NCT01116739

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,060

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Apr 2011

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 3, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 5, 2010

Completed
11 months until next milestone

Study Start

First participant enrolled

April 1, 2011

Completed
7.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
2.5 years until next milestone

Results Posted

Study results publicly available

June 10, 2021

Completed
Last Updated

June 10, 2021

Status Verified

May 1, 2021

Enrollment Period

7.7 years

First QC Date

May 3, 2010

Results QC Date

May 14, 2021

Last Update Submit

May 14, 2021

Conditions

Fluoride Varnish and Oral Health PromotionUsual Care

Outcome Measures

Primary Outcomes (4)

  • Evaluation of Decayed, Missing, and Filled Tooth Surfaces (Dmfs) at 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

    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

    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

    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 Outcomes (4)

  • Acquisition of Dental Attitudes and Behaviors of the Caregivers of the Children

    Over 3 years

  • Evaluation of Caries Patterns

    Over 3 years

  • Comparison of Utilization and Costs of Dental Care

    Up to 3 years after randomization

  • Acquisition of Dental Knowledge of the Caregivers of the Children

    Over 3 years

Study Arms (2)

COHS administered fluoride varnish and oral health education

EXPERIMENTAL

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 varnishBehavioral: Oral health education

Usual care

ACTIVE COMPARATOR

Usual care will include regular dental services provided by the Indian Health Service.

Other: Dental services delivered by the Indian Health Service.

Interventions

Fluoride varnishDEVICE

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

COHS administered fluoride varnish and oral health education
Oral health educationBEHAVIORAL

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.

COHS administered fluoride varnish and oral health education
Dental services delivered by the Indian Health Service.OTHER
Usual care

Eligibility Criteria

Age3 Years - 5 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Colorado

Aurora, Colorado, 80045, United States

Location

Related Publications (9)

  • Quissell DO, Bryant LL, Braun PA, Cudeii D, Johs N, Smith VL, George C, Henderson WG, Albino J. Preventing caries in preschoolers: successful initiation of an innovative community-based clinical trial in Navajo Nation Head Start. Contemp Clin Trials. 2014 Mar;37(2):242-51. doi: 10.1016/j.cct.2014.01.004. Epub 2014 Jan 25.

    PMID: 24469238BACKGROUND

  • Albino J, Tiwari T, Henderson WG, Thomas J, Bryant LL, Batliner TS, Braun PA, Wilson A, Quissell DO. Learning from caries-free children in a high-caries American Indian population. J Public Health Dent. 2014 Fall;74(4):293-300. doi: 10.1111/jphd.12058. Epub 2014 Jun 24.

    PMID: 24961881RESULT

  • Batliner T, Wilson AR, Tiwari T, Glueck D, Henderson W, Thomas J, Braun P, Cudeii D, Quissell D, Albino J. Oral health status in Navajo Nation Head Start children. J Public Health Dent. 2014 Fall;74(4):317-25. doi: 10.1111/jphd.12061. Epub 2014 Jun 23.

    PMID: 24954053RESULT

  • Braun PA, Lind KE, Henderson WG, Brega AG, Quissell DO, Albino J. Validation of a pediatric oral health-related quality of life scale in Navajo children. Qual Life Res. 2015 Jan;24(1):231-9. doi: 10.1007/s11136-014-0751-3. Epub 2014 Jul 9.

    PMID: 25005885RESULT

  • Tiwari T, Casciello A, Gansky SA, Henshaw M, Ramos-Gomez F, Rasmussen M, Garcia RI, Albino J, Batliner TS; Early Childhood Caries Collaborating Centers. Recruitment for health disparities preventive intervention trials: the early childhood caries collaborating centers. Prev Chronic Dis. 2014 Aug 7;11:E133. doi: 10.5888/pcd11.140140.

    PMID: 25101490RESULT

  • Tiwari T, Quissell DO, Henderson WG, Thomas JF, Bryant LL, Braun PA, Albino JE. Factors Associated with Oral Health Status in American Indian Children. J Racial Ethn Health Disparities. 2014 Sep 1;1(3):148-156. doi: 10.1007/s40615-014-0017-3.

    PMID: 25232515RESULT

  • Braun PA, Quissell DO, Henderson WG, Bryant LL, Gregorich SE, George C, Toledo N, Cudeii D, Smith V, Johs N, Cheng J, Rasmussen M, Cheng NF, Santo W, Batliner T, Wilson A, Brega A, Roan R, Lind K, Tiwari T, Shain S, Schaffer G, Harper M, Manson SM, Albino J. A Cluster-Randomized, Community-Based, Tribally Delivered Oral Health Promotion Trial in Navajo Head Start Children. J Dent Res. 2016 Oct;95(11):1237-44. doi: 10.1177/0022034516658612. Epub 2016 Jul 20.

    PMID: 27439724RESULT

  • Wilson AR, Tiwari T, Thomas JF, Henderson WG, Braun PA, Albino J. Validation of Psychosocial Measures Assessing American Indian Parental Beliefs Related to Control over Their Children's Oral Health. Int J Environ Res Public Health. 2020 Jan 8;17(2):403. doi: 10.3390/ijerph17020403.

    PMID: 31936256DERIVED

  • Albino J, Tiwari T, Gansky SA, Henshaw MM, Barker JC, Brega AG, Gregorich SE, Heaton B, Batliner TS, Borrelli B, Geltman P, Kressin NR, Weintraub JA, Finlayson TL, Garcia RI; Early Childhood Caries Collaborating Centers. The basic research factors questionnaire for studying early childhood caries. BMC Oral Health. 2017 May 19;17(1):83. doi: 10.1186/s12903-017-0374-5.

    PMID: 28526003DERIVED

MeSH Terms

Interventions

Health Education, Dental

Intervention Hierarchy (Ancestors)

Health EducationPreventive Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesPublic Health DentistryEnvironment and Public Health

Results Point of Contact

Title
Patricia A. Braun
Organization
University of Colorado Denver
clinicalresearchsupportcenter@ucdenver.edu
3037241111

Study Officials

  • Patricia A Braun, MD MPH

    University of Colorado, Denver

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 3, 2010

First Posted

May 5, 2010

Study Start

April 1, 2011

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

June 10, 2021

Results First Posted

June 10, 2021

Record last verified: 2021-05

Locations

US(1)