DR. neha arun toshniwal, post graduate student, department of periodontics, V. S. Dental college and hospital



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RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES

KARNATAKA, BANGALORE
ANNEXURE II

PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION.





1.



NAME OF THE CANDIDATE AND ADDRESS

(IN BLOCK ADDRESS)




DR. NEHA ARUN TOSHNIWAL,

POST GRADUATE STUDENT,

DEPARTMENT OF PERIODONTICS,

V.S.DENTAL COLLEGE AND HOSPITAL

BANGALORE.

2.

NAME OF THE INSTITUTION


VOKKALIGARA SANGHA DENTAL COLLEGE & HOSPITAL,

BANGALORE.

3.

COURSE OF STUDY AND SUBJECT

MASTER OF DENTAL SURGERY,

PERIODONTICS

4.

DATE OF ADMISSION TO COURSE

31.05.2008

5.

TITLE OF THE TOPIC

COMPARISION OF HEALING RESPONSE OF PERIODONTAL FURCATION DEFECTS FOLLOWING FLAP DEBRIDEMENT SURGERY IN SMOKERS AND NON-SMOKERS-

A CLINICAL AND MICROBIOLOGICAL STUDY.




6) BRIEF RESUME OF THE INTENDED WORK:
6.1 NEED FOR THE STUDY:-
Smoking is one of the most common form of recreational drug abuse. It increases risk for lung cancer, cardiovascular diseases, psychological effects, and has various effects on oral health which include increased risk for oral cancer, white mucosal lesions, periodontitis etc.
Impact of smoking on periodontium includes increased prevalence and severity of attachment loss and increased rate of periodontal destruction and tooth loss. One of the common findings in advanced periodontitis is the spread of inflammation to involve bifurcation and trifurcation of multirooted teeth and prognosis of these teeth is potentially less favorable.[1]
Furcation involvement is more frequently detected in smokers (72%) than non-smokers (36%)[2]. Less favorable response of periodontal tissues to surgical therapy has been observed in smokers.
Therefore the aim of the present study is to investigate the clinical and microbiological outcomes, including the healing response in smokers and non-smokers following conventional flap debridement surgery.
6.2 REVIEW OF LITERATURE:
A study indicated that (1) Flap debridement surgery produced clinically and statistically significant periodontal pocket depth reduction, vertical and horizontal clinical attachment level gain in class I/II molar furcation defects and (2) Cigarette smokers exhibit a less favorable healing outcome following surgery in terms of both vertical and horizontal clinical attachment level gain.[3]
A study indicated that (1) Flap debridement surgery determined a statistically significant pocket depth reduction and clinical attachment level gain in patients with moderate to advanced periodontitis. (2) Smokers exhibited a trend towards less favorable healing response following flap debridement surgery compared to non-smokers, both in terms of pocket depth reduction and clinical attachment level gain; and (3) this trend reached clinical and statistical significance at sites with initial deep pocket depth.[4]
A study demonstrated that a different microflora is associated with healthy and periodontally diseased sites in the same patient population and that these differences can be detected by of a technique which is simple and readily adaptable to a clinical setting for eg. dark field microscopy.[5]
A study demonstrated marked variations of microbiological counts at the different post-operative time points. In the few sites undergoing probing attachment loss, no apparent association between target micro-organisms and periodontal deterioration was observed.[6]
A study demonstrated that the proportions spirochetes with or without motile rods in samples obtained at baseline were shown to be good predictors of periodontal deterioration as determined by number of teeth which were exited for each subject during the course of study. None of the clinical measurements could be used in this predictive capacity.[7]





6.3 OBJECTIVES OF STUDY:

To evaluate the treatment outcomes of periodontal furcation defects following open flap debridement surgery procedure in smokers compared to non-smokers


- Clinically

- Microbiologically.



7) MATERIALS AND METHOD:
7.1 SOURCE OF DATA:
Twenty individuals, ten smokers and ten non-smokers, (age matched) with at least one class I or II furcation involvement in mandibular molars with pocket depth of 5 mm or more will be included in the study. The subjects will consist of both male and female patients reporting to the Department of Periodontics, VSDC & H, Bangalore.

METHOD OF COLLECTION OF DATA:

Patients fulfilling the following inclusion criteria will be included in the study. Smoking status will be assessed by a self reported questionnaire. It will be made clear to all potential subjects that participation will be voluntary. Verbal and written informed consent will be obtained from those who agree to participate.


INCLUSION CRITERIA:


  1. Systemically healthy patients with no contraindication for periodontal surgery.




  1. Patients of either sex with presence of at least one class I or II mandibular molar furcation defect.




  1. Centers for disease control and prevention (CDC) criteria will be used to decide the inclusion of patients in smokers or non-smokers. According to this criteria,

Current smokers are those who smoked 100 or more cigarettes over their lifetime and smoked at the time of interview. Non-smokers are those who have not smoked more than 100 cigarettes in their lifetime.


