment or if it is not appropriate for gentamicin to be added to first-line therapy.

4. CEFTRIAXONE

IV Ceftriaxone is currently listed in the antibiotic policy for the following:

Epiglottitis,

Brain abscess,


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Bacterial meningitis,

Pyelonephritis in children,

Empiric therapy of septicaemia in children,

In ascites for treatment of sub-acute bacterial peritonitis,

Skin and soft tissue infections managed via out-patients or the home IV antibiotic programme,

Acute septic monoarthritis if penicillin allergic,

Spontaneous bacterial peritonitis.

5. APPROPRIATE USE OF CARBEPENEMS

Very high rates (60-75%) of resistance to 3rd

and 4th

generation cephalosporins {due to extended spectrum beta-

lactamases (ESBL) production} observed in E. coli and Klebsiella species..

This pattern of resistance although seen primarily among nosocomially acquired infections, is also seen isolates of E

coli and Klebsiella species isolated from community acquired infections.

These strains of bacteria are frequently resistant to other major classes of antibiotics (fluoroquinolones, β-lactam + β-

lactamase inhibitor(BL + BLI) combinations and aminoglycosides)

Carbapenems (imipenem, meropenem and ertapenem), beta-lactam antibiotics with exceptionally broad spectrum of

activity, are the only class of antimicrobials which remain effective against ESBL-producing isolates of E coli and

Klebsiella species

Imipenem is susceptible to degradation by the enzyme dehydropeptidase-1 (DHP-1) located in renal tubules and

requires coadministrationwith a DHP-1 inhibitor cilastatin. Meropenem and ertapenem are administered without a

DHP-1 inhibitor.

Indications for carbapenem use:

1. Infections [e.g., bacteremia, pyelonephritis, intra-abdominal infections (peritonitis, cholangitis, abscesses), nosocomial

pneumonia etc.] confirmed (by appropriate culture and susceptibility studies) to be caused by Gram-negative bacteria (E

coli, Klebsiella spp., Enterobacter spp., Pseudomonas aeruginosa, other non-fermenting Gram-negative bacilli) resistant

to other classes of antimicrobials and susceptible only to carbapenemsin-vitro

2. Initial empiric treatment for severe, life-threatening infections (associated with multi-organ dysfunction, septic shock)

caused by Gram-negative bacteria.

Febrile neutropenia

Ventilator associated / nosocomial pneumonia

Pyelonephritis / complicated urinary tract infections

Complicated intra-abdominal infections

Once the culture and susceptibility reports are available, choose the most appropriate antibiotic based on spectrum of

activity, toxicity and cost (‘de-escalation’).

Indications for Ertapenem use:

Ertapenem has excellent in-vitro and in-vivo activity against ESBL producing Enterobacteriaceae, but lacks activity against

Pseudomonas aeruginosa, and is therefore not considered appropriate for the treatment of conditions like febrile neutropenia

and serious nosocomial infections. Ertapenem does not select Carbapenem-resistant Pseudomonas aeruginosa (at least in the

short-term). Its use should be restricted to severe Gram-negative or polymicrobial community acquired infections confirmed to

be caused by susceptible bacterial pathogens. Hence, this drug may be recommended as the initial choice for ESBL producing

strains of E coli and Klebsiella spp..

Indication of Meropenem and Imipenem

Meropenem and Imipenem regarded as third line agents and are reserved for:

serious infections due to multiple resistant strains (e.g. ESBL)

empiric use in the seriously ill patient in either ITU or Haematology

the treatment of infective exacerbations in Cystic fibrosis (CF)

severe acute narcotising pancreatitis

Outside these clinical settings it should only be used after consultation with a Clinical Microbiologist or ID physician.

Unlike imipenem , meropenem has not been associated with CNS toxicity. Also, it is administered by convenient IV bolus

injection. Clinicians must be aware that mechanism of resistance to meropenem and imipenem are different and hence in-vitro

test for one carbapenem cannot be used to interpret the other.

Dose

Imipenem*: 500 mg i.v. Q6H

Meropenem: 1 gmi.v.Q8H

Ertapenem: 1gm i.v. /i.m.Q 24H

*Note Anti-infective sub-committeerecommends use at a more frequent dosing interval. They believe that optimum

plasma concentrations are more reliably maintained with 6-hourly dosing.


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6. LINEZOLID (IV AND ORAL FORMS)

Linezolid should only be prescribed after consulting an ID specialist or clinical microbiologist and a mandatory order

form completed.

Restricted indications including infections due to proven glycopeptide-insensitive Staphylococcus aureus or

vancomycin-resistant enterococcus (currently uncommon).

To enable IV/oral switch from IV vancomycin (used for MRSA or MRSE) to oral linezolid (when patient’s discharge

is possible and continuation treatment using combination rifampicin /trimethoprim is inappropriate.

May be an option in surgical site infections (e.g. large bowel surgery, vascular surgery, etc).

Poor IV access and a glycopeptide is indicated.

Use in out-patient home parenteral antibiotic therapy for skin and soft tissue infections as an alternative to IV

teicoplanin.

Rare cases of proven hypersensitivity/allergy to the glycopeptides.

7. VANCOMYCIN

Vancomycin is the drug of choice for in-patient treatment of the following infections.

Serious (e.g. bacteraemia, osteomyelitis) coagulase negative staphylococcal and MRSA infections and penicillin

resistant enterococcal infections

Empiric therapy in febrile neutropenic patients not responding to first line therapy

Continuous ambulatory peritoneal dialysis (CAPD) associated peritonitis

Prosthetic valve endocarditis

8. TEICOPLANIN

Teicoplanin is a suitable alternative to vancomycin for all indications for Vancomycin except meningitis:

patients receiving out-patient/home parenteral therapy with glycopeptidesafter loading dosages

inability to tolerate vancomycin

oncology/haematology patients

Rare cases of vancomycin resistant and teicoplanin sensitive strains.


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Chapter 5

Preventive Strategies for Healthcare Associated Infections

A. Healthcare Associated Infections

Health Care Associated Infections or HCAI are a worldwide phenomenon. HCAI have been defined variously at different

times and by different organizations. Current definitions incorporate infections which were neither incubating nor did they

manifest or present, during the period of admission in patients admitted in the hospital but were present on or after the 3rd

calendar day of admission, (the day of hospital admission being calendar day 1).

B. Reducing the risk of Health care associated infections

B1. Development of an effective Infection Prevention and Control Program

Infection Prevention and Control Programs are directed towards patient safety and health care professionals’ safety. Reducing

the preventable part of health care associated infections (HCAI) is central to any Infection Control program.

An effective Infection Prevention and Control Program would have the following components:

1. Infection Control Committee with its defined role and constituents

2. Infection Control Core Team for day to day working with defined roles

3. Infection Control Manual with policies, guidelines, recommendations and working protocols including activities and

practices under the program with Hand hygiene and Standard Precautions being the mainstay

4. Annual Plan for each healthcare setup with prioritization based on risk matrix for that unit and review

5. Should incorporate Antimicrobial Stewardship programs

B2. Hand-hygieneand Standard Precautions’

Health care workers and professionals anywhere and at all levels should be well oriented to concepts of hand hygiene.

Practicing ‘Standard Precautions’, prevents direct contact with all body fluids (including blood), secretions, excretions, non-

intact skin (including rashes), and mucous membranes.

Hand hygiene in the form of tap, sink and appropriate antiseptic/ rubs for washing or hand-rub or surgical scrub should be

facilitated. Atleast hand rubs should be available in all patient care areas including patient’s bed side or easily available within

vicinity.

Indications for hand washing and hand antisepsis should be made known amongst all engaged in providing patient care.

Protocols and procedures of any area should always include hand hygiene as applicable and these should be mandatory step.

B3. Antimicrobial Stewardship Program

Antimicrobial Stewardship Program shall form another main focus of the Infection Prevention and Control Program. This shall

include all components of antimicrobial stewardship so as to stress upon advocacy of safe use of antimicrobials, which shall be

strengthened, with periodic review of antimicrobial guidelines and implementation locally in each of the health care setups.

B4. Educational Programs and Strategies

Appropriate educational material should be made available to all. These shall be based upon recent evidences and part of

relevant national and international guidelines and appropriately indigenized for effective implementation. This would be

augmented by periodic CME or educational interactive programs and awareness drives. Local Health care setup should provide

antimicrobial susceptibility patterns, appropriate usage of antimicrobials and have updates on antimicrobials communicated to

all relevant personnel in patient care, locally and periodically. Specific infectious diseases and their prevention and control

awareness should be made available as and when required to relevant staff locally and may be extended to community if so

desired by the health departments of that district/city/area.

B5. NotificationAll relevant information as required by law on communicable diseases would be notified as appropriate to

relevant authority. Incase of specific reports from public health agencies requiring action on their recommendations,

appropriate action should be taken.

B6. Prophylaxis including Immunization

Staff should be immunized against diseases, which have risk of transmission through exposure from patients and to limit

transmission of diseases from healthcare workers to patients. Immunisation in high-risk group may be required for influenza,

meningococcal infections among exposure prone healthcare workers in outbreak situations, hepatitis B vaccination for all staff,

varicella vaccine to high-risk group etc. Among the diseases that have potential of being transmitted from healthcare workers

to patients typhoid vaccine should be included among the food handling staff. Immunise all health care workers and others

involved in handling of bio-medical waste for protection against diseases including Hepatitis B and Tetanus that are likely to

be transmitted by handling of bio-medical waste. All the under trainee staff including medical and nursing students should be

immunized for potential occupational risk exposures (e.g. hepatitis B vaccination to the students).


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Chapter 6

Monitoring Antimicrobial Use

A. Background

World Health Organization’s 2014 report on global surveillance of antimicrobial resistance reveals that antibiotic

resistance is no longer a prediction for the future; it is happening right now, across the world, and is putting at risk the

ability to treat common infections in the community and hospitals. It is an increasingly serious threat to global public

health that requires action across all government sectors and society.

