Effect of fluoride varnish when applied on decayed tooth of children of age group 3-5 years

Phase 3

• Conditions: Healthy children having one or more than one decayed/missing/filled tooth

• Registration Number: CTRI/2016/02/006659
• Lead Sponsor: Santosh Kumari Agrawal

Brief Summary

This is a randomized parallel placebo controlled trial conducted to see the effectiveness of fluoride varnish on dental caries among school children of aged 2-5 years. The primary outcome is to see the caries progression by 9months and secondary outcome is to measure the caries incidence.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-10-01
• Last Update Posted: 2016-02-17

Recruitment & Eligibility

• Status: Not Applicable
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Child has decayed/missing/filled surfaces high risk group child has plaque on teeth.

Exclusion Criteria

child has a history of allergic reaction that required hospitalization Presence of fixed orthodontic application Participation in any other clinical study children under 3 years uncooperative child child donot willing to take part in study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary outcome is caries progression by 9 months will be measure by the changes from baseline	after 9 momths
secondary outcome is caries incidence as measure by the proportion of children developing any new dentine caries during the study	after 9 momths

Secondary Outcome Measures

Name	Time	Method
caries incidence as measure by the proportion of children developing any new dentine caries during the study	9monts

Trial Locations

Locations (1)

Government schools of Dharan Nepal; 🇮🇳 Dharan, Nepal, India

Government schools of Dharan Nepal

🇮🇳Dharan, Nepal, India

Dr Santosh Kumari Agrawal

Principal investigator

977-9842082407

ishrita11@gmail.com