Efficacy Of A PVP-I Fluoride Varnish

Status Completed

Clinical Trial 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.

Clinical Trial Description

Objectives:

Primary

- To determine if Advantage Anti-Caries Varnish (test varnish) is superior to a control varnish containing only fluoride in the prevention of new caries lesions.

Secondary

- To establish that the response of child participants to the test varnish was not inferior to the control varnish ;

Study Design

Related Conditions & MeSH terms

Dental Caries

Clinical Trial Details

NCT number	NCT03082196
Study type	Interventional
Source	Advantage Dental Services, LLC
Contact
Status	Completed
Phase	Phase 2
Start date	March 30, 2017
Completion date	May 7, 2019

View Details

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