CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 284 enrolled
Drug / intervention
Test varnish +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03082196
NCT03082196Phase 2Completed
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Phase 2 Efficacy Evaluation Of Advantage Anti-Caries Varnish

Advantage Dental Services, LLC·interventional·Posted Mar 17, 2017·Updated Sep 10, 2020

In Brief

A Phase 2 clinical trial evaluating Test varnish and Standard varnish for Dental Caries. Completed, enrolled 284 participants across 1 site.

Detailed Summary

The purpose of the study is to determine the efficacy of Advantage Anti-Caries Varnish. Single-center, double-blind, controlled Phase 2 study with parallel groups of children. Subjects will be stratified by early childhood education center and then randomized to receive either test varnish or control varnish topically to the teeth. Treatment will be administered quarterly for up to 24 months. The primary outcome is surface-level primary molar caries increment (d2-4mfs) at 24- months post baseline.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDental Caries
CountriesMicronesia
Collaborators--

Timeline

Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedMar 17, 2017
Enrollment StartMar 30, 2017
Primary CompletionMay 7, 2019
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 9.3 years ago

Interventions

Test varnishdrug

Topical application of test varnish to the teeth 4 times per year.

Standard varnishdrug

Topical application of test varnish to the teeth 4 times per year