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

2014-07-23 21:08:59 | BioPortfolio

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.

Description

Community-based, stratified (by location) randomized clinical trial (RCT) to determine the relative efficacy of topically applied fluoride varnish (FV) applications with and without fluoride-releasing glass ionomer (GI) sealants on occlusal surfaces of primary molars in reducing the caries incidence/increment in 3-6 year old children. A 2X2 factorial parallel groups design RCT stratified by study site (one dental and one non-dental location) will be conducted among initially 596 2.5- to 3-year-old children. Those eligible will be randomized to one of 2 groups (FV or GIS+FV) and followed for 36 months. The RCT will take place at two sites serving primarily underserved, minority and low-income populations in Southern California: 1) the dental facility of the San Ysidro Health Center (SYHC) located near the U.S.-Mexican Border serves mainly Latino immigrants, and 2) the Comprehensive Health Center - Ocean View (CHC-OV), in a non-dental setting in close proximity to its dental clinic, which serves Latino and African Americans. Both sites are part of a consortium of community clinics (SYHC Inc) and are located 15 miles apart from each other.

Annual study dental examinations will be done by the trained study dentist to determine caries (precavitated and cavitated) incidence/increment. Children identified as needing dental care will be referred for dental treatment

Study Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind (Investigator), Primary Purpose: Prevention

Conditions

Dental Caries

Intervention

Sodium Fluoride Varnish, Glass Ionomer Sealant

Location

San Ysidro Health Center
San Ysidro
California
United States
92173

Status

Not yet recruiting

Source

University of California, San Francisco

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:08:59-0400

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