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

May 14, 2021 updated by: University of Colorado, Denver
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

2060

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 5 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Device: Fluoride varnish
Fluoride varnish will be administered by the COHS quarterly for 2 years.
Behavioral: 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.
Active Comparator: Usual care
Usual care will include regular dental services provided by the Indian Health Service.
Other: Dental services delivered by the Indian Health Service.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of Decayed, Missing, and Filled Tooth Surfaces (Dmfs) at Baseline
Time Frame: 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
Time Frame: 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.
1 Year
Evaluation of Decayed, Missing, and Filled Tooth Surfaces (Dmfs) at Year 2
Time Frame: 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.
2 Years
Evaluation of Decayed, Missing, and Filled Tooth Surfaces (Dmfs) at Year 3
Time Frame: 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.
3 Years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acquisition of Dental Attitudes and Behaviors of the Caregivers of the Children
Time Frame: 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.
Over 3 years
Evaluation of Caries Patterns
Time Frame: 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.
Over 3 years
Comparison of Utilization and Costs of Dental Care
Time Frame: 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.
Up to 3 years after randomization
Acquisition of Dental Knowledge of the Caregivers of the Children
Time Frame: 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.
Over 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Colorado, Denver

Collaborators

National Institute of Dental and Craniofacial Research (NIDCR)

Investigators

  • Principal Investigator: Patricia A Braun, MD MPH, University of Colorado, Denver

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2011

Primary Completion (Actual)

December 1, 2018

Study Completion (Actual)

December 1, 2018

Study Registration Dates

First Submitted

May 3, 2010

First Submitted That Met QC Criteria

May 3, 2010

First Posted (Estimate)

May 5, 2010

Study Record Updates

Last Update Posted (Actual)

June 10, 2021

Last Update Submitted That Met QC Criteria

May 14, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 08-0892
  • 1U54DE019259 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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