There are high proportions of antimicrobial resistance (AMR) amongst bacteria that cause common infections (e.g. urinary

tract infections, pneumonia, bloodstream infections) throughout the world. Resistant microorganisms (including bacteria,

fungi, viruses and parasites) are able to survive attack by antimicrobial drugs, such as antibacterial drugs (e.g., antibiotics),

antifungals, antivirals, and antimalarials, so that standard treatments become ineffective and infections persist, increasing

the risk of spread to others.

The evolution of resistant strains is a natural phenomenon the use and misuse of antimicrobial drugs accelerates the

emergence of drug-resistant strains. The evolving public health threat of AMR is driven by both appropriate and

inappropriate use of antimicrobial agents. Overuse plays an important role in the emergence of AMR. Paradoxically,

underuse through inappropriate choice, inadequate dosing, poor adherence to treatment, and substandard antimicrobials,

also plays an important role in the emergence and spread of AMR. Hence, there is need to monitor the use of

antimicrobials at all levels of health care, study the antimicrobial use practices in various infections and behavior of

stakeholders for antibiotic use and resistance.

B. Need For Surveillance To Track Antimicrobial Use And Resistance

Increasing levels of antimicrobial resistance correlate with inappropriate antibiotic use as shown at the population and

individual level. Therefore, our goal should be to use antimicrobials rationally and for that we need to know how

antimicrobials are being used. Monitoring of antimicrobial use is a crucial component to identify targets for improving

antimicrobial use and to further correlate with antimicrobial resistance surveillance programmes. World Health Organization

(WHO) highlights the establishment of effective, epidemiologically sound surveillance of antimicrobial use and AMR among

common pathogens in the community, hospitals and other health-care facilities as one of the key public health priorities.

Surveillance systems are required to understand trends in antibiotic use and AMR, as well as the long-term temporal

associations between these two in different areas. Tracking antimicrobial use, and the emergence and spread of resistant strains

of bacteria provides information, insights, and tools needed to guide policy and to evaluate measures taken to promote

appropriate antimicrobial use at all levels, from local to global. Data could also stimulate a sense of urgency to act. Improving

antibiotic use is the key feature in efforts to contain AMR. Strategies for interventions to reduce antibiotic use have to be

prioritized and customized based on local realties. Data from surveillance could help in identifying priorities and processes and

in documenting a baseline for monitoring effects of interventions.

C. Standardized Methodology And Outcome Measures

The use of a standardised methodology allows meaningful comparisons over time and between different facilities or countries.

Expression of antibiotic consumption should be in international accepted formats. Therefore, we need to have a methodology

and a common unit of measurement in each country in order to assure the comparability of the data.

The Anatomical Therapeutic Chemical (ATC) classification and the Defined daily Dose (DDD) as a measuring unit have

become the gold standard for international drug utilization research. ATC/DDD methodology of classification is a tool for

drug utilization research in order to improve quality of drug use. It is an international language for grouping of drugs and

measuring consumption of drug use. The WHO recommends this methodology of classification as their international standard

for drug utilization studies. This methodology is widely used in drug catalogues, drug safety assessment and drug utilization

and pharmacoepidemiology. The ATC/DDD system is a tool for exchanging and comparing data on drug use at international,

national or local levels. When monitoring antimicrobial consumption in pediatric setting, tota antibiotic events

C1. The ATC Classification

The ATC system was initiated in the 1970s by the Norwegian Medicinal Depot, and is now coordinated by the World health

Organization (WHO) Collaborating Centre for Drug Statistics methodology, established in Oslo in 1982. The centre revises the

ATC codes as necessary and maintains an online database and published index. Drugs are divided into different groups

according to the organ or system on which they act and/or their therapeutic and chemical characteristics. Each drug is assigned

at least one ATC code, which are classified into groups at five different levels. Table 1 below shows an illustration using

amoxicillin as an example.

Table1: Classification of amoxicillin of the Anatomical Therapeutic Chemical (ATC) classification system

ATC

Classification

ATC Category Description

J General anti-infectives for systemic use 1st level, anatomical main group


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J01 Antibacterials for systemic use 2nd

level, therapeutic main group

J01C Beta-lactam antibacterials, penicillins 3rd

level, therapeutic/pharmacological subgroup

J01C A Penicillins with extended spectrum 4th

level,chemical/therapeutic/pharmacological subgroup

J01C A04 Amoxicillin 5th

level, subgroup for chemical substance

C2. Defined Daily Dose

To facilitate the ability to compare consumption information across time and geography, a technical unit of measurement was

created for use in conjunction with the ATC classification. It is referred as the Defined Daily Dose (DDD) and assigned to

each drug at the 5th

level (chemical substance) classification. It is defined by the ATC as the assumed average maintenance

dose per day for a drug used for its main indication in adults. For antibiotics, the main indication is moderate to severe

infections. The WHO Collaborating Centre using established principles assigns ATC and DDDs. Different DDDs may be

assigned for different drug formulation (ie, parenteral versus oral). Table 2 provides some examples of DDDs for antibiotics.

Table 2: Examples of Defined Daily Doses

ATC Classification ATC Drugs Defined Daily Dose

J01C A04 Amoxicillin 1 g (oral or parenteral)

J01M A06 Norfloxacin 0.8 g (oral)

J01M A02 Ciprofloxacin 1 g (oral)

0.5 g (parenteral)

J01F F01 Clindamycin 1.2 g(oral)

1.8 g (parenteral)

J01C A12 Piperacillin 1.4 g (parenteral)

ATC – Anatomical Therapeutic Chemical

DDDs are useful for measuring and comparing volumes of drug use. DDDs should not be considered as the “correct” dose but

as an international compromise on review of available documentation.

C3. How to use the ATC/DDD classification to quantify the antibiotic consumption?

1. For OPD from administrative prescription claims data, If data are available at the individual claim level and the

antibiotic is identified or mentioned, it is a fairly straightforward process to apply the ATC classification and convert

into a number of DDDs. For example, if the prescription indicates that the particular patient was dispensed 14

ciprofloxacin 500 tablets from a particular pharmacy. The number of DDDs is calculated by multiplying the quantity

by the DDD conversion factor. In this example, the strength of one tablet is 500 mg and the ATC/DDD is 1 g for

ciprofloxacin. Each 500 mg tablet is equivalent to 0.5 DDD. Multiplication of the quantity dispensed (14 tablets) by a

conversion factor of 0.5 equals to total of 7 DDDs dispensed from this prescription. Data can then be collated,

expressed and evaluated based on any other prescriptions record and then merged.

2. Hospital pharmacy data: Most hospital pharmacies have the ability to express their drug dispensing information in

monthly collation of numbers of drugs dispenses by type of drug. ATC/DDD system can be applied in a similar

fashion to the above out-patient prescription example. The usual divisions within a hospital are wards or various

departments. Consumption data can be collated for each department separately from the pharmacy records.

C4. Expressing consumption information

Most commonly, units for antibiotic consumption include DDD per 1000 inhabitant-days for out-patient data and DDD per

100 bed-days in hospitals.

Because the ATC/DDD system is continuously being modified, it is essential that the version (year) of ATC classification in

use is clearly identified. The most recent classification is usually used. However, one must be aware of changes in the

classification or DDD assignment when comparing with earlier information.

D. Situation In Developing Countries

There are wide variations between regions and countries, in their capacity to carry out surveillance system. In resource-poor

countries with comparatively weak health systems, there are constraints related to infrastructure, trained personnel, networking

and coordination. Currently it is not possible in resource-poor countries to quantify the effects of AMR on the individual or the

community, because of lack of availability of good quality data in sufficient quantities. Therefore, developing validated,

reproducible and sustainable surveillance methodologies to quantify AMR and antibiotic use in the community, and to inform

the development of interventions and evaluate their impact is a priority.

The methods for obtaining data are often problematic, especially with regards to data on antimicrobial use. About 80% of

antibiotics are used in the community and the rest are used in hospitals. There is a lack of community-based databases on

AMR and antibiotic use in developing countries. Moreover, antibiotics can be obtained easily from private retail pharmacies

without prescription and pharmacists also advise and dispense antibiotics to patients. Therefore, developing a methodology,

which is reproducible and sustainable, is needed to measure antimicrobial use in the community for developing country.


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High-end Antibiotic Monitoring Sheet

Surgical Prophylaxis Monitoring Sheet


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Chapter 7

Dosage Guide For Commonly Used Antimicrobial Agents

ANTIBIOTICS ADVERSE REACTION ROUTE PAEDIATRIC

DOSE

ADULT DOSE

Amikacin Nephrotoxicity, Ototoxicity Intravenous 15-22.5 mg/Kg/day

in 2-3 doses

15mg/Kg/day q 8-12

hours, max doses

1.5mg/Kg

Amoxycillin Fever, rash, diarrhea, abdominal cramps,

AST ALT elevation.

Oral 20-50mg/Kg/day, 3-4

doses

250-500mg q 8 hourly

Amoxycillin-

clavunate

(co-amoxyclav)

Rash, diarrhea, abdominal, AST ALT

elevation

Oral,

Intravenous

40mg/kg/day

(amoxicillin) in 2

doses

90mg/kg/day if

penicillin resistant S.

pneumoniaesuspected

in otitis media

100mg/kg/day

375mg 8hourly

625-1000mg 12 hourly

Ampicillin Hypersensitivity reaction, nausea,

diarrhea, exfoliative dermatitis, seizures,

precipitates infectious mononucleosis

rash, interstitial nephritis.

Intravenous

or

Oral

100-400 mg/kg/day

in 4 doses (IV)

500 mg-1gm q 6 hourly

Azithromycin Leukopenia, transient elevation of liver

enzymes, renal toxicity.

