Phase 2 Completed NCT03082196

Phase 2 Efficacy Evaluation Of Advantage Anti-Caries Varnish

Advantage Dental Services, LLC · Interventional, Randomized

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Dental Caries (Tooth Decay)

Study context Single-site study

Overview

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.

Full record on ClinicalTrials.gov (NCT ID NCT03082196).

Results summary

None

Outcome data

Endpoint	Type	Result	Significance
Dental Caries for Primary Molars Sound at Baseline	Primary	None	None
Dental Caries for All Primary Teeth Sound at Baseline	Primary	None	None
Child Response to First Treatment	Secondary	None	None
Child Response to Fifth Treatment	Secondary	None	None

Full results record on ClinicalTrials.gov.

Study design

Phase: Phase 2
Study type: Interventional
Allocation: Randomized
Masking: Quadruple-blind
Intervention model: Parallel assignment
Primary purpose: Prevention
Enrollment (final): 284 participants
Started: March 2017
Actually completed: May 2019

Recruitment criteria

Age range: All ages · Sex: All · Healthy volunteers: Requires diagnosis

Locationsⁱ

1 site participated during the trial period. Representative sites shown below; full historical record on ClinicalTrials.gov.

Pohnpei State Hospital — Kolonia, Pohnpei State (Micronesia)

Sources

REG

ClinicalTrials.gov — NCT03082196

Trial registry · primary record