A clinical trial to study the effects of Fluoride varnish in preventing dental caries in 3-4 years old children in Rohtak district, Haryana

Phase 4

Completed

• Conditions: Dental caries

• Registration Number: CTRI/2015/10/006288
• Lead Sponsor: Postgraduate Institute of Dental Sciences

Brief Summary

This postgraduate thesis study was a randomized, single blind, parallel group trial studying effects of 5% Fluoride varnish on dental caries among 3-4 years old children in Rohtak district, Haryana.The primary outcome measure was net caries increment over the period of 6 months, in which it was observed that net caries increment was significantly lower in the intervention group (0.879 ± 3.270) compared to the control group (2.154 ± 3.051) and  prevented fraction of 59.19% .Unadjusted odds ratio for caries incidence was 1.441 times higher in the control than in the experimental  group.These results corroborate findings from other studies where fluoride varnish was efficacious in preventing dental caries in young children.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-10-15
• Study Completion: 2016-09-25
• Last Update Posted: 2019-11-28

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

• Children in age group of 3-4 years.
• Children present on the day of examination.
• Children with dental caries Children whose parents have given informed consent for fluoride varnish application and follow up for 18 months.
• Children who are permanent residents of that area.

Exclusion Criteria

Children of parents with poor compliance Children absent on the day of examination Un-cooperative child Child with systemic diseases and under long term medication Child with congenital and developmental anomalies Child with allergy to fluoride varnish Children with stomatitis, gingivitis and large open lesion Children with reduced mouth opening.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Net caries increment over the course of study	18 months

Secondary Outcome Measures

Name	Time	Method
Need for dental treatment, the cost of FV treatment, the acceptability of the preventive treatment and any side effects	18 months

Trial Locations

Locations (1)

Postgraduate Institute of Dental Sciences; 🇮🇳 Rohtak, HARYANA, India

Postgraduate Institute of Dental Sciences

🇮🇳Rohtak, HARYANA, India

Dr Mamta Ghanghas

Principal investigator

09416880999

mamtaghanghas@gmail.com