Tooth Smart Healthy Start: Oral Health Advocates in Public Housing
|ClinicalTrials.gov Identifier: NCT01205971|
Recruitment Status : Completed
First Posted : September 21, 2010
Last Update Posted : February 13, 2018
|Condition or disease||Intervention/treatment||Phase|
|Dental Caries in Children||Behavioral: Motivational Interviewing Behavioral: Dental Preventive Services||Not Applicable|
Dental caries is the most common, chronic disease of childhood, is increasing in prevalence, and disproportionately affects individuals who are financially disadvantaged and from racial and ethnic minority groups. Given the chronic nature of dental caries, clinically based preventive and restorative care alone will likely be inadequate to decrease disparities in early childhood caries (ECC) prevalence. We posit that a multimodal community-based approach, which addresses the chronic, infectious and multifactorial nature of dental caries, will be more effective than either behavioral counseling and the chemotherapeutic effects of fluoride alone. In addition to counseling and fluoride application, a successful community-based multimodal intervention will also need to equip caregivers with the skills to become involved in the prevention and management of ECC.
This group randomized clinical trial will test if a community-based multimodal intervention will reduce the 2-year ECC incidence of children aged 0-5 living in public housing developments. The intervention combines evidence based components and a unique delivery setting (public housing). We hypothesize that the multimodal intervention comprised of oral health assessment and feedback, fluoride varnish application, and motivational interviewing delivered by Dental Health Advocates (trained public housing residents) can reduce incidence of ECC in 0-5 year olds compared with a control group that receives oral health assessment and feedback, fluoride varnish application, and written oral health education materials.
This study is well poised for dissemination. Ultimately, this work could be disseminated nationwide and could potentially improve the oral health of over 500,000 family households and over 1 million children living in public housing.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2842 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Oral Health Advocates in Public Housing|
|Actual Study Start Date :||January 2011|
|Actual Primary Completion Date :||December 23, 2016|
|Actual Study Completion Date :||December 23, 2016|
Experimental: Motivational Interviewing
Motivational Interviewing to reduce caregiver risk factors for early childhood caries in their children is delivered by Dental Health Advocates (trained public housing residents) in combination with fluoride varnish applications, oral health assessments and referrals for children.
Behavioral: Motivational Interviewing
Motivational interviewing is delivered by trained public housing residents, every 3 months for a total of 8 sessions over 24 months.
Active Comparator: Dental Preventive Services
Fluoride varnish applications, written oral health educational materials regarding early childhood caries prevention, oral health assessments and referrals.
Behavioral: Dental Preventive Services
Written oral health educational materials
- Dental caries incidence [ Time Frame: 24 months ]
- Behavioral risk factors for early childhood caries [ Time Frame: 24 months ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01205971
|United States, Massachusetts|
|Boston, Massachusetts, United States, 02118|
|Principal Investigator:||Michelle M Henshaw, DDS, MPH||Boston University|
|Principal Investigator:||Belinda Borrelli, PhD||Brown University|