Efficacy and Safety Evaluation of Anti-Caries Varnish

Dental Caries in Children Clinical Trial

Official title: Phase 2 Efficacy & Safety Evaluation of Advantage Anti-Caries Varnish for Primary Prevention

Status Active, not recruiting

Clinical Trial Summary

The purpose of the study is to determine the efficacy & safety of Advantage Anti-Caries Varnish for primary prevention. The objectives are:

1) To determine if Advantage Anti-Caries Varnish (test varnish) is superior to an active control varnish (5% Sodium Fluoride, no Povidone-Iodine) in the prevention of caries lesions in the primary dentition. Specifically, prevention of caries lesions in primary teeth that either are sound, have only d1 (white spots) lesions or unerupted at baseline; and 2) To document the safety of the test varnish.

Clinical Trial Description

This is a single center randomized, double-blind, placebo-controlled, parallel-group trial. The treatment group will be exposed at baseline and once every three to four months after baseline for a maximum period of 24 months. The control group will be exposed to the control varnish in the same manner. 254 subjects will be enrolled. Half will be randomized to each arm. Subjects will be 10-20 mo of age and in good health. Children attending Maternal and Child Health (MCH) Immunization and Well Child programs in Pohnpei State will be enrolled. Primary Outcome Variables: 1) Surface-level dental caries lesions (d2-4mfs) at 24 months post baseline; 2) Presence/Absence of dental caries lesions (d2-4mfs >0) at 12 months post baseline. Secondary Outcome Variable: Adverse Events ;

Related Conditions & MeSH terms

• Dental Caries
• Dental Caries in Children

• NCT number: NCT04947527
• Study type: Interventional
• Source: Advantage Silver Dental Arrest, LLC
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: June 4, 2022
• Completion date: December 1, 2024