Fluoride Varnish Randomized Clinical Trial

Study Overview
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Brief Summary
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The purpose of this study is to compare the efficacy of fluoride varnish (FV) applied once or twice a year with counseling to counseling alone in preventing early childhood caries (ECC) (tooth decay in children under the age of five).

Detailed Description
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This project was a prospective, randomized clinical trial (RCT) among initially caries-free children from about six months old (when primary teeth erupt) up to age three at two public health facilities in San Francisco, one serving a primarily Latino and one a primarily Asian population. The RCT 1) Compared the efficacy of once or twice/year fluoride varnish (FV) application and counseling to counseling alone in preventing early childhood caries (ECC); 2) Assessed pre-intervention salivary markers (biologic and chemical), behavioral and demographic factors as predictors of ECC; 3) Compared the efficacy of these interventions between sites serving different ethnic populations with a high prevalence of ECC; and 4) Determined the salivary fluoride release profile following exposure to fluoride varnish.

Official Title
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Comprehensive Oral Health Center for Discovery: New Strategies for Enhancing Tissue Integrity and Repair Early Childhood Caries: Prevention and Treatment Outcomes

Conditions
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Dental Caries

Intervention / Treatment
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* Device: Fluoride Varnish


Participation Criteria
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Eligibility Criteria
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Inclusion Children < 44 months old Caries-free 4 erupted maxillary incisors Residing in fluoridated community (San Francisco) Exclusion Cleft Palate Developmental or learning disabilities Children with transient residence (homeless, migrant, foster home) Children with an another household member participating in the study

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 36 Months

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Counseling Only<br>Counseling Only | |
| Experimental: FV every 12mo for 24mo + Counsel<br>Preventive fluoride varnish every 12mo for 24mo plus Counseling | Device: Fluoride Varnish<br>* 0.1 mL (1 drop) applied on each of 2 arches<br>* Other names: Duraphat® (Colgate Oral Pharmaceuticals);|
| Experimental: FV every 6mo for 24mo + Counseling<br>Preventive fluoride varnish every 6mo for 24mo plus Counseling | Device: Fluoride Varnish<br>* 0.1 mL (1 drop) applied on each of 2 arches<br>* Other names: Duraphat® (Colgate Oral Pharmaceuticals);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Caries Incident Cases | A trained, calibrated dentist blinded to treatment arm performed visual-tactile dental exams at 1 and 2 years post-baseline. Group-specific number of incident cases were reported as the number of individual participants with caries at a follow-up visit. | two years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Early Childhood Caries