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

This study is currently recruiting participants.
Verified November 2012 by University of Colorado, Denver
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT01116739
First received: May 3, 2010
Last updated: November 21, 2012
Last verified: November 2012
  Purpose

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.


Condition Intervention Phase
Early Childhood Dental Caries
Device: Fluoride varnish
Behavioral: Oral health education
Other: Dental services delivered by the Indian Health Service.
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Preventing Caries in Preschoolers: Testing a Unique Service Delivery Model in American Indian Head Start Programs

Resource links provided by NLM:


Further study details as provided by University of Colorado, Denver:

Primary Outcome Measures:
  • Decayed, missing, and filled tooth surfaces (dmfs) [ Time Frame: Over 3 years ] [ Designated as safety issue: No ]
    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:
  • Dental knowledge, attitudes, and behaviors of the caregivers of the children [ Time Frame: Over 3 years ] [ Designated as safety issue: No ]
    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.

  • Caries patterns [ Time Frame: Over 3 years ] [ Designated as safety issue: No ]
    Caries patterns will be studied in terms of the specific teeth and tooth surfaces that are affected.

  • Utilization and costs of dental care [ Time Frame: Up to 3 years after randomization ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 1040
Study Start Date: April 2011
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   3 Years to 5 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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, or 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01116739

Contacts
Contact: David O Quissell, Ph.D. 303-724-4560 David.Quissell@ucdenver.edu
Contact: William Henderson, MPH, PhD 303-724-1165 William.Henderson@ucdenver.edu

Locations
United States, Colorado
University of Colorado Recruiting
Aurora, Colorado, United States, 80045
Contact: David Quissell, PhD    303-724-4560    David.Quissell@ucdenver.edu   
Contact: William G Henderson, MPH, PhD    303-724-1165    William.Henderson@ucdenver.edu   
Sponsors and Collaborators
University of Colorado, Denver
  More Information

No publications provided

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT01116739     History of Changes
Other Study ID Numbers: 08-0892, 1U54DE019259
Study First Received: May 3, 2010
Last Updated: November 21, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases
Fluorides, Topical
Fluorides
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014