  1. Patients who are co-operative and able to come for regular follow-up.


EXCLUSION CRITERIA:

  1. Poor systemic health with or without medication.

  2. Pregnant and lactating mothers.

  3. Third molars

  4. Endodontically involved teeth.







  1. Patients showing unacceptable oral hygiene compliance during or after phase 1 therapy.


7.2 METHODOLOGY:
This study will be a parallel design, controlled clinical trial.

All the 20 patients will be delivered full mouth scaling and root planing prior to surgery. There will be at least 3 to 4 weeks elapse from the completion of non-surgical therapy until surgery.


Clinical Parameters:
Following clinical parameters will be recorded at baseline, 12 weeks and 24 weeks.


  1. Bleeding index by Ainamo and Bay(1975)




  1. Plaque index by Silness.P and Loe.H(1964)




  1. Relative attachment level (RAL), periodontal pocket depth(PD) and gingival marginal recession at test sites using Acrylic Occlusal stents.




  1. Horizontal clinical attachment level (h-CAL) using Naber’s probe at test site.


Fabrication of Acrylic stent:
Customized acrylic stents will be prepared on a study model for each patient using self-cure acrylic to fit over the selected teeth. A vertical groove will be made on the stent at the defect site which aids in the probe penetration in the same plane. The stents will be preserved on the study casts for follow-up measurements.

Probing pocket depth and probing attachment level will be recorded by UNC-15 probe with a stent. This will provide a well defined and reproducible clinical measurement in both smokers and non-smokers at test site for each examination time point at baseline, 12 weeks and 24 weeks.


Microbiological procedure:
Subgingival plaque samples will be collected from the selected sites at baseline, 12 weeks & 24 weeks using Gracey curettes.

A slide will be prepared by placing one drop suspension of 0.85% NaCl solution containing 1% gelatin, onto which plaque sample will be dispensed and viewed using Phase contrast Microscopy for the presence of rods, cocci and spirochetes.

To investigate the shift of microflora from gram negative to gram positive, Gram’s staining at baseline, 12 weeks and 24 weeks will be conducted.
Surgical procedure:
Following local anesthesia, open flap debridement at test sites will be done for which intra-crevicular incision will be given. A full thickness mucoperiosteal flap will be raised and root debridement will be done. Sutures will be given.

Patients are required to return for standard supportive and post operative follow-up over the 6 month study interval. All subjects will be on a strict recall schedule following surgery.


Recall examinations and maintenance therapy will be scheduled at 3 month intervals. At each postoperative visit samples for microbiological procedure will be taken and PD, RAL, h-CAL, BOP and PI will be measured.




7.3 DOES THIS STUDY REQUIRE ANY INVESTIGATION OR INTERVENTIONS TO BE CONDUCTED ON PATIENTS OR OTHER HUMAN BEINGS?

- Yes, patients will be advised to get blood investigations done which includes total count, differential count, Hb %, platelet count, bleeding time, clotting time and radiographs.
7.4 HAS ETHICAL CLEARANCE BEEN OBTAINED FROM YOUR INSTITUTION IN CASE OF 7.3?


  • Yes


8) LIST OF REFERENCES:


  1. M.John Novak and Karen F.Novak. Smoking and Periodontal disease. Carranza’s Clinical Periodontology-Tenth edition;251-258.




  1. Marcello Cattabriga, Vinicio Pedrazzolli & Thomas G.Wilson JR. The conservative approach in the treatment of furcation lesions. Periodontology2000, vol. 22; 2000:133-153.




  1. Trombelli L, Cho K-S, Kim C-K, Scabbia A. Impaired healing response of periodontal furcation defects following flap debridement surgery in smokers. A controlled clinical trial. J Clin Periodontol 2003;30:81-87.




  1. Alessandro Scabbia, Kyoo-Sung Cho, Thorarinn J, Sigurdsson, Chong-Kwan Kim, and Leonardo Trombelli. Cigarette smoking negatively affects healing response following flap debridement surgery. J Periodontal 2001;72:43-49.




  1. A. Listgarten and L. Hellden. Relative distribution of bacteria at clinically healthy and periodontally diseased sites in humans. J Clin Periodontal 1978;5;115-132.




  1. Loos B, Claffey N and Egelberg J. Clinical and microbiological effects of root debridement in periodontal furcation pockets. J Clin Periodontol 1988;15:453-463.




  1. M. A. Listgarten and S. Levin. Positive correlation between the proportions of subgingival spirochetes and motile bacteria and susceptibility of human subjects to periodontal deterioration. J Clin Periodontol 1981;8:122-138.





9.

SIGNATURE OF CANDIDATE









10.


REMARKS OF THE GUIDE



11.


