Yakima Head Start Fluoride Varnish Study

Study Overview
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Brief Summary
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The aim of this study is to determine whether an annual application of three (3) fluoride varnish doses over two weeks is at least as effective in reducing cavities as the current semi-annual application.

Detailed Description
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The study population will consist of pre-school aged children who are residents of Yakima County, in central Washington State. Children will be recruited from non-migrant Head Start programs for ethnic minority farmworker children in the Yakima Valley. This study will be a randomized, double blinded trial with one experimental and one standard treatment group. Each participant will be randomly assigned to one of two study groups. The participant and the personnel conducting the study will not know to which study group the participant was assigned. This trial has two study groups: Massive Dose (Experimental): Annually for three years, children in the experimental group will receive three .30ml applications of 50mg NaF/mL fluoride varnish (CavityShieldÒ, Omni), followed 6 months later by three .30ml applications of placebo varnish in two weeks. There are 18 visits over the entire duration of the study. Each participant will receive a dental exam annually. Semiannual Dose (Standard): Annually for three years, children in the standard treatment group will receive one .30ml application of 50mg NaF/mL fluoride varnish (CavityShieldÒ, Omni) and two .30ml applications of placebo varnish in two weeks. They will receive this regimen again 6 months later. There are 18 visits over the entire duration of the study. Each participant will receive a dental exam annually. Both the experimental and standard treatment children will receive basic restorative dental care on decayed surfaces only, as well as toothbrushes for the duration of the study period. Parents will fill out questionnaires about behaviors such as diet, hygiene and prior dental care. Results will inform future treatment regimens for high-caries-risk populations.

Official Title
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Fluoride Varnish Trial in High Caries Preschoolers

Conditions
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Dental Caries

Intervention / Treatment
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* Drug: Fluoride varnish


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 36-71 months Enrolled in participating Head Start Center Plan to stay in Yakima County for duration of the study One sound tooth surface present Exclusion Criteria: No teeth present Developmentally unable to give oral assent

Ages Eligible for Study
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Minimum Age: 36 Months
Maximum Age: 71 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Fluoride varnish|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of decayed, missing, or filled surfaces |  |  | 

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