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

Usual Care Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01116739
• Other study ID #: 08-0892
• Secondary ID: 1U54DE019259
• Status: Completed
• Phase: Phase 3
• Start date: April 2011
• Est. completion date: December 2018

Study information

• Verified date: May 2021
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2060
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years to 5 Years

Eligibility

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.

Related Conditions & MeSH terms

• Usual Care

Intervention

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.

Locations

Country	Name	City	State
United States	University of Colorado	Aurora	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
University of Colorado, Denver	National Institute of Dental and Craniofacial Research (NIDCR)

Country where clinical trial is conducted

United States, 

References & Publications (7)

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. Ep — View Citation

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. — View Citation

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. — View Citation

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 — View Citation

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. Erratum in: Contemp Clin Trials. 2014 May;38(1):155. — View Citation

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 collabor — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	Acquisition of Dental Attitudes and Behaviors of the Caregivers of the Children	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.	Over 3 years
Secondary	Evaluation of Caries Patterns	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.	Over 3 years
Secondary	Comparison of Utilization and Costs of Dental Care	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.	Up to 3 years after randomization
Secondary	Acquisition of Dental Knowledge of the Caregivers of the Children	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.	Over 3 years