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

Phase 2

Completed

Brief 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.

Detailed 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Fluoride Varnish	Fluoride Varnish	Topical fluoride varnish (FV) applications every 6 months
FV + Glass Ionomer Sealants	Fluoride Varnish	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
FV + Glass Ionomer Sealants	Glass Ionomer Sealant	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

Primary Outcome Measures

Name	Time	Method
Caries Incidence	Assessed every 12 months (plus or minus 1 month); Month 36 reported	Caries incidence by 36 months measured by whether the change in the number of decayed, missing, or filled primary tooth surfaces (dmfs) index increased from baseline (ie. change in dmfs \>0)
Caries Increment	Assessed every 12 months (plus or minus 1 month); Month 36 reported	Caries increment by 36 months measured by the amount of change in dmfs index from baseline

Secondary Outcome Measures

Name	Time	Method
Adverse Event	every 6 months; up to 7 days after application	Clinician mediated adverse event up to 7 days after fluoride varnish application, ascertained through follow-up telephone call 5-14 days after application.
Salivary Fluoride Level	Every 6 months (plus minus 1 month); Month 30 reported	Relative changes in salivary fluoride levels pre- and post-treatment will be measured from a subsample of participating children
Caries Patterns	Assessed every 12 months (plus or minus 1 month); Month 36 reported	Determine and compare caries patterns (maxillary incisor smooth surfaces, posterior occlusal surfaces) across study arms over time. Occlusal surface dmfs\>0 in baseline eligible molar teeth.
Retention of Glass Ionomer Sealants	Assessed every at 12 months and 24 months (plus minus 1 month); Month 24 reported	Retention and maintenance of fluoride-releasing glass ionomer sealants will be recorded from a subset of children using an intraoral digital camera

Locations (1): San Ysidro Health Center
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San Ysidro, California, United States