NCT04947527

Efficacy and Safety Evaluation of Anti-Caries Varnish

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 274 (actual)
• Sponsor: Advantage Silver Dental Arrest, LLC · Industry
• Sex: All
• Age: 10 Months – 20 Months
• Healthy volunteers: Accepted

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.

Detailed 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 6-24 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

Conditions

• Dental Caries in Children

Interventions

Type	Name	Description
DRUG	Test varnish	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.
DRUG	Placebo	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.

Timeline

• Start date: 2022-06-04
• Primary completion: 2024-06-19
• Completion: 2024-08-05
• First posted: 2021-07-01
• Last updated: 2025-10-09
• Results posted: 2025-02-03

Locations

1 site across 1 country: United States Minor Outlying Islands

Regulatory

• FDA-regulated drug study