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CTRI Number  CTRI/2014/01/004274 [Registered on: 02/01/2014] Trial Registered Retrospectively
Last Modified On: 02/01/2014
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Preventive
Dentistry 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Comparision of anti-bactrial action of Chlorhexidine – Thymol and fluoride varnishes 
Scientific Title of Study   Effectiveness of Chlorhexidine-Thymol and Fluoride varnish on salivary streptococcus mutans and lactobacillus count among 12-15 years old children in rural school around Belgaum city- A Randomized field trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
Nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Pratibha A Patil 
Designation  Lecturer 
Affiliation  KLE VK Institution of Dental science 
Address  MIG-11, Sidha nivas Mahantesh nagar
KLE Dental College Nehru nagar
Belgaum
KARNATAKA
590016
India 
Phone  9448358235  
Fax  2470640  
Email  drprati07@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Anil V Ankola  
Designation  Prof & HOD 
Affiliation  KLE VK Institution of Dental science 
Address  H No18, Kamadhenu, 1st Cross Adarsh Nagar M Vadagoan
KLE Dental College Nehru nagar
Belgaum
KARNATAKA
590016
India 
Phone  9343434455  
Fax  2470640  
Email  drankola@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr Pratibha A Patil 
Designation  Lecturer 
Affiliation  KLE VK Institution of Dental science 
Address  MIG-11, Sidha nivas Mahantesh nagar
KLE Dental College Nehru nagar
Belgaum
KARNATAKA
590016
India 
Phone  9448358235  
Fax  2470640  
Email  drprati07@gmail.com  
 
Source of Monetary or Material Support  
KLE VK Institute of Dental Science 
 
Primary Sponsor  
Name  KLE VK Institute of Dental Science 
Address  KLE VK Institute of Dental Science Nehru Nagar Belgaum.  
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Pratibha Patil  Government schools around rural areas of Belgaum city   Rural Governement Schools of Belgaum taluk. List of Schools in rural areas where the study was conducted. South zone:Kakati, Butharamhatti. North zone:Phirenwadi, Desur
Belgaum
KARNATAKA 		 9448355235
2470640
drprati07@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Research and ethical comittee.KLE VK Institute of Dental Science, Belgaum  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  12-15 years old healthy children  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  1.Fluoride varnish   1. DURAPHAT VARNISH The active ingredient is • Sodium fluoride 5% (50,000 ppm sodium fluoride) The inactive ingredients are • Sodium saccharin – used as sweetener • Flavors – various tastes • Bees wax and ethanol – forms gel type structure to stabilize sodium ions • Shellac and mastic – provides a flexible , permeable hard surface that prevents the varnish dissolving quickly in saliva • Flow enhancers – some varnishes contain kolophonium to help the varnish flow. Dose: 0.5ml of Varnish was applied to the teeth with the help of custom made cotton pellets. Frequency: Varnish application was performed quadrant wise sequentially starting from the lower arches and then continued to the upper arch. This procedure was repeated, and total application was two times a month(once in 15 days). Total study period was9 months Route: Varnish was applied on all the teeth quadrant wise and was allowed to dry for one minute.  
Comparator Agent  2.CHLORHEXIDINE-THYMOL VARNISH  2. CERVITEC: CHLORHEXIDINE-THYMOL VARNISH The active ingredient is • Chlorhexidine diacetate -1% • Thymol – 1% The inactive ingredient is • Excipients -- Vinyl acetate co-polymer and acrylate co-polymer-8% • Solvent -- Ethanol, water -90% Dose: 0.5ml of Varnish was applied to the teeth with the help of custom made cotton pellets. Frequency: Varnish application was performed quadrant wise sequentially starting from the lower arches and then continued to the upper arch. This procedure was repeated, and total application was two times a month(once in 15 days). Total study period was9 months Route: Varnish was applied on all the teeth quadrant wise and was allowed to dry for one minute.  
Comparator Agent  Saline  Its a control. Dose: Saline was applied to the teeth with the help of custom made cotton pellets. Frequency: Saline application was performed quadrant wise sequentially starting from the lower arches and then continued to the upper arch. This procedure was repeated, and total application was two times a month(once in 15 days). Total study period was9 months Route: Saline was applied on all the teeth quadrant wise and was allowed to dry for one minute.  
 
Inclusion Criteria  
Age From  12.00 Year(s)
Age To  15.00 Year(s)
Gender  Both 
Details  1)Subjects with permanent dentition were selected
2)Subjects who were free from systemic disease
3)DMFT was score should be equal to or more than three.
4)Subjects whose parents gave informed consent.
 
 
ExclusionCriteria 
Details  1)Subjects using antibiotics, antiseptic mouthwashes for at least 3 months prior to the study and during the entire period of the study.
2) Subjects undergoing any dental treatment, orthodontic treatment, or with extensive intra-oral prosthesis or any developmental defects.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded 
Primary Outcome  
Outcome  TimePoints 
The main finding of this study was that no statistically significant difference (p0.05) was found in the antibacterial effect between the Chlorhexidine-thymol and fluoride varnishes.  Time point: After application of varnish, Post intervention saliva collection was done at time intervals of 1 week, 1month, 3 months and 6 months. Total study period was 9 months.  
 
Secondary Outcome  
Outcome  TimePoints 
Nil  Nil 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   01/06/2009 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Under process 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

The present study was a triple blind, randomized controlled field trial undertaken to compare the antimicrobial effect of a fluoride varnish and chlorhexidine-thymol varnish applied topically twice in a month in a sample of 90 children aged 12-15 year old government school children of Belgaum city. The children were then divided randomly into three groups: Group-I- Fluoride varnish, Group-II- Chlorhexidine-thymol varnish and Group-III- Control group

 

The study was divided into five phases. At baseline oral prophylaxis was done for all the 90 subjects. Baseline saliva samples were collected and microbial analysis was done. Varnish application was performed quadrant wise sequentially for all the teeth according to the manufacturer’s instructions. This application procedure was repeated in all the three groups. The saliva samples for counting Streptococcus Mutans and Lactobacillus was collected on 5 occasions i.e. before the application of varnishes-baseline, 1 week after the varnish application, one month, three months and at the end of six months after varnish application.

The data obtained was compiled, tabulated and subjected to statistical analysis using one way ANOVA and Wilcoxon’s signed rank test.

In the present study Fluoride varnish and Chlorhexidine-thymol varnish were equally effective in reducing the S mutans count up to 3 month significantly. Later though there was microbial reduction in either of the groups but was not statistically significant .The antibacterial effect of Fluoride was better on Lactobacillus as there was significant reduction in Lactobacillus count up to 1 month as compared to Chlorhexidine-thymol group. In the end of 6 months both the varnish were equally effective in their antibacterial effect against S mutans and fluoride was more effective in reduction of Lactobacillus than does Chlorhexidine-thymol varnish.

The main finding of this study was that no statistically significant difference (p>0.05) was found in antibacterial effect between the Chlorhexidine-thymol and fluoride varnish groups at 6 months. The Chlorhexidine-thymol and fluoride varnish groups showed a statistically significant difference (p<0.05) antibacterial effect when compared individually with the placebo varnish.

Thus both fluoride and Chlorhexidine-thymol varnishes are equally effective in reducing the cariogenic bacteria but these approaches should not be provided in isolation and should be a part and parcel of an integrated oral health package that consists of health educational activities, plaque control and other preventive and oral health promotional measures.

 
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