Yakima Head Start Fluoride Varnish Study

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.

Completed

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Key information

Conditions

Dental Caries Stomatognathic Diseases Tooth Demineralization Tooth Diseases

Age range

36 month–71 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Enterprise for Progress in the Community (EPIC) Head Start sites, Lower Valley, Yakima County, Washington, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fluoride varnish

Drug

Primary outcomes

Number of decayed, missing, or filled surfaces

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

Enterprise for Progress in the Community
National Institute of Dental and Craniofacial Research (NIDCR)
The Yakima Valley Farm Workers Clinic
Washington State Migrant Council

Registry information

Official study title

Fluoride Varnish Trial in High Caries Preschoolers

Important dates

Study start: 2003
Primary completion: 2005
Study completion: 2005
First posted: Aug 19, 2003
Registry last updated: May 10, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed