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

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

2060 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Study Completion Date

2018-12-31

Brief Summary

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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.

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Detailed Description

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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

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Fluoride Varnish and Oral Health Promotion Usual Care

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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COHS administered fluoride varnish and oral health education

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.

Group Type EXPERIMENTAL

Fluoride varnish

Intervention Type DEVICE

Fluoride varnish will be administered by the COHS quarterly for 2 years.

Oral health education

Intervention Type BEHAVIORAL

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.

Usual care

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

Group Type ACTIVE_COMPARATOR

Dental services delivered by the Indian Health Service.

Intervention Type OTHER

Interventions

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Fluoride varnish

Fluoride varnish will be administered by the COHS quarterly for 2 years.

Intervention Type DEVICE

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.

Intervention Type BEHAVIORAL

Dental services delivered by the Indian Health Service.

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

3 Years

Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes