Overview

This trial is active, not recruiting.

Condition early childhood dental caries
Treatments fluoride varnish, oral health education, dental services delivered by the indian health service.
Phase phase 3
Sponsor University of Colorado, Denver
Collaborator National Institute of Dental and Craniofacial Research (NIDCR)
Start date April 2011
End date December 2016
Trial size 1040 participants
Trial identifier NCT01116739, 08-0892, 1U54DE019259

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose prevention
Arm
(Experimental)
Paraprofessionals, called community oral health specialists (COHS), will be trained to administer fluoride varnish and oral health education to head start children quarterly for 2 years.
fluoride varnish
Fluoride varnish will be administered by the COHS quarterly for 2 years.
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.
(Active Comparator)
Usual care will include regular dental services provided by the Indian Health Service.
dental services delivered by the indian health service.

Primary Outcomes

Measure
Evaluation of decayed, missing, and filled tooth surfaces (dmfs)
time frame: Over 3 years

Secondary Outcomes

Measure
Acquisition of dental knowledge, attitudes, and behaviors of the caregivers of the children
time frame: Over 3 years
Evaluation of caries patterns
time frame: Over 3 years
Comparison of utilization and costs of dental care
time frame: Up to 3 years after randomization

Eligibility Criteria

Male or female participants from 3 years up to 5 years old.

Inclusion Criteria: - Children ages 3-5 enrolled in Head Start Centers on a Southwest Indian Reservation and having a primary caregiver (preferably mother, or the child's legal guardian as documented by the HSC) - American Indian, as defined by the tribe, or - Children of other racial/ethnic groups who are in the Head Start classes on the Reservation - Parent/caregiver able to read, understand, and sign the study consent form, and - Willing and able to follow the study procedures and instructions Exclusion Criteria: - Allergy to any of the components of the fluoride varnish - Ulcerative gingivitis - Stomatitis - Other conditions resulting in disrupted or irritated oral mucosa - Any other conditions or findings that, in the opinion of the investigators, would interfere with or preclude participation in the study.

Additional Information

Official title Preventing Caries in Preschoolers: Testing a Unique Service Delivery Model in American Indian Head Start Programs
Principal investigator Patricia A Braun, MD MPH
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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by University of Colorado, Denver.