Effect of Chlorhexidine-Fluoride gel and fluoride varnish on active caries among 9-12 year old children in Bangalore city: A comparative study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 163
- Locations
- 1
- Primary Endpoint
- Progression of active caries lesions
Study Overview
Brief Summary
A Randomized controlled trial was done to assessthe effect of Chlorhexidine-Fluoride gel and Fluoride varnish on active cariesamong 9-12 year old school children from 8 schools of Bangalore city. Childrenwere randomly allocated to 3groups i.e Chlorhexidine-fluoride gel group,profluoride varnish group and control group. Children who fulfilled theeligibility criteria were chosen. At the baseline, the children underwent oralprophylaxis and cavitated lesions were restored with Type II GIC as needed. Activeenamel caries were recorded using Nyvad’s Colleagues criteria (1999).Supervised tooth brushing was performed weekly thrice forChlorhexidine-Fluoride gel group. Profluoride Varnish application was done atBaseline, 6th month and 12th month and No interventionwas done for control group. The effect of chlorhexidine-fluoirde varnish wasevaluated at 6, 12 and 15 months.
Study Design
- Study Type
- Interventional
- Allocation
- Coin toss, Lottery, toss of dice, shuffling cards etc
- Masking
- Participant and Outcome Assessor Blinded
Eligibility Criteria
- Ages
- 9.00 Year(s) to 12.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Children of age 9-12 years Children free of any systemic diseases Children whose parents give consent for the procedures School children with active intact caries according to nyvad criteria.
Exclusion Criteria
- •Children with multiple lesions on the same tooth Children with any systemic diseases and who were taking medication for any illness.
Outcomes
Primary Outcomes
Progression of active caries lesions
Time Frame: 6th month, 12th month and 15th month
Secondary Outcomes
- Not applicable(Not applicable)