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Efficacy Of A PVP-I Fluoride Varnish

NCT03082196 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 284

Last updated 2020-09-10

Study results available
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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.

Conditions

  • Dental Caries

Interventions

DRUG

Test varnish

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

DRUG

Standard varnish

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

Sponsors & Collaborators

  • Advantage Dental Services, LLC

    lead INDUSTRY

Principal Investigators

  • Peter M Milgrom, DDS · Advantage Silver Dental Arrest, LLC

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
60 Months
Max Age
84 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-30
Primary Completion
2019-05-07
Completion
2019-05-07
FDA Drug
Yes

Countries

  • Micronesia

Study Locations

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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 NCT03082196 on ClinicalTrials.gov