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

University of Colorado Denver (CU Denver)

Status and phase: Completed; Phase 3

Conditions: Usual Care; Fluoride Varnish and Oral Health Promotion

Treatments: Device: Fluoride varnish; Other: Dental services delivered by the Indian Health Service.; Behavioral: Oral health education

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01116739

1U54DE019259 (U.S. NIH Grant/Contract)

08-0892

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,060 patients

Sex: All

Ages: 3 to 5 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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2,060 participants in 2 patient groups

COHS administered fluoride varnish and oral health education

Experimental group

Description:

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.

Treatment:

Device: Fluoride varnish

Behavioral: Oral health education

Usual care

Active Comparator group

Description:

Usual care will include regular dental services provided by the Indian Health Service.

Treatment:

Other: Dental services delivered by the Indian Health Service.