Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2014 Mar;37(2):242-51.
doi: 10.1016/j.cct.2014.01.004. Epub 2014 Jan 25.

Preventing caries in preschoolers: successful initiation of an innovative community-based clinical trial in Navajo Nation Head Start

David O Quissell  1 , Lucinda L Bryant  2 , Patricia A Braun  3 , Diana Cudeii  4 , Nikolas Johs  5 , Vongphone L Smith  6 , Carmen George  7 , William G Henderson  8 , Judith Albino  9
Affiliations
Randomized Controlled Trial

Preventing caries in preschoolers: successful initiation of an innovative community-based clinical trial in Navajo Nation Head Start

David O Quissell et al. Contemp Clin Trials. 2014 Mar.

Erratum in

  • Contemp Clin Trials. 2014 May;38(1):155

Abstract

Navajo Nation children have the greatest prevalence of early childhood caries in the United States. This protocol describes an innovative combination of community-based participatory research and clinical trial methods to rigorously test a lay native Community Oral Health Specialists-delivered oral health intervention, with the goal of reducing the progression of disease and improving family knowledge and behaviors.

Methods/design: This cluster-randomized trial designed by researchers at the Center for Native Oral Health Research at the University of Colorado in conjunction with members of the Navajo Nation community compares outcomes between the manualized 2-year oral health fluoride varnish-oral health promotion intervention and usual care in the community (child-caregiver dyads from 26 Head Start classrooms in each study arm; total of 1016 dyads). Outcome assessment includes annual dental screening and an annual caregiver survey of knowledge, attitudes and behaviors; collection of cost data will support cost-benefit analyses.

Discussion: The study protocol meets all standards required of randomized clinical trials. Aligned with principles of community-based participatory research, extended interaction between members of the Navajo community and researchers preceded study initiation, and collaboration between project staff and a wide variety of community members informed the study design and implementation. We believe that the benefits of adding CBPR methods to those of randomized clinical studies outweigh the barriers and constraints, especially in studies of health disparities and in challenging settings. When done well, this innovative mix of methods will increase the likelihood of valid results that communities can use.

Trial registration: ClinicalTrials.gov NCT01116739.

Keywords: Clinical trial; Community-based research; Disparities; Indigenous populations; Native American; Oral health.

PubMed Disclaimer

Conflict of interest statement

Competing Interests: The authors declare that they have no conflict of interest.

Figures

Fig. 1
Fig. 1
Conceptual Framework
Fig. 2
Fig. 2
Schematic of Study Design
See this image and copyright information in PMC

References

    1. American Academy of Pediatric Dentistry. Definition of Early Childhood Caries. Pediatr Dent. 2006;28:13.
    1. Centers for Disease Control and Prevention. Children’s Oral Health: Overview. [Updated 09/10/2013]; http://www.cdc.gov/OralHealth/children_adults/child.htm.
    1. Phipps KR, Ricks TL, Manz MC, Blahut P. Prevalence and severity of dental caries among American Indian and Alaska Native preschool children. Journal of Public Health Dentistry. 2012;72:208–215. - PubMed
    1. United States Department of Health and Human Services Centers for Disease Control: Dental caries in American Indian and Alaskan native children. MMWR Morbidity/Mortality Weekly Report. 1985;34(26):400–401. - PubMed
    1. Rockville, MD: Indian Health Service, Division of Dental Services; 2002. United States Department of Health and Human Services Indian Health Service: The 1999 Oral Health Survey of American Indian and Alaska Native Dental Patients; p. 106.

Publication types

Associated data