Oral 10 mg/kg/day once

daily

Enteric fever 20

mg/kg/day once daily

500mg daily

Azetronam Rash, Diarrhoea , vomiting, AST, ALT

elevation

Intravenous 30 - 120mg/kg/day

Q 6-8 hourly

In cystic fibrosis max

dose 200 mg/kg/day

1-2g q 8 hourly, Max

dose 8gm in 24 hours

Benzathine

penicillin

Hypersensitivity and Jarisch Herxheimer

reaction, haemolytic anemia, seizures

with high doses in renal failure

Intramuscular 1,200,000 units( >30

Kg)

600,000 units ( <30

Kg)

1.2-2.4 million

units/dose

Cefadroxil Rash eosinophilla Oral 30 mg/kg/day in 2

doses

500mg bid or 1 g bid

Cefazolin Leukopenia, eosinophilia, rash, transient

elevation of liver enzymes renal toxicity

Intravenous 100 mg/kg/day 3-4

divided doses

0.52gm q 6-8 hourly

Cefepime Same as third generation cephalosporins.

Adjust dose in renal failure.

Intravenous 1-4gm/day 2-3 doses

Cefixime Diarrhoea, Leukopenia, renal toxicity,

transient elevation of liver enzymes.

Oral 15mg/kg/day in 2

divided doses,

20mg/kg/day in 2

divided doses for

enteric fever.

400mg/day in 1-2

divided doses.

Cefotaxime Arrythmia, transient elevation of liver


Intravenous 100mg/kg/day in 3-4

divided doses,

200mg/kg/day in 4

divided doses for

meningitis

1-2gm 6-8 hourly

Ceftazidime Hypersensitivity reaction, dizziness, rash,

diarrhea, colitis, exfoliative dermatitis,

thrombocytopenia

Intravenous

Intramuscular

75-100mg/kg/day in

3 divided doses

100mg/kg/day in

meningitis (IV)

1-2g q 8-12 hourly (IV)

Ceftriaxone Gall bladder sludging , transient elevation

of liver enzymes, renal toxicity

Intravenous 50-100 mg/kg/day in

2 divided doses

Meningitis

100mg/kg/day in 2

divided doses

1-2gm q 12-24 hourly

Cefuroxime Leukopenia, eosinophilia, allergic

reaction, transient elevation of liver

enzymes , renal toxicity

Intravenous 75-100mg/kg/day in

3 divided doses

750mg- 1.5g q 8 hourly


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DOSE

ADULT DOSE

Cefuroxime Leukopenia, eosinophilia, allergic

reaction, transient elevation of liver

enzymes , renal toxicity

Oral 20-30mg/kg/day in 2

divided doses

250-500md bid

Cephalexin Transient neutropenia, AST and ALT

elevation, arthralgia, rash, eosinophilia.


divided doses


Chloramphenicol Bone marrow suppression, aplastic

anaemia, grey baby syndrome, hemolysis

in G6PD deficiency

Oral

Intravenous

75-100mg/kg/day in

4 divided doses

Avoid in infants less

than 3 months

50mg/kg/day in 4

divided doses

Ciprofloxacin Nausea, vomiting, abdominal discomfort,

arthralgia, photosensitivity transient

elevation of liver enzymes

Oral

Intravenous

20-30mg/kg/day in 2

divided doses


Clarithromycin Transient elevation of liver enzymes,

renal toxicity, nausea, abdominal cramps

Intravenous

Oral

15mg/kg/day in 2

divided doses

250-500mg bid

Clindamycin Diarrhea, nausea, pseudomembranous

colitis, skin rash, Erythema multiforme ,

raised ALT AST, thrombocytopenia,

leucopenia

Oral

Intravenous

40-60mg/kg/day in 3-

4 divided doses

150-300 mg q 6-8

hourly (oral, iv)

Severe infections 300-

600 mg 8 hourly IV

Cloxacillin Dose related neutropenia, elevated AST,

ALT, Cholecystitis interstitial nephritis.

Oral

Intravenous

50-100mg/kg/day in

3-4 divided doses.

100-200mg/kg/day

divides q 6 hourly

250-500mg/kg/day in

3-4 divided doses

1-2 gram q 6 hourly

Cotrimoxazole Megaloblastic anaemia, distrurbance,

rash, erythema mutliforme major/minor


divided doses (5-0

mg trimethoprim)

20mg/kg/day in 4

divided doses in

Pneumocystis

jirovecii pneumonia

160mg (Trimethoprim)

bid

Ertapenem Diarrhoea, nausea, vomiting, headache,

hallucination, seizures, arrhythmia,

pseudomembranous colitis, dose

reduction in renal failure

Intravenous

Intramuscular

3-12 years:

15mg/kg/day twice

daily. (not to exceed

1gm/day)

13 years and above

1gm IV infusion/ IM

once daily in 3-5 ml of

lidocain

CI if hypersensitivity

to lidocaine/β lactam

Erythromycin Arrhythmia Jaundice Oral 40on 4 divided doses 250-500mg q 6 hourly

Furazolidine Avoid alcohol, tyramine containing food,

Mao inhibitors, Nausea headache,

dizziness, fall in BP, urticarial, safety in

pregnancy unknown

Oral 100mg 3-4 times a

day 5mg/kg in 3-4

divides doses (not

below one year)

100mg 3-4 times a day

Gentamicin Nephrotoxicity ototoxicity and optic

neuritis

Intravenous

Intramuscular

5-7.5 mg/kg/day in 2-

3 divided doses

1.3-6 mg/kg/day in 3

divided doses

Imipenemcilastin Nausea, diarrhea, rash Oral Intravenous 500mg once daily

Linezolid Peripheral and optic neuropathy,

thrombocytopenia, hypertension,

myelosuppression, colitis.

Oral

Intravenous

10mg/kg/dose 6-8

hourly (oral, IV)

400-600 mg q 12

hourly

Meropenem Hypotension, transient elevation of liver

enzymes, renal modification in renal

failure

Intravenous

Oral

7.5 mg/kg/day/dose

(IV) divided doses in

meningitis

1.5-3gm/day in 3

divided doses 6gm/day

in meningitis

Metronidazole Nausea, metallic taste, disulfuran like

reaction with alcohol, peripheral

neuropathy

Intravenous

Oral

7.5 mg/kg/day dose 3

times/day

30-50mg/kg/day in 3

divided doses for

liver abscess

500-700 q 8 hourly

Nalidixic acid Hepatotoxicity, myalgia, leukopenia,

vertigo, rash, dizziness, pseudotumor

cerebri, seizure, avoid in G6PD deficiency

Oral 8 mg/kg/day in 2

divided doses

1gm 4 times/day


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DOSE

ADULT DOSE

Nitofurantoin Discoloration of urine, vertigo, rash,

methemoglobinemia, cholestatic jaundice,

hepatocellular damage and neuropathy.

Avoid at term and labour.

Oral 8 mg/kg/day in 2

divided doses

50-100 mg q 6 hourly

(5-7mg/kg/day in 4

divided doses max dose

400mg)

Norfloxacin Sam as quinolones Oral 20-30 mg/kg/day in 2

divided doses

200-400 mg twice daily

Ofloxacin Leukopenia, transient of liver enzymes,

renal toxicity. May precipitate

psychosis/seizures,photosensitivity.

Oral

Intravenous

20 mg/kg/day in 2

divided doses

200-400 q 12 hourly

Penicillin G Hypersensitivity reaction like anaphylaxis

rare. nonfatal reactions are like serum

sickness, rash contact dermatitis seen in 1

in 1000 adults. Jarisch Herxheimer

reaction, haemolytic anaemia with high

doses

Oral

Intravenous

50,000units/kg/

dose 6 hourly (Oral)

200,000-400,000

units/kg/day in 4

divided doses (IV)

2-24 million units day

in divided doses q 4-6

hours (IV)

Penicillin V Rash, haemolytic anaemia interstitial

nephritis, seizure with high doses.

Oral 20-50 mg/kg/day in 4

divided doses

250-500 mg every 6-8

hourly.

Piperacillin –

Tazobactum

Leukopenia, transient elevation of liver


Intravenous 200-400mg/kg/day in

3-4 divided doses

4.5 gm q 8hourly

Teicoplanin Hypersensitivity reactions, rash, less

nephrotoxic as compares to Vancomycin

Intravenous

Intramuscular

10mg/kg/day /dose

every 12 hours for 3

doses the

10mg/kg/day once

daily

400mg once daily (6-

30mg/kg/day)

Tigecycline Nausea, vomiting, allergic reactions,

photosensitivity, pseudo tumor cerebri,

pancreatitis.

No dose adjustment to renal failure

Intravenous Above 10 years 100mg followed by

50mg every 12 hurly

infusion over 30-60

minutes.

Vancomycin Red man syndrome, oto-toxicity,

nephrotoxicity

Intravenous 40-60 mg/kg/day in

3-4 divided doses

0.5gm q 6 hourly or

1gm q 12 hourly

.

Drug doses in Pediatric Age group

Drug name Dose Frequency Maximum

dose

Comments

Cefepime

Infants >14 days of age and Children >40

kg in weight

50 mg/kg q 12 h

Ceftazidime

Infants and children <12 years

100–15

mg/kg/d

Divided q 8 h 6 g

Cefotaxime

Infants and children

a) < 50 kg

b) >12 years and >50 kg

100–200

mg/kg/d

1–2 g

Divided q6-8 h

q 8 h

2 g

Ceftriaxone


50-75 mg/kg/d Divided q 12 h 2 g

Vancomycin


40 mg/kg/d Divided q 6-8

h

2 g

Linezolid

Infants and children <12 years

Children >12 years of age and adolescents

10 mg/kg

10 mg/kg

q 8 h

q 12 h

Piperacillin 100-300

mg/kg/d

q 8 h 4 g

Ciprofloxacin 20–30 mg/kg/d divided every

12 h

800 mg

Levofloxacin

Children 6 months to 5 years of age

Children >5 years of age

10 mg/kg

10 mg/kg

q12 h

q 24 h

500 mg


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Amikacin


15–22.5

mg/kg/d

q 24 h

Gentamicin 5-7.5 mg/kg/d q 24 h If normal renal function

Meropenem

Infants ≥3 months of age and children

20 mg/kg q 8 h 1 g

Imepenem-cilastin

Infants < 3 months of age

Infants > 3 months of age and children

100 mg/kg/d

60-100

mg/kg/d

Divided q 6 h

Divided q 6 h

4 g

Fluconazole 12 mg/kg/d q 24 h

Anidulafungin

Children 2– 17 years of age

1.5 mg/kg/day Limited experience

Micafungin

Children >2 years of age

1–4 mg/kg/day 150 mg Limited experience

Caspofungin

Children 3months-17 years

loading dose of

70 mg/m2/day

on day 1

followed by

50 mg/m2/day

thereafter

70 mg; may

increase to 70

mg/m2/day if

clinical

response

is inadequate.

Clindamycin 10 mg/kg/dose q 6-8 h 900 mg Q 8


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Chapter 8

Link To National Programme Current Guidelines For Treatment Of Specific Infections

(HIV, RTI& STI, Tuberculosis, Malaria, Dengue, Kala azar, Leptospirosis, Leprosy, Japanese Encphalitis,

Filariasis)

National AIDS control programme (NACP):

In 1986, following the detection of the first AIDS case in the country, the National AIDS Committee was constituted

in the Ministry of Health and Family Welfare. In 1992 India’s first National AIDS Control Programme (1992-1999)

was launched, and National AIDS Control Organisation (NACO) was constituted to implement the programme.

During NACP-II (1999-2006), the free ART (Antiretroviral therapy) programme was rolled out on April 1, 2004 in

eight government hospitals in six high prevalence states has since been scaled up to 400 ART centres where in a total

of around 16,00,000 patients have been registered in HIV care and nearly 6,00,000 patients are currently on ART. The

national programme provides free First line, alternate First line and Second line antiretroviral drugs to adults and

children as per their eligibility. NACO makes available with updated related infections antimicrobial therapy

guidelines on regular basis.

Following links can be refered for further details:

NACO Guidelines for Antiretroviral therapy for HIV-infected Adults and Adolescents 2013

http://www.naco.gov.in/upload/Policies%20&%20Guidelines/Antiretroviral%20Therapy%20Guidelines%20for

%20HIV-Infected%20Adults%20and%20Adolescents.pdf

National Guidelines on Second-line and Alternative First-line ART For Adults and Adolescents 2013

http://www.naco.gov.in/upload/Policies%20&%20Guidelines/National%20Guidelines%20on%20Second-

line%20and%20Alternative%20First-

line%20ART%20For%20Adults%20and%20Adolescents%20May%202013.pdf

Guidelines for Prevention and Management of Common Opportunistic Infections/Malignancies among HIV-

Infected Adult and Adolescent 2007

http://naco.gov.in/upload/Policies%20&%20Guidelines/7-

Guidelines%20for%20Prevention%20and%20Management%20of%20common%20opportunistic%20infections.

pdf

National Guidelines on Prevention, Management and Control of Reproductive Tract Infections and Sexually

Transmitted Infections 2014

http://www.naco.gov.in/upload/2014%20mslns/National%20RTI%20STI%20technical%20guidelines%20Sep20

14.pdf

Revised National Tuberculosis Control Programme (RNTCP) DOTS-PLUS:

The Revised National TB Control Programme (RNTCP), an application of the WHO recommended Directly

Observed Treatment, Short Course (DOTS) strategy was launched in 1992 with the objective of detecting at least

70% of new sputum positive TB patients and curing at least 85% of such patients.

However the emergence of resistance to drugs used to treat tuberculosis, and particularly multidrug-resistant TB

(MDR-TB), has become a significant public health problem in a many countries. In India, the available information

from the several studies conducted in the past suggests that the rate of MDR-TB is relatively low in India. Yet this

translates into a large absolute number of cases. Specific measures are being taken within the Revised National

Tuberculosis Control Programme (RNTCP) to address the MDR-TB problem through appropriate management of

patients and strategies to prevent the propagation and dissemination of MDR-TB.

Revised National Tuberculosis Control Programme (RNTCP) DOTS-PLUS Guidelines 2010–

http://health.bih.nic.in/Docs/Guidelines/Guidelines-DOTS-Plus.pdf

National Vector Borne Disease Control Programme (NVBDCP):

NVBDCP Is an umbrella programme for prevention and control of vector borne diseases viz. Malaria, Japanese

Encephalitis (JE), Dengue, Chikungunya, Kala-azar and Lymphatic Filariasis. Out of these six diseases, two diseases


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http://www.naco.gov.in/upload/Policies%20&%20Guidelines/Antiretroviral%20Therapy%20Guidelines%20for%20HIV-Infected%20Adults%20and%20Adolescents.pdf

http://www.naco.gov.in/upload/Policies%20&%20Guidelines/Antiretroviral%20Therapy%20Guidelines%20for%20HIV-Infected%20Adults%20and%20Adolescents.pdf

http://www.naco.gov.in/upload/Policies%20&%20Guidelines/National%20Guidelines%20on%20Second-line%20and%20Alternative%20First-line%20ART%20For%20Adults%20and%20Adolescents%20May%202013.pdf



http://naco.gov.in/upload/Policies%20&%20Guidelines/7-Guidelines%20for%20Prevention%20and%20Management%20of%20common%20opportunistic%20infections.pdf



http://www.naco.gov.in/upload/2014%20mslns/National%20RTI%20STI%20technical%20guidelines%20Sep2014.pdf

http://www.naco.gov.in/upload/2014%20mslns/National%20RTI%20STI%20technical%20guidelines%20Sep2014.pdf

http://health.bih.nic.in/Docs/Guidelines/Guidelines-DOTS-Plus.pdf

58

namely Kala-azar and Lymphatic Filariasis have been targeted for elimination by 2015. Malaria, Filaria, Japanese

Encephalitis, Dengue and Chikungunya are transmitted by mosquitoes whereas Kala-azar is transmitted by sand-flies.

The transmission of vector borne diseases depends on prevalence of infective vectors and human vector contact,

which is further influenced by various factors such as climate, sleeping habits of human, density and biting of vectors

etc.

Following links can be referred for further details:

Dengue Clinical Management Guidelines 2014

http://nvbdcp.gov.in/Doc/Dengue-National- Guidelines-2014.pdf

Diagnosis and Treatment of Malaria Guidelines 2013

http://nvbdcp.gov.in/Doc/Diagnosis-Treatment-Malaria-2013.pdf

Operational Guidelineson Kala-Azar (Visceral Leishmaniasis) Elimination in India 2015

http://nvbdcp.gov.in/Doc/opertional-guideline-KA-2015.pdf

National Guidelines Diagnosis, Case Management Prevention and Control of Leptospirosis 2015

http://www.ncdc.gov.in/writereaddata/mainlinkfile/File558.pdf

Operational Guidelines on Disability Prevention & Medical Rehabilitation under National Leprosy

Eradication

Program 2012

http://nlep.nic.in/pdf/Guidelines%20for%20Primary,%20Secondary%20and%20TLC%20(Atul%20Shah%2

0247.2012.pdf

Guidelines on clinical management of acute encephalitis syndrome including Japanese encephalitis 2009

http://nvbdcp.gov.in/Doc/Revised%20guidelines%20on%20AES_JE.pdf

Guidelines on Filariasis Control in India & Its Elimination

http://nvbdcp.gov.in/doc/guidelines-filariasis-elimination-india.pdf


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http://nvbdcp.gov.in/Doc/Dengue-National-%20Guidelines-2014.pdf

http://nvbdcp.gov.in/Doc/Diagnosis-Treatment-Malaria-2013.pdf

http://nvbdcp.gov.in/Doc/opertional-guideline-KA-2015.pdf

http://www.ncdc.gov.in/writereaddata/mainlinkfile/File558.pdf

http://nlep.nic.in/pdf/Guidelines%20for%20Primary,%20Secondary%20and%20TLC%20(Atul%20Shah%20247.2012.pdf

http://nlep.nic.in/pdf/Guidelines%20for%20Primary,%20Secondary%20and%20TLC%20(Atul%20Shah%20247.2012.pdf

http://nvbdcp.gov.in/Doc/Revised%20guidelines%20on%20AES_JE.pdf

http://nvbdcp.gov.in/doc/guidelines-filariasis-elimination-india.pdf

59

Chapter 9

Case Definitions and Diagnosis for Common Infections

DIARRHEA

“Diarrhea” is an alteration in a normal bowel movement characterized by an increase in the water content, volume, or

frequency of stools. A decrease in consistency (i.e., soft or liquid) and an increase in frequency of bowel movements to ⩾3

stools per day have often been used as a definition for epidemiological investigations.

“Infectious diarrhea” is diarrhea due to an infectious etiology, often accompanied by symptoms of nausea, vomiting, or

abdominal cramps.

“Acute diarrhea” is an episode of diarrhea of <14 days in duration. “Persistent diarrhea” is diarrhea of >14 days in

duration.

ENTERIC FEVER

Acute non-complicated disease: Acute typhoid fever is characterized by prolonged fever, altered bowel function (constipation

in adults, diarrhea in children), headache, malaise and anorexia. Bronchitic cough and exanthem (rose spots on chest ,

abdomen, and trunk) may be seen in the early disease.

Complicated disease: Severe disease can have abdominal pain, occult blood in stools, malena, perforation peritonitis,

myocarditis, pneumonitis and enteric encephalopathy.

Case definition

Confirmed case of typhoid fever

A patient with fever (38°C and above) that has lasted for at least three days, with a laboratory-confirmed positive culture

(blood, bone marrow, bowel fluid) of S. typhi.

Probable case of typhoid fever

A patient with fever (38°C and above) that has lasted for at least three days, with a positive serodiagnosis or antigen detection

test but without S. typhi isolation.

SPONTANEOUS BACTERIAL PERITONITIS

The diagnosis of spontaneous bacterial peritonitis (SBP) is made in transudative ascitis with increased absolute

polymorphonuclear leukocyte (PMN) count (i.e., ≥250 cells/mm3

[0.25 x 109/L]) and without an evident intra-abdominal,

surgically treatable source of infection. An abdominal paracentesis must be performed and ascitic fluid must be analyzed

before a confident diagnosis of ascitic fluid infection can be made.

