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 Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- 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.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Coin toss, Lottery, toss of dice, shuffling cards etc
- Masking
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
Eligibility Criteria
- Ages
- 12.00 Year(s) to 15.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •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.
- •Subjects whose parents gave informed consent.
Exclusion Criteria
- •Subjects using antibiotics, antiseptic mouthwashes for at least 3 months prior to the study and during the entire period of the study.
- •Subjects undergoing any dental treatment, orthodontic treatment, or with extensive intra-oral prosthesis or any developmental defects.
Outcomes
Primary Outcomes
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 Frame: 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 Outcomes
No secondary outcomes reported