CERTIFICATE

This is to certify that Dr. PATHAK TUSHAR SAKAL

is a Post–Graduate (MDS) student in the Department of Periodontics,

admitted to this course during the academic year 2008-2009.

He has proposed the study topic titled- “A Comparative clinical evaluation of subgingivally delivered 0.5% Azithromycin gel and 2 mg Tetracycline hydrochloride fibres in the treatment of chronic periodontitis” to carry on dissertation work. The Ethical Committee has critically analysed the methodology, implications and expected complications of the study. It has been made mandatory to obtain a written informed consent from patients who volunteer to be included in the study. It necessitates the conduct of the study under the strict supervision and guidance of the Head of the Department / Post-Graduate Guide.

The Ethical Committee is of the conscientious opinion that the proposed study can be conducted without any legal, moral or ethical encumbrances.

MR GUNDU RAO MR VENUGOPAL DR H N SHAMA RAO

Founder-Trustee Principal Principal

Sri Ramanashree M S Ramaiah Chairman

Free Clinic LawCollege Ethical Committee

Malleshwaram Legal Member M S Ramaiah

Social Worker DentalCollege

Bangalore

RAJIVGANDHIUNIVERSITY OF HEALTH SCIENCES,

KARNATAKA, BANGALORE

ANNEXURE II

PROFORMA FOR REGISTRATION OF SUBJECT FOR DISSERTATION

1. / Name of the candidate and address
(In block letters) / DR. TUSHAR S. PATHAK.
G-7,C-WING, TRI-BHUVAN
CHS., NEAR HOLYCROSSSCHOOL, KARNIK ROAD,
KALYAN.(W)- 421301.
2. / Name of the institution / M.S.RAMAIAHDENTALCOLLEGE & HOSPITAL,
BANGALORE- 54.
3. / Course of the study and subject / Master of Dental Surgery (M.D.S.)
Department of Periodontics
4. / Date of admission to course / 24/04/2008
5. / Title of the topic
A COMPARATIVE CLINICAL EVALUATION OF SUBGINGIVALLY DELIVERED 0.5% AZITHROMYCIN GEL AND 2mg TETRACYCLINE HYDROCHLORIDE FIBRES IN THE TREATMENT OF CHRONIC PERIODONTITIS.

6. BRIEF RESUME OF THE INTENDED WORK:

6.1 NEED FOR THE STUDY :

Periodontitis is a multifactorial disease in which bacteria plays an essential role, the control of its prevalence and progression requires a reduction of subgingival microbial plaque mass or atleast a suppression of periodontopathic bacteria.

Local delivery of anti – microbials in sustained or controlled delivery systems are used to enhance the effect of non-surgical periodontal therapy; it might be possible to achieve gingival health without the need for invasive techniques with the use of local drug delivery systems.

Local application of antimicrobials could reduce the risk of adverse events associated with systemic antimicrobials, including the development of bacterial resistance.

It has been well established that cause related therapy alongwith tetracycline fibres gave beneficial results in the treatment of periodontitis.

Various studies have found that scaling and root planing with adjunctive use of systemic azithromycin demonsrated improvement in clinical parameters.

Keeping the above fact in mind, the present study is designed to investigate and compare the effectiveness of subgingivally delivered antimicrobial bio-absorbable controlled release 0.5% azithromycin gel and 2mg tetracycline hydrochloride fibres as an adjunct to scaling and root planing in the treatment of chronic periodontitis.

6.2 REVIEW OF LITERATURE:

A comparative study of scaling and root planing plus 0.5% azithromycin gel against scaling and root planing alone was done and authors found more favourable results with adjunctive use of 0.5% azithromycin gel as a controlled drug delivery system enhanced the clinical and microbiological results as shown by the intergroup comparison after three months..1

A study was done in 34 subjects with severe chronic periodontitis. The subjects of the test group had azithromycin three days before full mouth scaling and root planing as against the control group who underwent scaling and root planing directly. It was shown that full mouth scaling and root planing using systemically administered azithromycin was a clinically and bacteriologically useful basic periodontal treatment for severe chronic periodontitits.2

Thirty four patients with periodontitis were prescribed azithromycin 500mg systemically. During this 14 day study, clinical and microbiologic parameters significantly improved after administration of azithromycin and it was detectable in inflamed periodontal tissues for more than 14 days3.

