Clinical trial NCT00067353: Yakima Head Start Fluoride Varnish Study
Official title: Fluoride Varnish Trial in High Caries Preschoolers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dental Caries
Keywords: Early Childhood Caries
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Institute of Dental and Craniofacial Research (NIDCR)
name: The Yakima Valley Farm Workers Clinic
name: Enterprise for Progress in the Community
name: Washington State Migrant Council
First posted: 2003-08-19
Enrollment: 500
Sex: ALL
Minimum age (years): 36
Maximum age (years): 71
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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:

1. 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.
2. 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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of decayed, missing, or filled surfaces
Secondary outcomes:
Other outcomes:
Locations:
city: Lower Valley, Yakima County
country: United States
facility: Enterprise for Progress in the Community (EPIC) Head Start sites
state: Washington
city: Lower Valley, Yakima County
country: United States
facility: Washington State Migrant Council Head Start sites
state: Washington
Study officials:
affiliation: Washington State Head Start Sites
name: Philip Weinstein, DDS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Weinstein P, Spiekerman C, Milgrom P. Randomized equivalence trial of intensive and semiannual applications of fluoride varnish in the primary dentition. Caries Res. 2009;43(6):484-90. doi: 10.1159/000264686. Epub 2009 Dec 10.