ACUTE PANCREATITIS

Acute inflammation of pancreas, usually caused by alcohol or gallstone migrating through the common bile duct. Less

commonly caused by trauma, infections like mumps, ascariasis and drugs like diuretic, azathioprine, etc.

Routine use of prophylactic antibiotics in patients with severe AP is not recommended. The use of antibiotics in patients

with sterile necrosis to prevent the development of infected necrosis is not recommended.

Infected necrosis should be considered in patients with pancreatic or extrapancreatic necrosis who deteriorate or fail to

improve after 7 – 10 days of hospitalization. In these patients, either (i) initial CT-guided fi ne-needle aspiration (FNA) for

Gram stain and culture to guide use of appropriate antibiotics or (ii) empiric use of antibiotics after obtaining necessary

cultures for infectious agents, without CT FNA, should be given.

If diarrhoea present WITH vomiting, low grade fever with no mucus in stools think of viral infection.

If diarrhoea present WITH vomiting, abdominal cramps, blood and mucus in stools WITH fever, think

of bacterial infection.

If diarrhoea present WITH blood and mucus in stool WITH no fever, think of amoebiasis.

If profuse diarrhoea present (rice water stools) WITH vomiting, think of cholera.

If diarrhoea present WITH excessive vomiting (especially if in more than one member of the

household or group) think of food poisoning.


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In patients with infected necrosis, antibiotics known to penetrate pancreatic necrosis, such as carbapenems, quinolones, and

metronidazole, may be useful in delaying or sometimes totally avoiding intervention, thus decreasing morbidity and mortality.

ACUTE BACTERIAL MENINGITIS

Acute bacterial meningitis (ABM) is a potentially life-threatening neurological emergency.

Patients generally presents with short history of high-grade fever with prominent headache, neck stiffness, photophobia,

nausea, vomiting and altered mental status (lethargy to coma). Infants, elderly, and immunocompromised patients may show

only mild behavioural changes with low-grade fever and little clinical evidence of meningeal inflammation.

Patients with ABM should be rapidly hospitalized and assessed for consideration of lumbar puncture (LP) if clinically safe.

Ideally, patients should have fast-track brain imaging before LP, but initiation of antibiotic therapy should not be delayed

beyond 3 h after first contact of patient with health service.

CSF examination reveals elevated pressure (200-500 mm H2O) and protein (100- 500 mg/dl, normal 15-45 mg/dl), decreased

glucose (<40% of serum glucose) and marked pleocytosis (100-10,000 white blood cells/μl, (normal <5) with 60% or greater

polymorphonuclear leucocytes.

Pyogenic meningitis should be differentiated from tubercular meningitis, which has relatively longer history of low to high

grade of fever, constitutional symptoms, and CSF shows lymphocytic predominance, normal to mildly reduced sugar and

raised proteins.

BRAIN ABSCESS

Brain abscess is defined as a focal suppurative infection within the brain parenchyma, typically surrounded by a well-

vascularized capsule. The most important investigation to diagnose brain abscesses is cranial imaging, either cranial

tomography (CT) or magnetic resonance imaging (MRI).

Headache is the most common presenting symptom of brain abscess. Fever is generally present but its absence does not rule

out the diagnosis. Mostly patients have a focal neurologic deficit such as hemiparesis, apahasia, visual field defects depending

on the location of abscess.

INFECTIVE ENDOCARDITIS

Bacterial endocarditis is a life-threatening infectious disease. Clinical manifestations of bacterial endocarditis include fever,

toxaemia, clubbing, splenomegaly, anaemia, microscopic haematuria, a new onset or changing murmur, evidence of immune

phenomena such as roth spots, osler nodes.

The diagnosis of bacterial endocarditis is based on Modified Duke s criteria which involves clinical, laboratory and

echocardiographic findings.

Definite IE

Pathological criteria

Microorganisms demonstrated by culture or on histological examination of a vegetation, vegetation that has

embolized, or an intracardiac abscess specimen; or

Pathological lesions; vegetation or intracardiac abscess confirmed by histological examination showing active

endocarditis

Clinical criteria

2 major criteria; or

1 major criterion and 3 minor criteria; or

5 minor criteria

Possible IE

1 major criterion and 1 minor criterion; or

3 minor criteria

Rejected IE

Firm alternate diagnosis; or

Resolution of symptoms suggesting IE with antibiotic therapy for ≤4 days; or

No pathological evidence of IE at surgery or autopsy, with antibiotic therapy for ≤4 days; or

Does not meet criteria for possible IE, as above

Modified Duke s criteria for diagnosis of endocarditis

Major Criteria

1. Blood cultures positive

a. Typical microorganisms consistent with IE from 2 separate blood cultures


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Viridans streptococci, Streptococcus gallolyticus (Streptococcus bovis), HACEK group, Staphylococcus aureus; or

Community-acquired enterococci, in the absence of a primary focus; or

b. Microorganisms consistent with IE from persistently positive blood culture

≥2 positive blood cultures of blood samples drawn >12 h apart; or

All of 3 or a majority of ≥4 separate cultures of blood (with first and last samples drawn ≥1 h apart); or

c. Single positive blood culture for Coxiella burnetii or phase I IgG antibody titre >1:800

2. Imaging positive for IE

a. Echocardiogram positive for IE

Vegetation;

Abscess pseudoaneurysm, intracardiac fistula

Valvular perforation or aneurysm;

New partial dehiscence of prosthetic valve

b. Abnormal activity around the site of prosthetic valve implantation detected by “F-FDG PET/CT (only if the

prosthesis was implanted for >3 months) or radiolabelled leucocytes SPECT/CT

c. Definite paravalvular lesions by cardiac CT

Minor Criteria

1. Predisposition such as predisposing heart condition, or injection drug use

2. Fever defined as temperature >38°C

3. Vascular phenomena (including those detected by imaging only): major arterial emboli, septic pulmonary infarcts,

infectious (mycotic) aneurysm, intracranial haemorrhage, conjunctival haemorrhages, and Janeway’s lesions

4. Immunological phenomena: glomerulonephritis. Osler’s nodes, Roth’s spots, and rheumatoid factor

5. Microbiological evidence: positive blood culture but does not meet a major criterion as noted above or serological

evidence of active infection with organism consistent with IE

CELLULITIS

Cellulitis is an acute spreading infection that involves subcutaneous tissue, most commonly caused by group a streptococcus

and staph aureus. Trauma and underlying skin lesion can lead to the development of cellulitis. Cellulitis may also develop due

to the spread of adjacent infections like osteomyelitis.

Clinical findings: Clinically rapidly intensifying pain and redness is a common presentation. Fever and lymphadenopathy may

be present. The borders in cellulitis are not well demarcated. Though group A streptococci and staphylococcus are the most

common organisms rarely organisms like H influenza, pneumococcus may also cause cellulitis.

FURUNCULOSIS

Furunculosis is a deep infection of the hair follicle leading to abscess formation with accumulation of pus and necrotic tissue.

Furuncles appear as red, swollen, and tender nodules on hair-bearing parts of the body, and the most common infectious agent

is Staphylococcus aureus, but other bacteria may also be causative. Furunculosis often tends to be recurrent and may spread

among family members.

A carbuncle is a coalescence of several inflamed follicles into a single inflammatory mass with purulent drainage from

multiple follicles.

URINARY TRACT INFECTIONS

The term UTI encompasses a variety of clinical entities viz asymptomatic bacteriuria (ASB), cystitis, prostatitis and

pyelonephritis.

Uncomplicated UTI refers to acute cystitis or pyelonephritis in non pregnant outpatient women without anatomic abnormalities

or instrumentation of urinary tract. Complicated UTI includes all other types of UTI.

Cystitis: The typical symptoms of cystitis are dysuria, urinary frequency, and urgency. Other symptoms are nocturia,

hematuria, suprapubic discomfort, and hesitancy.

Pyelonephritis : severe pyelonephritis present as high fever, rigors, nausea, vomiting, flank or loin pain.symptoms are acute in

onset and symptoms of cystitis may not be present. Fever is the main distinguishing feature between cystitis and

pyelonephritis.

Prostatitis: Acute bacterial prostatitis presents as dysuria, frequency and pain in pelvis or perineal area. Fever and chills are

usually present and symptoms of bladder outlet obstruction are common.

PNEUMONIA

Pneumonia is an inflammation in alveolar tissue, most often caused by a microbial agent. The community acquired pneumonia

is most commonly caused by Streptococcus pneumoniae (typical) and less frequently by Mycoplasma pneumoniae, H.

influenzae, Chlamydia pneumoniae, Staphylococcus aureus or Legionella pneumoniae (atypical). Haemophilus influenzae

infection is seen mostly in patients with chronic bronchitis. Nosocomial pneumonia is likely to be caused by Gram-negative

bacilli or Staphylococcus aureus.


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Sudden onset of fever, productive cough, chest pain, shortness of breath and (in some cases) pleuritic chest pain; systemic

symptoms like headache, bodyache and delirium are more severe with atypical pneumonia.

For assessment of the severity of pneumonia “CURB- 65” severity score can be used-

Confusion,

Urea >7 mmol/l,

Respiratory rate ≥30/min,

low Blood pressure (diastolic blood pressure (DBP) ≤ 60 mm Hg or systolic BP ≤ 90 mm Hg) and

Age ≥65 years

Patients with scores 0 and 1 are at low risk of mortality (1.5%) might be suitable for management as hospital outpatients.

Patients with a score of 2 are at intermediate risk of mortality (9%) and should be considered for hospital supervised treatment.

Patients with a score of >2 are at high risk of mortality (>19%) and requires ICU care.