NAME AND DESIGNATION OF:



  1. GUIDE



  1. SIGNATURE


  1. CO-GUIDE



  1. SIGNATURE



  1. HEAD OF THE DEPARTMENT


  1. SIGNATURE




DR. VINAYAK.S.GOWDA

ASSOSIATE PROFESSOR

DR. SUSHMA.R. GALGALI

PROFFESSOR AND HOD.




12.



REMARKS OF THE

CHAIRMAN AND PRINCIPAL


SIGNATURE

















CASE HISTORY PROFORMA

DEPARTMENT OF PERIODONTICS

CASE HISTORY
NAME: O.P.NO:
AGE/SEX: DATE:
OCCUPATION:
ADDRESS:
CHIEF COMPLAINT:
HISTORY OF PRESENT ILLNESS:
PAST DENTAL HISTORY:
MEDICAL HISTORY:

B) CLINICAL ASSESSMENT




TOOTH INVOLVED



EXAMINATION TIME



BASELINE

12th week

24th week

1. PLAQUE INDEX











2. BLEEDING INDEX











3. RELATIVE ATTACHMENT

LEVEL










4.HORIZONTAL CLINICAL

ATTACHMENT LEVEL










5.PERIODONTAL POCKET DEPTH











6.GINGIVAL MARGINAL

RECESSION.












PLAQUE INDEX (Silness & Loe, 1964) SCORING CRITERIA :

Plaque scoring will be done on four areas of the tooth, mesiofacial, facial, distofacial and lingual after air drying, using a mouth mirror and explorer.



Score

Criteria

0

The gingival area of the tooth is literally free of plaque. The surface is tested by running a pointed probe across the tooth surface at the entrance of the gingival crevice after the tooth has been dried. If no soft matter adheres to the point of the probe, the area is considered clean.

1


No plaque can be observed in situ by the naked eye. A film of plaque adhering to the free gingival margin and adjacent area of the tooth, which can be recognized only by running the explorer/pointed probe across the tooth surface or by using a disclosing agent.

2


A thin moderate accumulation of soft deposits within the gingival pocket or on the tooth and gingival margin, which can be seen by the naked eye.

3


Abundance of soft matter within the gingival pocket and/or on the tooth surface and gingival margin. The interdental area is stuffed with soft debris.

Plaque score = Sum of scores of all surfaces No of surfaces examined

Suggested nominal scale for patient evaluation :

Rating

Scores

Excellent

0

Good

0.1-0.9

Fair

1.0-1.9

Poor

2.0-3.0

GINGIVAL BLEEDING INDEX (Ainamo & Bay, 1975) SCORING CRITERIA:

Score

Criteria

+

The appearance of bleeding within 10 seconds of probing the gingival crevice gently with a periodontal probe

-

Absence of bleeding

The index value is expressed as the sum of positive score divided by the total number of the gingival margins examined in percentage.

Gingival Bleeding Index Score = Sum of positive scores x 100

No of gingival margins examined


Department Of Periodontics,

V.S Dental College and Hospital, Bangalore
CONSENT FORM

  1. I consent to the recommended procedure (minor surgical procedure) or treatment to be completed by Dr

  2. The procedure or treatment has been described to me.

  3. I have been informed of the purpose of procedure or treatment.

  4. I have been informed of the alternatives to the procedure or treatment.

  5. I understand that following risks may result from the procedure or treatment.




  1. Increased sensitivity

  2. Spacing between teeth

  3. Recession

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

  1. Bleeding from Gums

  2. Mobility of teeth

  3. Bone loss

  4. Loss of teeth




  1. I do/do not consent to the administration of anesthesia.

  2. I understand that the following risk are involved in administrating anesthesia

a) Mild discomfort

  1. Hematoma

  2. Paresthesia

  1. ALL MY QUESTIONS HAVE BEEN SATISFACTORILY ANSWERED.

Signature Date:


Signature of witness Date:




DATA SHEET

OP NO.


1. DEMOGRAPHIC

A. NAME


B. AGE

C. PLACE OF RESIDENCE 1) URBAN 2) RURAL

D. EDUCATION


  1. None

  2. Primary

  3. High School

  4. University

E. EMPLOYMENT STATUS

  1. UNEMPLOYED

  2. EMPLOYED

F. INCOME STATUS

(<20,000)

(20,000 - 40,000) (40,000 - 62,000) (62,000 - 86,000) (86,000 - 5,00,000)



  1. Low

  2. Lower Middle

  3. Upper Middle

  4. High

  5. Above

SMOKING STATUS ASSESSMENT FORM

  1. Do you Smoke? Yes/No

If yes then,

Type l) Cigarette 2) Beedies 3) Chutta 4) Pipe/roll 5) Others

If you smoke cigarette then please answer the following questions,


  1. Age at which you started smoking?

  2. How many cigarettes a day do you smoke?

1) 1-10 2) 11-20 3) 21-30 4) more than 30

4. Number of years of smoking



0) Equal or < 10 years 1) > 10 years
















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