Skip to main content
OpenTrials
Completed

NCT Number: NCT01116739

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Fluoride Varnish and Oral Health Promotion Usual Care

Age range

3 year–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University of Colorado

Aurora, Colorado, 80045, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Fluoride varnish

Device

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

Oral Health Education

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.

Dental services delivered by the Indian Health Service.

Other

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • National Institute of Dental and Craniofacial Research (NIDCR)

Registry information

Important dates

Study start
2011
Primary completion
2018
Study completion
2018
First posted
May 5, 2010
Registry last updated
Jun 10, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.