Tooth Smart Healthy Start: Oral Health Advocates in Public Housing
Oral Health Advocates in Public Housing
2 other identifiers
interventional
2,842
1 country
1
Brief Summary
Dental caries is the most common chronic disease of childhood and is increasing in prevalence in children 2-5 years old. Racial and ethnic minority groups as well as economically disadvantaged individuals are affected the most by this health outcome. This study will test if a community-based multimodal intervention will reduce 2-year incidence of early childhood caries (ECC) in children aged 0-5 living in public housing developments. The intervention combines the components of motivational interviewing (counseling) delivered by dental health advocates, fluoride varnish application, oral health assessment and referral. The investigators hypothesize that the multimodal intervention with motivational interviewing will reduce ECC behavioral risk factors thereby leading to a reduction of ECC incidence when compared to fluoride varnish application, written oral health education materials and oral health assessment and referral.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2011
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 19, 2010
CompletedFirst Posted
Study publicly available on registry
September 21, 2010
CompletedStudy Start
First participant enrolled
January 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 23, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 23, 2016
CompletedFebruary 13, 2018
February 1, 2018
6 years
September 19, 2010
February 11, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Dental caries incidence
24 months
Secondary Outcomes (1)
Behavioral risk factors for early childhood caries
24 months
Study Arms (2)
Motivational Interviewing
EXPERIMENTALMotivational 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.
Dental Preventive Services
ACTIVE COMPARATORFluoride varnish applications, written oral health educational materials regarding early childhood caries prevention, oral health assessments and referrals.
Interventions
Motivational interviewing is delivered by trained public housing residents, every 3 months for a total of 8 sessions over 24 months.
Written oral health educational materials
Eligibility Criteria
You may qualify if:
- be living in participating public housing sites
- have one or more children 0-5 years old or be in their third trimester of pregnancy
- plan to live in their current housing development for the ensuing 24 months
- be able and willing to provide informed consent
You may not qualify if:
- caregivers unable to communicate orally in English or Spanish
- subject child has a known systemic disease associated with abnormal tooth development or abnormal oral health status such as cleft lip or palate, Burkett's lymphoma, osteogenesis imperfecta, ameliogenesis imperfecta, or dentinogenesis imperfecta
- children who have a known allergy to fluoride varnish and its components
- caregivers less than 15 years old
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Boston University
Boston, Massachusetts, 02118, United States
Related Publications (2)
Henshaw MM, Borrelli B, Gregorich SE, Heaton B, Tooley EM, Santo W, Cheng NF, Rasmussen M, Helman S, Shain S, Garcia RI. Randomized Trial of Motivational Interviewing to Prevent Early Childhood Caries in Public Housing. JDR Clin Trans Res. 2018 Oct;3(4):353-365. doi: 10.1177/2380084418794377. Epub 2018 Aug 22.
PMID: 30238060DERIVEDAlbino 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
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michelle M Henshaw, DDS, MPH
Boston University
- PRINCIPAL INVESTIGATOR
Belinda Borrelli, PhD
Brown University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
September 19, 2010
First Posted
September 21, 2010
Study Start
January 1, 2011
Primary Completion
December 23, 2016
Study Completion
December 23, 2016
Last Updated
February 13, 2018
Record last verified: 2018-02
Data Sharing
- IPD Sharing
- Will share
Researchers can make a data request through the EC4 website oralhealthdisparities.ucsf.edu