drugset / Trial / NCT04947527

Efficacy and Safety Evaluation of Anti-Caries Varnish

NCT04947527

Phase 2 Completed 274 enrolled Advantage Silver Dental Arrest, LLC
RandomizedParallel-groupQuadruple-blindPrevention

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.

Timeline

Start
2022-06-04
Primary completion
2024-06-19
Completion
2024-08-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Povidone-Iodine Other / unclassified 10 % Topical
Comparator sodium fluoride Unknown 5 % Topical

Indications