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Efficacy and Safety Evaluation of Anti-Caries Varnish

NCT04947527 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 274

Last updated 2025-10-09

Study results available
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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.

Conditions

  • Dental Caries in Children

Interventions

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.

Sponsors & Collaborators

  • Advantage Silver Dental Arrest, LLC

    lead INDUSTRY

Principal Investigators

  • Ohnmar K Tut, BDS Phil · University of Washington

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
10 Months
Max Age
20 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-06-04
Primary Completion
2024-06-19
Completion
2024-08-05
FDA Drug
Yes

Countries

  • United States Minor Outlying Islands

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Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04947527 on ClinicalTrials.gov