Preventing Caries in Preschoolers: Testing a Unique Service Delivery Model in American Indian Head Start Programs
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|ClinicalTrials.gov Identifier: NCT01116739|
Recruitment Status : Active, not recruiting
First Posted : May 5, 2010
Last Update Posted : May 10, 2018
|Condition or disease||Intervention/treatment||Phase|
|Early Childhood Dental Caries||Device: Fluoride varnish Behavioral: Oral health education Other: Dental services delivered by the Indian Health Service.||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1040 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Preventing Caries in Preschoolers: Testing a Unique Service Delivery Model in American Indian Head Start Programs|
|Study Start Date :||April 2011|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||December 2018|
Experimental: COHS administered fluoride varnish and oral health education
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 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.
Active Comparator: Usual care
Usual care will include regular dental services provided by the Indian Health Service.
Other: Dental services delivered by the Indian Health Service.
- Evaluation of decayed, missing, and filled tooth surfaces (dmfs) [ Time Frame: Over 3 years ]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.
- Acquisition of dental knowledge, attitudes, and behaviors of the caregivers of the children [ Time Frame: Over 3 years ]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.
- Evaluation of caries patterns [ Time Frame: Over 3 years ]Caries patterns will be studied in terms of the specific teeth and tooth surfaces that are affected.
- Comparison of utilization and costs of dental care [ Time Frame: Up to 3 years after randomization ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01116739
|United States, Colorado|
|University of Colorado|
|Aurora, Colorado, United States, 80045|
|Principal Investigator:||Patricia A Braun, MD MPH||University of Colorado, Denver|