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ABBREVIATIONS

AIDS Acute Immuno Deficiency Syndrome

ALT- Alanine Amino Transferase

AM-CL- Amoxicillin/clavulanate

AMR – Antimicrobial Resistance

ANC- Antenetal Care

AOM- Acute otitis media

ART- Anti retroviral treatment

AST- Anti microbial susceptibility test

ATT- Anti Tubercular Treatment

BAL- Broncho Alveolar lavage

BCG- Bacillus Calmette Guerin

BD- Bis in Die (12 hourly)

BL-BLI- Beta lactam-beta-lactam inhibitor

BMT- Bone Marrow Transplantation

BP- Blood Pressure

CABG- Coronary Artery Bypass graft

CAPD- Continuous Ambulatory Peritoneal Dialysis

CI- Confidence Interval

CLSI- Clinical and Laboratory Standards Institute

CME- Continuing medical education

CMV- Cyto Megalo Virus

CNS-Central Nervous System

CRBSI-Catheter Related Bloodstream Infection

CRP- C reactive protein

CRS-Congenital Rubella Syndrome

CSF- Cerebro Spinal Fluid

CSSD- Central Stores and Supply Department

CTVS- Cardio Thoracic and Vascular Surgery

CVS- Cardiovascular System

DS- Double Strength

DT-Dispersible Tablet

DVT- Deep Venous Thrombosis

E.T.O-Ethylene Oxide Sterizilation

ECG- Echo Cardio Gram

ECHO- Echo Cardio Graphy

EGA-Estimated Gestational Age

ENT-Ear Nose Throat

ESBL-Extended-Spectrum Beta- Lactamase

ESRD- End Stage Renal Disease

FDA- Food and Drug Authority

FQ- Fluoroquinolone

G6PD- Glucose 6- phosphate dehydrogenase

GBS- Guillain Barre syndrome

GI-Gastro-Intestinal

HIV-Human Immunodeficiency Virus

HSV- Herpes Simplex virus

ICU-Intensive Care Unit

ID- Infectious disease

IU- International unit

IUD- Intra Uterine Device

IV-Intra Venous

LBW-Low Birth Weight

MDR-Multi Drug Resistant

MIC- Minimum Inhibitory Concentration

MRSA- Methicillin Resistant Staphylococus aureus

MSSA- Methicillin Sensitive Staphylococcus aureus

NICU- Neonatal Intensive Care Unit

OD- Once a day

OPD-Outdoor Patient Department

OT-Operation Theatre

PANDAS- Pediatric Autoimmune Neuropsychiatric

Disorders Associated with Streptococcal Infections

PCR- Polymerase chain reaction

PICU-Pediatric Intensive Care Unit

PJI-Periprosthetic Joint Infection

RNTCP-Revised National Tuberculosis Control Programme

RTI- Reproductive tract infection

SOP- Standard operating procedure

STI-Sexually Transmitted Infection

TB-Tuberculosis

TDS - Ter die sumendum (8 hourly)

TMP-SMX- Trimethoprim sulphamethoxazole

TMP-SMX-DS- Trimethoprim sulphamethoxazole double

strength

URI-Upper Respiratory Infection

UTI-Urinary Tract Infection

VAP-Ventilator Associated Pneumonia

HAP-Hospital Acquired Pneumonia

VDRL-Venereal Disease Research Laboratory

VRE-Vancomycin Associated Enterococci

VZIG- Varicella Zoster immunoglobulin

WBC-White Blood Cell

WHO-World Health Organization


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64

LIST OF EXPERTS

Authors-

Dr..S. Venkatesh, Director, National Centre for Disease Control, New Delhi.

Dr..L.S. Chauhan, Ex-Director, National Centre for Disease Control, New Delhi.

Dr. A. K. Gadpayle, Director PGIMER and Medical Superintendent Dr. RML Hospital, New Delhi

Dr. T. S. Jain, President, Hospital Infection Control Society, India

Dr. Chand Wattal, Senior Consultant, Clinical Microbiology, Sir Ganga Ram Hospital, New Delhi

Dr. S. Aneja, Director Professor, Paediatrics, Kalawati Saran Children Hospital & Lady Hardinge Medical College, New Delhi

Dr. Abdul Ghafur, Consultant Infectious Diseases & Clinical Microbiology, Apollo Hospital, Chennai

Dr. Manju Puri, Professor &Head Gynecology and Obstetrics, Lady Hardinge Medical College and Smt Sucheta Kriplani Hospital, Delhi

Dr. Ajit Sinha, Head Surgery, Safadarjang Hospital, New Delhi

Dr. Varinder Singh, Professor Paediatrics, Kalawati Saran Children Hospital & Lady Hardinge Medical College, New Delhi

Dr. Usha Baveja, Senior Consultant, Microbiology, Medanta-The Medicity, Gurgaon, Haryana

Dr. Renu Dutta, Director Professor, Microbiology, Lady Hardinge Medical College, New Delhi

Dr. Rajni Gaind, Consultant and Professor, Head Microbiology,VMMC & Safdarjang Hospital, New Delhi

Dr. Raman Sardana, Head & Chairman, Hospital Infection Control & Microbiology, Indraprastha Apollo Hospitals, Sarita Vihar, NewDelhi.

Dr. Vikas Manchanda, Assistant Professor, Microbiology, Maulana Azad Medical College, New Delhi

Dr. Anita Kotwani, Ex-Associate Professor, Pharmacology, Vallabhbhai Patel Chest Institute, Delhi

Dr. Charoo Hans, Head Microbiology, PGIMER and associated Dr. RML Hospital, New Delhi

Dr. Sudha Chandelia, Assistant Professor, Pediatrics & Division of Critical care, PGIMER and associated Dr. RML Hospital, New Delhi

Dr. Piyush Jain, Assistant Professor, Medicine, PGIMER and associated Dr. RML Hospital, New Delhi

Dr. Shashi Khare, Ex-Additional Director, Microbiology, National Centre for Disease Control, New Delhi.

Dr. Sarika Jain, Assistant Director, Microbiology, National Centre for Disease Control, New Delhi.

Contributors/Reviewers-

Dr K. K. Aggarwal, Hon’ble Secretary General, Indian Medical Association, Delhi

Dr Jagdish Chandra, Director Professor & Head Paediatrics, Kalawati Saran Children Hospital & Lady Hardinge Medical College, Delhi

Dr.Anupam Prakash, Associate Professor, Medicine, Lady Hardinge Medical College & associated Smt Sucheta Kriplani Hospital, Delhi

Dr. Ravinder Kaur, Director Professor & Head Microbiology, Lady Hardinge Medical College, New Delhi

Dr. Sonal Saxena, Professor Microbiology, Lady Hardinge Medical College, New Delhi

Dr. Anil Garg, C.M.O. (SAG) Medicine, Deen Dayal Upadhayaya Hospital, New Delhi

Dr. Harish Gandhi, C.M.O. (SAG) Ophthalmology, Deen Dayal Upadhayaya Hospital, New Delhi

Dr. K. K. Kumra, C.M.O. (SAG) Orthopedics, Deen Dayal Upadhayaya Hospital, New Delhi

Dr. Manisha Jhawar, President Elect, Surat Ob & Gyn Society, Surat, Gujarat

Dr. Anurag Aggarwal, Assistant Professor, Pediatrics, Maulana Azad Medical College and associated Lok Nayak Hospital, New Delhi

Dr. Narender Saini, Former Hon’ble Secretary General, Indian Medical Association, Delhi

Dr. Rakesk Kumar. Mahajan, Professor & Consultant, Microbiology, PGIMER and associated Dr. RML Hospital, New Delhi

Dr. Kamini Walia, Sr. Scientist, Indian Council of Medical Research, Ansari Nagar, New Delhi

Dr. Padmini Srikantiah, Senior Medical Epidemiologist, Centers for Disease Control and Prevention, Delhi

Dr. S. Roy Choudhury, Professor & Head, Kalawati Saran Children Hospital & Lady Hardinge Medical College, New Delhi

Dr. Sunil Gupta, Additional Director and Head, Microbiology, National Centre for Disease Control, New Delhi.


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Central Drugs Standard Control Organization Directorate General of Health Services, Ministry of Health and Family Welfare, Government of India

Page 1 of 12

Frequently asked Questions on Medical Devices

Central Drugs Standard Control Organization

(Medical Devices and Diagnostic Division)

Frequently Asked Questions on

Registration and Import of Medical Devices

in India

Doc No.: CDSCO/MD/FAQ/RC/01/00

Date :21-02-2013

CENTRAL DRUGS STANDARD CONTROL ORGANIZATION

DIRECTORATE GENERAL OF HEALTH SERVICES

MINISTRY OF HEALTH & FAMILY WELFARE

GOVT. OF INDIA

Notice: The replies to the FAQs are aimed only for creating public awareness about In-Vitro Diagnostic Devices Regulation by CDSCO and are not meant to be used for legal or professional purposes. The readers are advised to refer to the statutory provisions of Drugs and Cosmetics Act & Rules and respective Guidelines / Clarifications issued by CDSCO time to time for all their professional needs.


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MEDICAL DEVICE REGULATIONS

1. What is a medical device in India? Ans:such devices intended for internal or external use in the diagnosis, treatment, mitigation or prevention of disease or disorder in human beings or animals, as may be specified from time to time by the Central Government by notification in the Official Gazette, after consultation with the Board.

2. Whether medical devices are regulated in India? Ans:Yes, import, manufacture, sale and distribution of medical devices are regulated in India under the provisions of the Drugs & Cosmetic Act 1940 & Rules 1945.

3. Where can we get a copy of the Drugs & Cosmetic Act 1940 & Rules 1945?

Ans: The copy of the Drugs & Cosmetic Act 1940 & Rules 1945 is available in Link: http://cdsco.nic.in/Drugs&CosmeticAct.pdf

4. Whether all medical devices are regulated in India?

Ans: No, however only notified medical devices are regulatedin India. The following medical devices are notified under the Drugs and Cosmetics Act.

