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

Study Overview
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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.

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.

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

Conditions
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Fluoride Varnish and Oral Health Promotion, Usual Care

Intervention / Treatment
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* Device: Fluoride varnish
* Behavioral: Oral health education
* Other: Dental services delivered by the Indian Health Service.


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 5 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: COHS administered fluoride varnish and oral health education<br>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. | Device: Fluoride varnish<br>* Fluoride varnish will be administered by the COHS quarterly for 2 years.<br>Behavioral: Oral health education<br>* 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.<br>|
| Active Comparator: Usual care<br>Usual care will include regular dental services provided by the Indian Health Service. | Other: Dental services delivered by the Indian Health Service.<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of Decayed, Missing, and Filled Tooth Surfaces (Dmfs) at Baseline | The number of decayed, missing, and filled tooth surfaces (dmfs) for each child. The dental examiners will be trained and calibrated, and standardized criteria and instruments will be used for the detection of the dental caries. | Baseline | 
| Evaluation of Decayed, Missing, and Filled Tooth Surfaces (Dmfs) at Year 1 | The number of decayed, missing, and filled tooth surfaces (dmfs) for each child. The dental examiners will be trained and calibrated, and standardized criteria and instruments will be used for the detection of the dental caries. | 1 Year | 
| Evaluation of Decayed, Missing, and Filled Tooth Surfaces (Dmfs) at Year 2 | The number of decayed, missing, and filled tooth surfaces (dmfs) for each child. The dental examiners will be trained and calibrated, and standardized criteria and instruments will be used for the detection of the dental caries. | 2 Years | 
| Evaluation of Decayed, Missing, and Filled Tooth Surfaces (Dmfs) at Year 3 | The number of decayed, missing, and filled tooth surfaces (dmfs) for each child. The dental examiners will be trained and calibrated, and standardized criteria and instruments will be used for the detection of the dental caries. | 3 Years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acquisition of Dental Attitudes and Behaviors of the Caregivers of the Children | An automated computer assisted survey interview (ACASI)will be done of the caregivers of the children. The questions have been standardized across 6 studies from the Collaborating Research Centers to Reduce Oral Health Disparities. The survey assessing attitudes and behaviors is comprised of 12 items. Scores are calculated as a percentage of appropriate responses. Therefore, possible scores range from 0-100. | Over 3 years | 
| Evaluation of Caries Patterns | Caries patterns will be studied in terms of the specific teeth and tooth surfaces that are affected. Caries prevalence is defined as the presence of more than 0 dmfs (decayed, missing, or filled surfaces) in the child participant. The percentage of child participants with caries prevalence is reported. | Over 3 years | 
| Comparison of Utilization and Costs of Dental Care | Utilization and costs of dental care received by the children in the study will be compared, as well as the costs of the intervention program. | Up to 3 years after randomization | 
| Acquisition of Dental Knowledge of the Caregivers of the Children | An automated computer assisted survey interview (ACASI)will be done of the caregivers of the children. The questions have been standardized across 6 studies from the Collaborating Research Centers to Reduce Oral Health Disparities. The survey assessing knowledge is comprised of 14 items. Scores are calculated as a percentage of correct answers. Therefore, possible scores range from 0-100. | Over 3 years |