Clinical trial NCT01116739: Preventing Caries in Preschoolers: Testing a Unique Service Delivery Model in American Indian Head Start Programs
Official title: Preventing Caries in Preschoolers: Testing a Unique Service Delivery Model in American Indian Head Start Programs
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Fluoride Varnish and Oral Health Promotion
Usual Care
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: National Institute of Dental and Craniofacial Research (NIDCR)
First posted: 2010-05-05
Enrollment: 2060
Sex: ALL
Minimum age (years): 3
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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 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
* 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.

Primary outcomes:
measure: Evaluation of Decayed, Missing, and Filled Tooth Surfaces (Dmfs) at Baseline
timeFrame: Baseline
measure: Evaluation of Decayed, Missing, and Filled Tooth Surfaces (Dmfs) at Year 1
timeFrame: 1 Year
measure: Evaluation of Decayed, Missing, and Filled Tooth Surfaces (Dmfs) at Year 2
timeFrame: 2 Years
measure: Evaluation of Decayed, Missing, and Filled Tooth Surfaces (Dmfs) at Year 3
timeFrame: 3 Years
Secondary outcomes:
measure: Acquisition of Dental Attitudes and Behaviors of the Caregivers of the Children
timeFrame: Over 3 years
measure: Evaluation of Caries Patterns
timeFrame: Over 3 years
measure: Comparison of Utilization and Costs of Dental Care
timeFrame: Up to 3 years after randomization
measure: Acquisition of Dental Knowledge of the Caregivers of the Children
timeFrame: Over 3 years
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Patricia A Braun, MD MPH
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.
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.
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.
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 collaborating centers. Prev Chronic Dis. 2014 Aug 7;11:E133. doi: 10.5888/pcd11.140140.
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. doi: 10.1007/s40615-014-0017-3.
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 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.
citation: 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.
citation: 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.