Name of the Device Notification Number

Date of Notification

Disposable Hypodermic Syringes GSR 365 (E) 17-03-1989

Disposable Hypodermic Needles GSR 365 (E) 17-03-1989

Disposable Perfusion Sets GSR 365 (E) 17-03-1989

In-vitro Diagnostic Devices for HIV, HbsAg and HCV GSR 601(E) 27-08-2002

Cardiac Stents S.O. 1468 (E) 06-10-2005

Drug Eluting Stents S.O. 1468 (E) 06-10-2005

Catheters S.O. 1468 (E) 06-10-2005

Intra Ocular Lenses S.O. 1468 (E) 06-10-2005

I.V. Cannulae S.O. 1468 (E) 06-10-2005

Bone Cements S.O. 1468 (E) 06-10-2005

Heart Valves S.O. 1468 (E) 06-10-2005

Scalp Vein Set S.O. 1468 (E) 06-10-2005

Orthopaedic Implants S.O. 1468 (E) 06-10-2005

Internal Prosthetic Replacements S.O. 1468 (E) 06-10-2005


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http://cdsco.nic.in/Drugs&CosmeticAct.pdf


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5. Which is the Regulatory Authority that governs the regulations of Import of medical devices in India? Ans:Drugs Controller General (India), Central Drugs Standard Control Organization (CDSCO), Directorate General of Health Services , Ministry of Health and Family Welfare, Government of India , FDA Bhavan, ITO, Kotla Road, New Delhi -110002 Phone: 91-11-23236965 / 23236975, Fax: 91-11-23236973, E-mail:- [email protected]

6. Which division of CDSCO (HQ) is responsible for registration/import of Medical

Devices in India? Ans: Medical Device & Diagnostics Division, Central Drugs Standard Control Organization (CDSCO), Directorate General of Health Services, Ministry of Health and Family Welfare, Government of India FDA Bhavan, ITO, Kotla Road, New Delhi -110002 is responsible for registration/import of Medical Devices in India.

7. What are the requirements for import of medical devices in India?

Ans: For the import of medical devices in India, Registration Certificate in Form 41 and Import License in Form 10 are required as per provisions of the Drugs & Cosmetic Act & Rules. For import of medical device, the manufacturing site and products (medical devices) are required to be registered with Indian drug regulatory agency (i.e. Central Drugs Standards Control Organization).

8. Whether Registration and import license is required for import of non-notified

medical device in India? Ans:No, registration is not required for import of non-notified medical devices in India. However, the followingdevices are regulated as “Drugs” under Drugs and Cosmetics Act and Rules, hence registration and import license is required for import in to India. Blood Grouping Sera Ligatures, Sutures, Staples Intra Uterine Devices (Cu-T) Condoms Tubal Rings Surgical Dressing Umbilical Tapes Blood / Blood Component Bags

9. Who canimport medical devices into India?

Ans: Any person/firm/enterprise etc. having wholesale license and/or manufacturing license issued under Drugs and Cosmetics Act, 1940 and Rules 1945 can be an applicant for Registration and import of medical devices into India.

10. To whom shall the application be submitted for Registration/Import License for

Medical Device in India? Ans. Applications for Registration/ Import Licenseof Medical Device shall be submitted to the Drugs Controller General (India), Central Drugs Standard Control Organization (CDSCO), FDA Bhawan, ITO, Kotla Road, Delhi-110002. Phone: 91-11-23236965 / 23236975. Fax: 91-11-23236973.


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11. What is the procedure to apply for the "Registration certificate" in Form-41 for Medical Devices in India? Ans:Following steps may be adopted for Registration application STEP 1.Pay the required Registration fee through TR-6 Challan (in triplicate) in Bank of Baroda, Kasturba Gandhi Marg, New Delhi.

A fee of one thousand and five hundred US dollars [or its equivalent in Indian rupees] shall be paid along with the application in Form 40 as registration fee for the manufacturing premises meant for manufacturing of medical device intended for import into and use in India.

A fee of one thousand US dollars [or its equivalent in Indian rupees] shall be paid along with the application in Form 40 for the registration of a single medical device meant for import into and use in India and an additional fee at the rate of one thousand US dollars for each additional medical device:

STEP 2.Compilation of Registration dossier as per the guidance documents available atthe link:http://cdsco.nic.in/Medical_div/guidance.htm

STEP 3.Submit Product Registration application at CDSCO (HQ), New Delhi

12. Whether Device manufacturing site required to be inspected before grant of

Registration Certificate in Form 41? If yes, how much fees for the inspection or visit of the manufacturing premises of Medical Devices? Ans:No, however if required the applicant shall be liable for the payment of a fee of five thousand US dollars [or its equivalent in Indian rupees] for expenditure as may be required for inspection or visit of the manufacturing premises.

13. How the fees shall be paid in India?

Ans: The fees shall be paid through a Challan in the Bank of Baroda, Kasturba Gandhi Marg, New Delhi-110001 or any other branch or branches of Bank of Baroda, or any other bank, as notified, from time to time, by the Central Government, to be credited under the Head of Account “0210-Medical and Public Health, 04-Public Health, 104-Fees and Fines”: Provided that in the case of any direct payment of fees by a manufacturer in the country of origin, the fees shall be paid through Electronic Clearance System (ECS) from any bank in the country of origin to the Bank of Baroda, Kasturba Gandhi Marg, New Delhi, through the Electronic Code of the bank in the Head of Account “0210-Medical and Public Health, 04- Public Health, 104-Fee and Fines”, and the original receipt of the said transfer shall be treated as an equivalent to the bank challan, subject to the approval by the Bank of Baroda that they have received the payment.

14. Is there any system of prescreening of applications for issue of grant of

Registration Certificate/ Import Licence at the time of submission at CDSCO (HQ) New Delhi? Ans: Yes, application will be prescreened as per checklist available under link: http://cdsco.nic.in/Medical_div/medical_device_division.htm


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15. What is the time period for Grant of Registration Certificate? Ans: If the application is complete in all respects and informations specified in Schedules D-I and D-II are in order, the licensing authority shall, within nine months from the date of receipt of an application, issue such Registration Certificate in From 41.

16. What is the Duration/Validity of "Registration certificate" in Form-41 for Medical

Devices in India? Ans:A Registration Certificate, unless, it is sooner suspended or cancelled, shall be valid for a period of three years from the date of its issue

17. How to register additional device(s) in the already approved/valid Registration

Certificate? Ans.Importer has to apply for endorsement to the existing Registration Certificate along with the requisite documents provided that the additional device(s) is being manufactured at the same manufacturing site as stated in the Registration Certificate for each additional device 1000 USD is to be paid as a Registration fee. The requirements for endorsement of additional Device(s) to the valid Registration Certificate are remains same to the fresh Registration Certificate except Site Registration Fees (1500 USD) and Plant Master File.

18. When should an application for Re-Registration of devices be submitted?

Ans. Applications for Re-Registration should be submitted minimum Nine months ahead of the expiry of the registration certificate.

19. What are the requirements for Re-Registration of devices?

Ans. The requirements for Re-registration of Devices are remains same as fresh Registration requirements except requirement of hard copy of Plant Master File (PMF) and Device Master File (DMF) provided there are no changes in the PMF and DMF, However soft copy of PMF and DMF in the form of compact disc shall be provided along with the application.

20. Is it possible for an applicant to submit their applications for Registration

Certificate (Form 41) and Import License (Form 10) together? Ans.Yes, an applicant can apply for both Registration Certificate (Form 41) and Import License (Form 10) together,provided Indian agent and importer remain same

21. How much fees for issuance of duplicate copy of "Registration certificate" in Form-

41 for Medical Devices in India? Ans: A fee of three hundred US dollars [or its equivalent in Indian rupees] shall be paid for a duplicate copy of the Registration Certificate, if the original is defaced, damaged or lost.

22. What are the requirements for grant of Import license in Form 10 of Medical

Devices? Ans.The requirements for grant of import license in Form 10 are available in the CDSCO web page under link i.ehttp://cdsco.nic.in/Medical_div/medical_device_division.htm


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23. What is the Duration/Validity of "Import Licence” in Form-10 for Medical Devices in

India? Ans: Import Licence, unless, it is sooner suspended or cancelled, shall be valid for a period of three years (Till Registration Certificate is valid).

24. When should an application for renewal of Import Licencebe submitted?

Ans.Applications for Import Licence should be submitted along with the application for Re-Registration provided importer and Indian Agent are remain same or minimum three months ahead of the expiry of the Import Licence.

25. Whether Devices, having valid Import Licence, can be imported from any notified

ports of India? Ans.Yes,

26. Whether multiple Import Licences are required for devices that are registered under

one Registration Certificate by the same Indian Agent/ Importer in case he wants to import from different notified ports? Ans. No.Single license may be issued, in respect of the import of more than one drug or class of drugs manufactured by the same manufacturer to the Importer through which importer can import the products thorough any notified port under Drugs and Cosmetics Act and Rules.

27. Whether devices imported under valid import Licence can stocked in any other

wholesale licence premises other than stated in the Import Licence? Ans. Yes

28. What is the time period for Grant of Import licence?

Ans: If the application is complete in all respects and informations are in order, the licensing authority may within three months from the date of receipt of an application, issue an import licence in Form 10.

29. Whether Notified Medical Devices can be imported only for demo purpose into

India? Ans. No,there is no provision to import demo samples in India.

30. What is the Test license in Form 11?

Ans:The Test Licence in Form 11 is to import small quantities of drugs / Medical Devices/ Diagnostic kits, for the purpose of examination, test or analysis provided that Imported Medical Devices under Form 11 shall not be used for any commercial purposes.

31. What are essential documents required for import of medical device for

examination, test and analysis in Form11? Ans:The essential documents required for Import of devices under test Licence are available in CDSCO website under Link: http://cdsco.nic.in/Medical_div/medical_device_division.htm


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32. What is the Duration/validity of "Test License" in Form-11? Ans:A Test License unless, it is sooner suspended or cancelled, shall be valid for a period of one year from the date of its issue

33. Whether Registration Certificate and Import Licence are required to import

componentsof Medical Devices? Ans.Yes, Devices in assembled form ready for packaging and sterilization are regulated under the provision of Drugs and Cosmetic Act 1940 and Rules thereunder. Hence Registration Certificate and Import Licence are required to import into India.

34. Whether both legal (If any) and actual manufactures name and address should be

stated in the Free Sale Certificate issued by the national Regulatory agency for the purpose of registration of devices in India? Ans.Yes.

