A clinical trial to compare effect of licorice, fluoride and combination of both on early stage of tooth decay in 3-4 year old preschool children.

Phase 3

Completed

• Conditions: initial dental caries

• Registration Number: CTRI/2015/10/006305
• Lead Sponsor: Dr Roopali Sankeshwari

Brief Summary

This study is a randomized,  single blind parallel group trial comparing the effectiveness of Licorice varnish, fluoride varnish and the combination of both on initial lesions of Early childhood caries in 3-4 year old preschool children of Belgaum city. The primary outcome measures will be Remineralization of initial dental carious lesions and change in Salivary *Streptococcus mutans* count after 12 months. Research hypothesis would be that the effect of licorice varnish on initial carious lesions would be non inferior to the effect of fluoride varnish. Varnishes would be applied on randomly selected preschool children at baseline,3rd , 6th,9th month respectively. Diagnodent instrument would be used to measure the extent of changes in the demineralized lesion after the intervention.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-12-15
• Last Update Posted: 2023-01-20

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 195

Inclusion Criteria

• •Child with at least one initial caries lesion as per Nyvad classification.
• •Children with dental caries experience (dmft score) in the range of 3-6.

Exclusion Criteria

• •Children with any GIC restorations, pit and fissure sealants.
• •Developmental alterations like hypoplasia or fluorosis.
• •Use of orthodontic device or appliance.
• •Being under medical treatment or taking any kind of medication and •Parents not willing to give consent.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
•Remineralization of initial caries – Minimum 4 points change in diagnodent score	•at the end of 1 year
•Change in salivary Streptococcus mutans count before and after the intervention at the end of 1 year.	•at the end of 1 year

Trial Locations

Locations (1)

Randomly selected private and public preschools of Belgaum; 🇮🇳 Belgaum, KARNATAKA, India

Randomly selected private and public preschools of Belgaum

🇮🇳Belgaum, KARNATAKA, India

Dr Roopali Sankeshwari

Principal investigator

9844837197

docrups@gmail.com