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

University of California San Francisco (UCSF)

Status and phase: Completed; Phase 2

Conditions: Dental Caries

Treatments: Device: Fluoride Varnish; Device: Glass Ionomer Sealant

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01129440

U54DE019285 (U.S. NIH Grant/Contract)

NIDCR 09-014-E

Details and patient eligibility

About

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.

Full description

Community-based, stratified (by location) randomized clinical trial (RCT) to determine the relative efficacy of topically applied fluoride varnish (FV) applications alone vs FV with fluoride-releasing glass ionomer (GI) sealants on occlusal surfaces of primary molars in reducing the caries incidence and increment in 3-6 year old children. A parallel groups design RCT stratified by study site (one dental and one non-dental location) will be conducted among 596 initially 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 Latinos 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 performed by trained, calibrated, study dentists to determine caries (precavitated and cavitated) incidence and increment. Children identified as needing dental care will be referred for appropriate treatment.

Enrollment: 597 patients

Sex: All

Ages: 2 to 3 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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597 participants in 2 patient groups

Fluoride Varnish

Active Comparator group

Description:

Topical fluoride varnish (FV) applications every 6 months

Treatment:

Device: Fluoride Varnish

FV + Glass Ionomer Sealants

Experimental group

Description:

Topical fluoride varnish (FV) applications every 6 months, and fluoride-releasing glass ionomer sealants (GIS) placed on primary molars at baseline and annually, as needed

Treatment:

Device: Glass Ionomer Sealant

Device: Fluoride Varnish