Preventing Caries in Preschoolers: Testing a Unique Service Delivery Model in American Indian Head Start Programs
Completed · Phase 3
Conditions studied: Fluoride Varnish and Oral Health Promotion, Usual Care
In brief
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.
Key facts
- Study ID
- NCT01116739
- Run by
- University of Colorado, Denver
- People needed
- 2060
- Starts
- 2011-04-01
- Expected to finish
- 2018-12-01
- Last updated by the study team
- 2021-06-10
Who can join
Age: 3 and older, up to 5. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- University of Colorado — Aurora, Colorado, United States
Full record on ClinicalTrials.gov
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