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

Phase 3

Completed

• Conditions: Usual Care; Fluoride Varnish and Oral Health Promotion
• Interventions: Other: Dental services delivered by the Indian Health Service.; Device: Fluoride varnish; Behavioral: Oral health education

• Registration Number: NCT01116739
• Lead Sponsor: University of Colorado, Denver

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2010-05-03
• Study First Submitted QC: 2010-05-03
• Study First Posted: 2010-05-05
• Study Start: 2011-04
• Primary Completion: 2018-12
• Study Completion: 2018-12
• Status Verified: 2021-05
• Results First Submitted: 2021-05-14
• Results First Submitted QC: 2021-05-14
• Last Update Submitted: 2021-05-14
• Results First Posted: 2021-06-10
• Last Update Posted: 2021-06-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2060

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

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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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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
COHS administered fluoride varnish and oral health education	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.
Usual care	Dental services delivered by the Indian Health Service.	Usual care will include regular dental services provided by the Indian Health Service.
COHS administered fluoride varnish and oral health education	Fluoride varnish	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.

Primary Outcome Measures

Name	Time	Method
Evaluation of Decayed, Missing, and Filled Tooth Surfaces (Dmfs) at Baseline	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.
Evaluation of Decayed, Missing, and Filled Tooth Surfaces (Dmfs) at Year 1	1 Year	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.
Evaluation of Decayed, Missing, and Filled Tooth Surfaces (Dmfs) at Year 2	2 Years	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.
Evaluation of Decayed, Missing, and Filled Tooth Surfaces (Dmfs) at Year 3	3 Years	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.

Secondary Outcome Measures

Name	Time	Method
Acquisition of Dental Attitudes and Behaviors of the Caregivers of the Children	Over 3 years	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.
Evaluation of Caries Patterns	Over 3 years	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.
Comparison of Utilization and Costs of Dental Care	Up to 3 years after randomization	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.
Acquisition of Dental Knowledge of the Caregivers of the Children	Over 3 years	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.

Trial Locations

Locations (1)

University of Colorado; 🇺🇸 Aurora, Colorado, United States