Another study which included 79 patients with four pockets more than or equal to 5mm and bleeding on probing and/or suppuration were randomized into four treatment groups which included ; scaling and root planing alone or in conjunction with the application of 25% tetracycline fibers (19 patients) or 2% minocycline gel ((21 patients) or 25% metronidazole gel (19 patients). Clinical measurements were taken at baseline,6 weeks,3 months and 6 months after anti- microbial application. Out of the four groups, treatment regimen of scaling and root planing plus tetracycline fibre placement gave the greatest reduction in the probing depths over the six months after treatment4.

A total of 113 patients receiving regular supportive periodontal therapy were treated with whole mouth scaling and root planing. Two non –adjacent sites in separate quadrants were selected and were randomly assigned to one of the two treatment groups i.e scaling and root planing alone and scaling and root planing plus tetracycline fibres and the measurements were made at 1,3 and 6 months. At 6 months, tetracycline fibre therapy was significantly better in promoting clinical attachment gain than scaling and root planing alone5.

.

6.3 OBJECTIVES OF THE STUDY:

1.To evaluate the clinical effects of subgingivally delivered antimicrobial bio-absorbable controlled release 0.5% azithromycin gel as an adjunct to scaling and root planing in a randomized split-mouth clinical study.

2.To compare the clinical parameters of subgingivally delivered antimicrobial bio-absorbable controlled release 0.5% azithromycin gel and 2mg tetracycline hydrochloride fibres as an adjunctive to initial periodontal therapy in a randomized split mouth clinical study.

  1. MATERIALS AND METHODS:

7.1 SOURCE OF DATA:

A total of 15 to 20 patients attending the Department of Periodontics, M.S.RamaiahDentalCollege and Hospital, Bangalore will be selected. This is a single center randomized clinical trial study.

INCLUSION CRITERIA:

  • Patients with age group between 35-60yrs
  • Systemically healthy patients having atleast 4 periodontal pockets with probing depth ranging between 5-7mm.
  • Patients who have not undergone any type of regenerative periodontal therapy 6 months prior to the initial examination.
  • Patients without any antibiotic treatment in last 6 months.

EXCLUSION CRITERIA:

  • Patients with known or suspected allergy to the macrolide group or tetracyclines which is prescribed in this study.
  • Patients having periodontal pockets less than 5mm after initial prophylaxis.
  • Patients who are medically compromised.
  • Pregnant or lactating women were excluded.
  • Patients with smoking habit.
  • Sites with overhanging restoration.

7.2 METHOD OF COLLECTING DATA

  • Detailed case history of the patients will be recorded.
  • Patient’s consent will be taken.
  • Occlusal stents will be fabricated for standardization of clinical measurements and used as a FIXED REFERENCE POINT (FRP).
  • All measurements will be taken using UNC-15 probe (Hu Friedy’s).
  • One week prior to baseline measurements all patient will receive oral prophylaxis and oral hygiene instructions.
  • DRUGS USED IN THE STUDY
  1. AZITHROMYCIN 0.5% gel :

Biochemical solvent : N-methyl-2-pyrrolodinone.

Vehicle : Copolymer ( poly lactic-co-glycolic acid ).

(Ratio of solvent:vehicle is 3:1).

. 2. TETRACYCLINE 2mg :

Commercially available 25 mg of pure fibrillar collagen containing approximately 2 mg of evenly impregnated tetracycline hydrochloride.

Clinical parameters which would be assessed are:

  • Gingival index (Loe & Silness 1963).
  • Plaque index (Silness & Loe 1964)
  • Probing depth.
  • Clinical attachment level.
  • Experimental sites:A. SCALING AND ROOT PLANING [SRP] + subgingivally delivered 0.5% azithromycin gel in to periodontal pockets.
  • Experimental sites:B. SCALING AND ROOT PLANING + subgingivally delivered2mg tetracycline hydrochloride fibres into periodontal pockets..

