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



Status:Active, not recruiting
Conditions:Dental
Therapuetic Areas:Dental / Maxillofacial Surgery
Healthy:No
Age Range:3 - 5
Updated:5/12/2018
Start Date:April 2011
End Date:December 2018

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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.

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.

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.
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Aurora, Colorado 80045
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