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

Completed · Phase 2

Conditions studied: Dental Caries

In brief

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.

Key facts

Study ID

NCT01129440

Run by

University of California, San Francisco

People needed

597

Starts

2011-06-01

Expected to finish

2016-03-01

Last updated by the study team

2020-03-04

Who can join

Age: 2 and older, up to 3. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Family resides in the South Bay or Central San Diego area
• Parent/Guardian can consent in English or Spanish
• Child has 1-8 caries-free primary molars (with no occlusal pre-cavitation and no restoration)
• Child is cooperative and behaviorally suited for the clinical trial interventions
• Child is a registered patient at San Ysidro Health Center Inc.

You may not qualify if…

• Any siblings of participants
• Child with cavitated lesions
• Child with a health condition, special need, or with a complicated factor that will prevent from completing the required number of visits during a 36-month follow-up period
• Anything, that in the opinion of the investigator, would preclude the child from complying with the protocol or jeopardize the safety of the child while on the protocol

Where it is running

• San Ysidro Health Center — San Ysidro, California, United States

Full record on ClinicalTrials.gov

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