Parameters for comparison:

  • Gingival Index
  • Plaque Index
  • Probing Depth (FRP to BOP –FRP to GM)
  • Clinical Attachment Level (FRP to BOP – FRP to CEJ)
  • Gingival Margin Position (FRP to CEJ – FRP to GM)

FRP-Fixed reference point.

BOP-Base of the pocket.

GM-Gingival margin

CEJ-Cemento enamel junction

FOLLOW UP:

Follow up will be done at baseline, 3 and 6 months respectively for measuring the clinical parameters during the period of 18 months.

STATISTICAL TESTS:

All the parameters will be evaluated at baseline, 3 and 6 months period and compared with base line data using student t test.

7.3 Does the study require any investigation or intervention to be conducted on patients or other human or animal?

YES.

Local Delivery Antimicrobial 0.5% AZITHROMYCIN GEL& 2 mg TETRACYCLINE HYDROCHLORIDE FIBRESwill be used in the study.

8. LIST OF REFERENCES:

1 AR Pradeep ; Clinical & microbiologic effects of subgingivally delivered 0.5 % azithromycin in the treatment of chronic periodontitis; J Periodontol 2008;79;2125-35.

2. Kazuhiro Gomi ; Effects of full mouth scaling and root planing in conjunction with systemically administered azithromycin;J Periodontol 2007;78;422-29.

3. Kazuhiro Gomi ; Drug concentration in inflamed periodontal tissues after systemically administered azithromycin;J Periodontol 2007;78;918-23.

4. DF Kinane & M Radvar; A six month comparision of 3 periodontal local antimicrobial therapies in persistent periodontal pockets;J Periodontol 1999;70;1-7.

5. Newman ; A six month multicentre evaluation of adjunctive tetracycline fibers therapy used in conjunction with scaling and root planing in maintenance patients : clinical results;J Periodontol 1994;65;685-91.

M.S.RAMAIAHDENTALCOLLEGE AND HOSPITAL, BANGALORE

DEPARTMENT OF PERIODONTICS

PROFORMA

NAME OF THE PATIENT: AGE: SEX: M/F

O.P NO:

OCCUPATION:

ADDRESS & PHONE NO:

SITES SELECTED FOR THE STUDY:

CONTOL SITE/ EXPERIMENTAL SITE

MEASUREMENTS (in mm)

Sr. no. / MEASUREMENTS / BASELINE / 3 MONTHS / 6 MONTHS
1 / Plaque index (total score)
2 / Gingival index (total score)
3 / Pocket depth :
FRP to BOP – FRP to GM
4 / Clinical attachment level:
FRP to BOP- FRP to CEJ
5 / Gingival margin position
(FRP) to(GM)

FRP – Fixed reference point. GM – Gingival margin

BOP – Base of the pocket. CEJ – Cemento enamel junction.

CONSENT FORM

  1. I consent to the recommended procedure or treatment ……………………………………………………………………………………………………………………………………………………………… to be completed by Dr. ______
  1. The procedure(s) or treatment(s) have been described to me.
  1. I have been informed of the purpose of the procedure or treatment.
  1. I have been informed of the alternatives to the procedure or treatment.
  1. I understand that the following risk(s) may result from the procedure or treatment:

………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………

  1. I understand that the following risk(s) may occur if the procedure or treatment is not completed:

………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………

  1. I do – do not – consider to the administration of anesthetic.

a)I understand that the following risks are involved in administering anesthesia:

………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………

b)The following alternatives to anesthesia were described:

………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………

All my questions have been satisfactorily answered.

Signature: ______

Date

Representative: ______

Date

Signature of Witness: ______

Date

9. / Signature of candidate:
10. / Remarks of guide: / SATISFACTORY.
11. / Name and Designation of
(in block letters)
11.1 Guide: / Dr. ASHWINI.S (READER)
11.2 Signature:
11.3 Co-guide (if any):
11.4 Signature:
11.5 Head Of Department: / Dr. HEMA SESHAN (PROFESSOR & HOD)
11.6 Signature:
12. / 12.1 Remarks of the Chairman & Principal:
12.2 Signature: