Rajiv gandhi university of health sciences, bangalore, karnataka




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RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES,

BANGALORE, KARNATAKA.
ANNEXURE-II
PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION



1

Name of The Candidate and Address

(in Block Letters)

Dr. SIMPY MITTAL

DEPARTMENT OF PREVENTIVE AND COMMUNITY DENTISTRY,

COLLEGE OF DENTAL SCIENCES,

DAVANGERE-577 004,

KARNATAKA.


2

Name of the Institution

COLLEGE OF DENTAL SCIENCES,

DAVANGERE-577 004,

KARNATAKA.


3

Course of Study and Subject

MASTER OF DENTAL SURGERY (MDS) IN

PREVENTIVE AND COMMUNITY DENTISTRY.




4

Date of Admission to Course



5

Title of the Topic:
COMPARATIVE EFFICACY OF FOUR DIFFERENT DENTAL GELS AND FOUR MOUTHWASHES ON PLAQUE AND GINGIVAL SCORES: A SIX WEEK CLINICAL TRIAL.









6.

BRIEF RESUME OF THE INTENDED WORK





    1. Need for the study:

Gingivitis is a chronic inflammatory process limited to the gingiva and without either attachment or alveolar bone loss. It is one of the most frequent oral diseases, affecting more than 90% of the population, regardless of age, sex or race. The earliest clinical sign is the bleeding caused by a vasodilator effect caused by an inflammatory response. The prevention of gingivitis by daily and effective supragingival plaque control using tooth brushing and dental floss is necessary to arrest a possible progression to periodontitis.

Although mechanical plaque control methods have the potential to maintain adequate levels of oral hygiene, clinical experience and population-based studies have shown that such methods are not being employed as accurately as they should by a large number of people. Therefore, several chemotherapeutic agents such as triclosan, essential oils and chlorhexidine have been developed to control bacterial plaque, aiming at improving the efficacy of daily hygiene control measures. 1 Chlorhexidine is a cationic bisbiguanide, which has been widely used as an antibacterial agent against the microbes responsible for oral infections.3

The interest in plants with antibacterial and anti-inflammatory activity has increased as a consequence of current problems associated with the wide-scale misuse of antibiotics that induced microbial drug resistance.1



Azadiratica indica (neem) has been used in the folklores systems of medicine since ages as an agent for keeping teeth and gums healthy. The antibacterial activity of neem has been evaluated and published, including its therapeutic use in periodontal disorders.3

Anti bacterial property of Punica granatum have been widely investigated. Punica granatum L. gel has shown inhibitory activity on the adherence of different bacterial strains and one yeast commonly found in the oral cavity.4

The gum of Acacia arabica (Acacia nilotica)was known to several communities by its long-lasting freshness and cleansing property in the mouth.2






7.

Methods of delivering drugs to the oral cavity for oral infectious conditions are not fully developed. One reason is the difficulty in placing an adequate, non-toxic amount of a drug at the intended site of action for a sufficiently long period. Consequently, drugs have been incorporated in high

viscous gel formulations to prolong the release time, reduce the frequency of application and total dose of the drug.3

6.2 Review of literature:

A crossover, double-blind study was carried out on 23 volunteers to evaluate the antiplaque and antigingivitis effects of a gel containing 10% Punica granatum Linn extract. The use of the gel showed reduced plaque and gingival bleeding scores, though the results were not statistically significant.1


A study was conducted on 20 dental students to evaluate the effect of Acacia arabica gum on plaque and gingivitis and compare it with sugar-free gum. The study showed that acacia gum has the potential to inhibit early plaque formation. 2
A study conducted on 48 adult subjects to evaluate the clinical efficacy of two gel formulations containing chlorhexidine gluconate and neem extract with a commercially available chlorhexidine gluconate mouthwash showed that neem extract gel significantly reduced plaque and gingival scores when compared with the control group and chlorhexidine gluconate gel reduced the plaque and gingival scores significantly more than the chlorhexidine gluconate mouthwash.3
A study conducted to investigate the antimicrobial effect of a Punica granatum linn (pomegranate) phytotherapeutic gel and miconazole (Daktarin®oral gel) against three standard streptococci strains (mutans ATCC 25175, sanguis ATCC 10577 and mitis ATCC 9811), S.mutans clinically isolated and Candida albicans either alone or in association. The Punica gel had a greater efficiency in inhibiting microbial adherence than the miconazole. The results of this study suggest that this phytotherapeutic agent might be used in the control of adherence of different microorganisms in the oral cavity.4
A study was conducted to examine the inhibitory effects of aqueous extracts derived from the bark-containing sticks (Neem stick) of Azadirachta indica upon bacterial aggregation, growth, adhesion to hydroxyapatite, and production of insoluble glucan, which may affect in vitro plaque formation. It was concluded that the Neem plant contains components which can inhibit some oral streptococci virulence factors which influence plaque formation.5

6.3 Objectives of the study:


  1. To evaluate the clinical efficacy of four gel formulations containing chlorhexidine gluconate, neem extract, Acacia nilotica extract and Punica granatum extract in reducing plaque and gingival scores.

  2. To evaluate the clinical efficacy of four mouthwash formulations containing chlorhexidine gluconate, neem extract, Acacia nilotica extract and Punica granatum extract in reducing plaque and gingival scores.

  3. To compare the clinical efficacy of the gel formulation with the mouthwash formulation.

MATERIALS AND METHODS
7.1 Source of data:
90 adult subjects (35 – 44 years) will be included. School teachers fulfilling the inclusion criteria will be selected randomly from schools in Davangere city, Karnataka.

7.2 Study Design:
A randomized controlled clinical trial will be conducted.
Inclusion Criteria:
Subjects with

1. At least 20 intact natural teeth.

2. Patients co-operative and willing to participate in the study.
Exclusion Criteria :
1. Any oral soft tissue pathology.

2. Gross dental caries.

3. History of allergy to oral care products.

4. Subjects with any systemic disorders.

5. Pregnancy.








Indices used:
1. Plaque Index (Silness H. and Loe J.)

2. Gingival Index (Loe J. and Silness H.)


Sample Size & Design:
90 adult subjects in the age group 35-44 years will be considered as the study population. They will be randomly divided into 9 groups with 10 participants in each group.

The nine study groups are,

Group I - Placebo gel

Group II - Chlorhexidine gluconate mouthwash

Group III - Neem extract mouthwash

Group IV - Punica granatum mouthwash

Group V - Acacia nilotica mouthwash

Group VI -Chlorhexidine gluconate gel

Group V II - Neem extract gel

Group VIII -Punica granatum extract gel

Group IX - Acacia nilotica extract gel
Preparation Of The Test Gels:
Mucoadhesive polymer will be used as the vehicle. The concentration of polymer will be varied accordingly to obtain the gel formulation with uniform viscosity which would be suitable for easy oral application.

Neem extract will be prepared by macerating 20g of dry powder of neem leaves with 100ml of 70% w/v ethyl alcohol for a week. The extract will be then filtered through Whatman no.1 filter paper.



Punica granatum extract will be prepared after separating the peel from the mesocarp, drying in an incubator at 33°C for 3 days and will be powdered.

An infusion will be prepared with powdered material at a ratio of 100 g powder to 1000 mL distilled water, cooled at room temperature and filtered.



Acacia nilotica bark will be obtained from the tree and dried in sun for 3 days and powdered. An infusion will be prepared with powdered material at a ratio of 100 g powder to 1000 mL distilled water, cooled at room temperature and filtered.

Gel formulation will consist of the plant extract, gel base, sweetener, preservative, flavouring agent and edible colour.


Method of Examination:
Purpose of the study will be explained to the study subjects and demographic details will be taken in a proforma along with the consent from all the subjects.

The clinical examination will be conducted in the Department of Preventive and Community Dentistry, College of Dental Sciences, Davangere.

Baseline examinations will be done by a single examiner and scores of Gingival index (Loe H. and Silness J.) and Plaque index (Silness J. and Loe H.) will be recorded.

All the subjects will be provided with their assigned products and instructed to use them twice daily. Subjects in the mouthwash group will be instructed to use 10 ml for 30 seconds twice daily. Subjects in the gel groups will be instructed to take the gel on their index finger and apply thoroughly in the oral cavity.

All the subjects will be instructed to follow their routine oral hygiene practices along with the assigned products.

At 3 and 6 weeks, assessment will be made by the same examiner using the same indices.




Instruments and materials:
Mouth mirror

Explorer


Tweezers

Kidney tray

Enamel bowl

Gloves


Mouth mask

Cotton


Korsolex disinfectant solution.
Statistical analysis:

One way analysis of variance (ANOVA) will be used for multiple group comparisons followed by post-hoc tests for pair wise assessment.


Duration of study: 1 year.
7.3 Does the study require any investigation (or) intervention to be conducted on patients (or) other humans (or) animals? If so please describe briefly :

Yes.


Baseline examinations will be done by a single examiner and scores of Gingival index (Loe H. and Silness J.) and Plaque index (Silness J. and Loe H.) will be recorded.

All the subjects will be provided with their assigned products and instructed to use them twice daily. Subjects in the mouthwash group will be instructed to use 10 ml for 30 seconds twice daily. Subjects in the gel groups will be instructed to take the gel on their index finger and apply thoroughly in the oral cavity.

All the subjects will be instructed to follow their routine oral hygiene practices along with the assigned products.

At 3 and 6 weeks, assessment will be made by the same examiner using the same indices.



7.4 Has ethical clearance been obtained from your institution?
Yes.







LIST OF REFERENCES


  1. Salgado A.D.Y., Maia J.L., Pereira S.L., Gomes de Lemos T.L., Mota O.M. Antiplaque and antigingivitis effects of a gel containing Punica granatum Linn extract. A double-blind clinical study in humans.

J App Oral Sci 2006;14(3)


  1. Gazi Mohamed I. The finding of antiplaque features in Acacia arabica type of chewing gum.

J Clin Periodontol 1991;18:75-77


  1. Pai M.R., Acharya L.D., Udupa N. The effect of two different dental gels and a mouthwash on plaque and gingival scores: a six-week clinical study.

Int Dent J 2004;54:219-223


  1. Vasconcelos L.C., Sampaio F.C., Sampaio M.C.C., Pereira M.S.S, Higino J.S., Peixoto M.H.P. Minimum inhibitory concentration of adherence of Punica granatum Linn (pomegranate) gel against S.mutans, S.mitis and C.albicans. Braz Dent J 2006;17(3):223-227




  1. Wolinsky L.E., Mania S., Nachnani S., Ling S. The inhibiting effect of aqueous Azadirachta indica (Neem) extract upon bacterial properties influencing in vitro plaque formation. J Dent Res 1996; 75:816-822.































































SIGNATURE OF THE

CANDIDATE


( Dr. SIMPY MITTAL )




REMARKS OF THE GUIDE








NAME AND DESIGNATION OF

(IN BLOCK LETTERS)

11.1 GUIDE


Dr. CHANDU G.N.,M.D.S.,

PROFESSOR AND HEAD OF THE DEPARTMENT,

DEPARTMENT OF PREVENTIVE AND COMMUNITY DENTISTRY,

COLLEGE OF DENTAL SCIENCES, DAVANGERE – 577004.







11.2 SIGNATURE






11.3 Co-GUIDE (IF ANY)






11.4 SIGNATURE






11.5 HEAD OF THE DEPARTMENT


Dr. CHANDU G.N., M.D.S.,

PROFESSOR AND HEAD OF THE DEPARTMENT,

DEPARTMENT OF PREVENTIVE AND COMMUNITY DENTISTRY,

COLLEGE OF DENTAL SCIENCES, DAVANGERE – 577004.







11.6 SIGNATURE




12

12.1 REMARKS OF THE


CHAIRMAN AND THE PRINCIPAL
12.2 SIGNATURE


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