CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 597 enrolled
Drug / intervention
Fluoride Varnish +1 moredevice
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/NCT01129440
NCT01129440Phase 2Completed
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Glass Ionomer Sealant and Fluoride Varnish Randomized Clinical Trial

University of California, San Francisco·interventional·Posted May 24, 2010·Updated Mar 4, 2020

In Brief

A Phase 2 clinical trial evaluating Fluoride Varnish and Glass Ionomer Sealant for Dental Caries. Completed, enrolled 597 participants across 1 site.

Detailed Summary

The goal of this project is to conduct a community-based randomized clinical trial to compare the caries prevention efficacy of fluoride varnish applied every six months vs. fluoride varnish applied every six months and fluoride releasing glass ionomer sealants applied annually to the eligible occlusal surfaces of primary molars in 3-6-year-old children.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDental Caries
CountriesUnited States
CollaboratorsNational Institute of Dental and Craniofacial Research (NIDCR)

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedMay 24, 2010
Enrollment StartJun 1, 2011
Primary CompletionMar 1, 2016
TodayJul 2, 2026
Enrollment to primary: 4.8 yearsPosted 16.1 years ago

Interventions

Fluoride Varnishdevice

Topical application of 0.25mL of fluoride varnish on each dental arch (upper and lower) at baseline and every 6 months.

Glass Ionomer Sealantdevice

Fluoroaluminosilicate glass powder and polyacrylic acid liquid are mixed together in a capsule to form the glass ionomer sealant material. After toothbrushing and conditioning dental surfaces with 20% polyacrylic acid for 10 seconds, pink-colored fluoride releasing glass ionomer dispensed from a capsule is applied to the occlusal (biting) surface of the molar.