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

NCT01116739 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 2060

Last updated 2021-06-10

Study results available
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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.

Conditions

  • Fluoride Varnish and Oral Health Promotion
  • Usual Care

Interventions

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.

OTHER

Dental services delivered by the Indian Health Service.

Sponsors & Collaborators

  • National Institute of Dental and Craniofacial Research (NIDCR)

    collaborator NIH

  • University of Colorado, Denver

    lead OTHER

Principal Investigators

  • Patricia A Braun, MD MPH · University of Colorado, Denver

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
5 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-04-30
Primary Completion
2018-12-31
Completion
2018-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01116739 on ClinicalTrials.gov