NCT01116739

Preventing Caries in Preschoolers: Testing a Unique Service Delivery Model in American Indian Head Start Programs

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 2,060 (actual)
• Sponsor: University of Colorado, Denver · Academic / Other
• Sex: All
• Age: 3 Years – 5 Years
• Healthy volunteers: Accepted

Summary

An intensive intervention of specially trained paraprofessionals, called community oral health specialists (COHS), administering on a quarterly basis for 2 years fluoride varnish and oral health promotion education, compared to usual care, will reduce decayed, missing, and filled tooth surface measures at 2 years for children in American Indian Head Start Programs.

Detailed description

The study design will be a clustered randomized design. Fifty-two head start classes in a Southwest American Indian Reservation will be randomized, 26 to the intervention program and 26 to usual care. The intervention will be comprised of specially trained paraprofessionals, called community oral health specialists (COHS), administering fluoride varnish and oral health promotion education quarterly for 2 years. Baseline and annual measures of decayed, missing, and filled tooth surfaces (dmfs) of the children, and surveys of their caregivers' dental knowledge, attitudes, and behaviors will be completed. The study will be a 5-year study, with 2 years for intake/accrual, and 3 years of follow-up.

Conditions

• Fluoride Varnish and Oral Health Promotion
• Usual Care

Interventions

Type	Name	Description
DEVICE	Fluoride varnish	Fluoride varnish will be administered by the COHS quarterly for 2 years.
BEHAVIORAL	Oral health education	Oral health education will be provided quarterly for 2 years. It will include information about how to mitigate the known risk factors for early childhood dental caries.
OTHER	Dental services delivered by the Indian Health Service.

Timeline

• Start date: 2011-04-01
• Primary completion: 2018-12-01
• Completion: 2018-12-01
• First posted: 2010-05-05
• Last updated: 2021-06-10
• Results posted: 2021-06-10

Locations

1 site across 1 country: United States