Tooth Smart Healthy Start: Oral Health Advocates in Public Housing

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
Dental Caries in Children	Behavioral: Motivational Interviewing; Behavioral: Dental Preventive Services	Not Applicable

Detailed Description:

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 Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	2842 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Single (Outcomes Assessor)
Primary Purpose:	Prevention
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

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
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

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Dental caries incidence [ Time Frame: 24 months ]

Secondary Outcome Measures :

1. Behavioral risk factors for early childhood caries [ Time Frame: 24 months ]

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	15 Years and older (Child, Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Contacts and Locations

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Locations

United States, Massachusetts
Boston University
Boston, Massachusetts, United States, 02118

Sponsors and Collaborators

Boston University

National Institute of Dental and Craniofacial Research (NIDCR)

Investigators

Principal Investigator:	Michelle M Henshaw, DDS, MPH	Boston University
Principal Investigator:	Belinda Borrelli, PhD	Brown University

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

Northeast Center for Research to Evaluate and Eliminate Dental Disparities 

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

Responsible Party:	Michelle Henshaw, Professor, Boston University
ClinicalTrials.gov Identifier:	NCT01205971 History of Changes
Other Study ID Numbers:	H-27749; U54DE019275 ( U.S. NIH Grant/Contract )
First Posted:	September 21, 2010
Last Update Posted:	February 13, 2018
Last Verified:	February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	Yes
Plan Description:	Researchers can make a data request through the EC4 website oralhealthdisparities.ucsf.edu

Studies a U.S. FDA-regulated Drug Product:		No
Studies a U.S. FDA-regulated Device Product:		No

Keywords provided by Michelle Henshaw, Boston University:

Motivational interviewing; Community-based multimodal intervention; Dental Health Advocates; Prevention of ECC; Randomized clinical trial

Additional relevant MeSH terms:

Dental Caries; Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases