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Glass Ionomer Sealant and Fluoride Varnish Study to Prevent Early Childhood Caries

NCT01129440 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 597

Last updated 2020-03-04

Study results available
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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.

Conditions

  • Dental Caries

Interventions

DEVICE

Fluoride Varnish

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

DEVICE

Glass Ionomer Sealant

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.

Sponsors & Collaborators

Principal Investigators

  • Francisco Ramos-Gomez, DDS, MS, MPH · University of California, Los Angeles

  • Stuart Gansky, DrPH · University of California, San Francisco

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
3 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-06-30
Primary Completion
2016-03-31
Completion
2016-03-31

Countries

  • United States

Study Locations

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Entities

Companies

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 NCT01129440 on ClinicalTrials.gov