35. Any changes in name and/oraddress of Indian agent/ Importer or change in

constitution after issue of Registration Certificate/ Import Licence are required to be communicated to the Licensing Authority? Ans.Yes, Indian agent/ Importer shall inform the licensing authority immediately in writing and shall submit fresh application as per Rules.

36. Any changes in name and/or address of legal and/or actual manufacturer or change

in constitution after issue of Registration Certificate/ Import Licence are required to be communicated to the Licensing Authority? Ans. Yes, the manufacturer or his authorizd agent in india shall inform the licensing authority immediately in writing in the event of any change in the constitution of the firm and / or address of the registered office / factory premises operating under this Registration Certificate. Where any such change in the constitution of the firm and/or address takes place, the current Registration Certificate shall be deemed to be valid for a maximum period of three months from the date on which the change has taken place unless, in the meantime, a fresh Registration Certificate has been taken from the licensing authority in the name of the firm with the changed constitution of the firm and/or changed address of the registered office or factory premises

37. Whether acquisition/merger of one company by another company is considered as

change in constitution of the company? Ans.Yes.

38. What are the changes that require an applicant to make afresh Registration?

Ans.The following changes require a fresh registration – Any change with respect to manufacturer (legal/ actual) like change in constitution, change in name, change in address, etc. Any change with respect to importer/ Indian Agent like change in constitution, change in name, etc.

39. What are the changes which do not require fresh registration and only notification

or amendment may be obtained?


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Ans.Change in shelf life, change in the method of testing, minor change in manufacturing process not affecting the final product specifications, updation in IFU like warnings, precautions, additional instructions and safety etc., labels and packaging (provided proper justification should be provided for the above changes).

40. If there is a change in the Indications and/ or Intended use of a registered notified

medical device, does the applicant need to submit a fresh application including Power of Attorney incorporating the changed Indications and/ or Intended use of the registered notified medical device? Ans.Yes, revised Power of Attorney is required to be submitted, reflecting the changes/ modification to indications.

41. What is the procedure for expanding/ modifying the currently registered

indications? Ans.The process for change notification to CDSCO and approval will be followed in such case. Revised Power of Attorney including the expanded/ modified indication will need to be submitted to the CDSCO.

42. Whether any minor change which is notified to the Regulatory Authority but

CDSCO’s response is awaited can be imported in India? Ans.NO.

43. What is the time line for response to a change notification?

Ans. 90 working days. 44. At the time of submitting applications for registration/ re-registration of medical

devices, are original labels as per Rule 96 to be submitted to the CDSCO? Ans. While original labels as per Rule 96 are required however applicants may submit coloured copy of original label incorporating all details as per Rule 96. Labels submitted should include all models for which registration is sought.

45. What are mandatory addresses on the labels of registered notified medical devices

being imported/ marketed in India? Ans. The label of registered notified medical devices being imported must include the names and addresses of the legal manufacturer, actual manufacturer and the name and address of importer on which the Import License in Form 10 has been issued.

46. Can the importers of registered notified medical devices incorporate India-specific

requirements on labels after/post landing in India at customs warehouse or place approved by the Licensing Authority? Ans. Yes, importers of registered notified medical devices are currently allowed to incorporate India-specific requirements like name and address of importer, import Licence Number on imported medical devices post landing in India at customs warehouse or place approved by the CDSCO prior to release into market.

47. Can the Quality Manual as per ISO 13485 be submitted in lieu of the Plant Master

File? Ans.Yes. Provided Quality Manual has same content as prescribed in Plant Master File.


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48. The numbers of employees in the manufacturing premise are required to be

included in the Plant Master File? However, there may be a change in this number by the time the Plant Master File is collated and submitted? Ans.Yes, the number of employees as on the date of preparation of Plant Master File will be considered for the purpose of registration.

49. Whether Certificate of Exportability (which reflects that the proposed products may

not be freely sold in the country of origin but can be exported), is acceptable as Free Sale Certificate? Ans.No

50. Which manufacturing site is considered the manufacturing premise for the purpose

of inclusion in the Form - 40? Ans.The actual site of final batch release of the medical device is considered the manufacturing premise for the purpose of inclusion in the Form – 40.

51. If applicant has applied for Registration Certificate and still not issued but in

between there is the change has happened in the constitution of either Manufacturer or Indian Agent, address of manufacturer whether fresh fees is required for plant registration and product registration? Ans. Yes. The applicant has to submit the Fresh application including fee.

52. If applicant wants to apply for Registration Certificate but the product is not being

sold in any of the following countries i.e. USA, Europe, Japan, Health Canada or Australia. Can he apply for Registration Certificate? Ans. No. However if safety and effectiveness of device is proven by conducting clinical trials in India can apply for registration certificate.

53. If applicant wants to apply for Registration Certificate but the product is not sold in

the country of origin but is registered and marketed in any one of the following countries i.e. USA, Europe, Japan, Health Canada or Australia. Can he apply for Registration Certificate? Ans. Yes.

54. What is the generic name of the medical device?

Ans. The generic name is the name as per the internationally accepted nomenclature for the medical device.

55. What is a “new” medical device?

Ans. A “new” medical device is one which does not have a predicate medical device registered / approved in India.

56. What is a “predicate” medical device?

Ans. A “predicate” medical device is one which is registered / approved in India and has the same indications/ intended use, material of construction and design characteristics as the device which is proposed for registration in India.


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57. How is the process for registration of a “new” medical device different from that of a medical device for which predicates exist? Ans. Notified medical devices for which predicate devices are not registered in India are classified as “new” medical devices. These medical devices are referred to the Medical Device Advisory Committees (MDAC) to comment on safety, effectiveness, essentiality and desirability of proposed New Devices.

58. Which are the Specialties for which Medical Device Advisory Committees exist?

Ans. Currently, Medical Device Advisory Committees cover the following specialties –Cardiovascular, Dental, Ophthalmic, Orthopaedic, Reproductive and Urology and a miscellaneous devices committee. Further, the CDSCO has also formulated a “General Expert Pool” for Medical Device Advisory Committee to advise the Drugs Controller General of India in matters related to review and regulatory approval of new medical devices and clinical trials.

59. Who will issue Form-9 the manufacturer or the Principle Indian Agent?

Ans.Form-9 can be issued by either the manufacturer OR the Principle Indian Agent. 60. How should the documents be notarized?

Ans.The notary should ensure that documents are properly authenticated by signing each document/page or by providing notarization page (Declaration from notary) having name/number of certificate/documents along with pages eg. “This part includes certificate X (pages), Certificate Y (pages)” etc. and should be intact (Authorized by notary tamper proof) and stapling or pasting not accepted.

61. What is the time limit for submission of Query Response?

Ans. There is no time limit for submission of Query Response as per the provision of Drugs and Cosmetics Act and Rules, however, it should be reasonable and justifiable.

62. Can Third party/Authorized Consultant ask the status of the application?

Ans. No. Only either applicant or his authorized Regular employee may ask the status of their application if it is beyond the time limit prescribed under Drugs and Cosmetics Act and Rules.

63. Who is authorized to make a Technical Presentation, on behalf of applicant, when

asked by the CDSCO? Ans. Only Subject Expert or Technical Person of the company who is equally competent to make technical presentation.

64. Whether the Importer who is having valid Form-10 license but there is some small

change in the name of importer or address of Importer still can he import till another license is granted? Ans. No, at the time of import, the label of the product should comply with details as specified in the Form-10 for the product.

65. Can ISO Symbols such as , , , , etc. be incorporated on the labels of registered notified medical devices being imported into India?


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Ans.Yes, the ISO Symbols are acceptable on labels of registered notified medical devices being imported into India.

66. Whether shelf life of the device can be stated on the label instead of date of

manufacture? Ans.Yes

67. What are mandatory addresses on the labels of registered notified medical devices

being imported/ marketed in India as per the Drugs and Cosmetics Act, 1940? Ans.Name and address of Legal Manufacturer, Actual manufacturer and importer as stated in Form-10.

68. All certificates with minimum 6 months validity are being asked as per guidance

document. Can the applicant provide the renewed certificates in case the certificate gets expired during the review process? Ans.As per the Guidance document for Registration/ Re-registration, all certificates with minimum 6 months validity are to be submitted. However, if the applicant has a valid reason for not being able to submit the same within stipulated validity, they can provide an undertaking to the CDSCO stating that fresh certificates will be submitted immediately after expiry of such certificates and such instances will be dealt on a case to case basis as per rationale of reason.

69. If my medical device has an adverse event, do I need to report it to CDSCO? Ans. Yes, To find out more about the adverse event reporting criteria, procedure and timeline, please refer to our website on http://cdsco.nic.in/pharmacovigilance.htm

70. If a recall or corrective action is required for my medical device, do I need to report

it to the CDSCO? Ans.Yes

71. Can import of the medical device with brand namebe done in case the Import

License (Form-10) reflecting the product (medical device) with generic name or vice versa? Ans. No

72. Can an importer import a registered notified medical device having residualshelf

life less than 60 % for Commercial or testing purpose? Ans. No.

73. Can one time permission for import of regulated medical device be granted without

having valid Import Licence in Form-10? Ans. No.

74. What are the regulatory requirements for Import, Manufacture and labeling of

Veterinary medical devices? Ans. Same as devices meant for human beings.


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75. Is there a need to register notified products that are imported and locally processed for 100% export only and which will not be marketed in India? Ans. No, However the importer shall comply with requirements specified by DGFT from time to time.

76. Whether local manufacturer needs to obtain an import license for suture raw

material that is used 100% for own manufacturing of final finished Sutures for which state FDA has already issued a manufacturing license. Ans. Yes.

77. Where can I submit my enquiries related to registration, import and manufacture of medical devices? Ans.All enquiries regarding the submission and approvals can be sent to the Drugs Controller General India ([email protected]) - CDSCO, FDA Bhawan, ITO, Kotla Road, New Delhi - 110002. Phone: 91-11-23236965 / 23236975. Fax: 91-11-23236973.


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An Official Publication of Indian Dental Association, Ludhiana ...

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Transcript of An Official Publication of Indian Dental Association, Ludhiana ...