At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase 2 Efficacy & Safety Evaluation of Advantage Anti-Caries Varnish for Primary Prevention
In Brief
A Phase 2 clinical trial evaluating Test varnish and Placebo for Dental Caries in Children. Completed, enrolled 274 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
A maximum of 0.2 mL will be applied to the teeth with a dental brush. Test or control varnish will be applied topically 4 times per year following enrollment and at each 3 to 4-month intervals.
A maximum of 0.2 mL will be applied to the teeth with a dental brush. Test or control varnish will be applied topically 4 times per year following enrollment and at each 3 to 4-month intervals.