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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Glass Ionomer Sealant and Fluoride Varnish Randomized Clinical Trial

Conditions
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Dental Caries

Intervention / Treatment
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* Device: Fluoride Varnish
* Device: Glass Ionomer Sealant


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 3 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Fluoride Varnish<br>Topical fluoride varnish (FV) applications every 6 months | Device: Fluoride Varnish<br>* Topical application of 0.25mL of fluoride varnish on each dental arch (upper and lower) at baseline and every 6 months.<br>* Other names: 3M ESPE CavityShield® single-dose fluoride varnish units;|
| Experimental: FV + Glass Ionomer Sealants<br>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 | Device: Fluoride Varnish<br>* Topical application of 0.25mL of fluoride varnish on each dental arch (upper and lower) at baseline and every 6 months.<br>* Other names: 3M ESPE CavityShield® single-dose fluoride varnish units;Device: Glass Ionomer Sealant<br>* 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.<br>* Other names: GC Fuji TRIAGE CAPSULE and its conditioner;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Caries Incidence | 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) | Assessed every 12 months (plus or minus 1 month); Month 36 reported | 
| Caries Increment | Caries increment by 36 months measured by the amount of change in dmfs index from baseline | Assessed every 12 months (plus or minus 1 month); Month 36 reported | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Caries Patterns | 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. | Assessed every 12 months (plus or minus 1 month); Month 36 reported | 
| Salivary Fluoride Level | Relative changes in salivary fluoride levels pre- and post-treatment will be measured from a subsample of participating children | Every 6 months (plus minus 1 month); Month 30 reported | 
| Retention of Glass Ionomer Sealants | Retention and maintenance of fluoride-releasing glass ionomer sealants will be recorded from a subset of children using an intraoral digital camera | Assessed every at 12 months and 24 months (plus minus 1 month); Month 24 reported | 
| Adverse Event | Clinician mediated adverse event up to 7 days after fluoride varnish application, ascertained through follow-up telephone call 5-14 days after application. | every 6 months; up to 7 days after application | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Children, Fluoride varnish, Glass ionomer sealant, Prevention