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Tooth Smart Healthy Start: Oral Health Advocates in Public Housing

Primary Purpose

Dental Caries in Children

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Motivational Interviewing
Dental Preventive Services
Sponsored by
Boston University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Dental Caries in Children focused on measuring Motivational interviewing, Community-based multimodal intervention, Dental Health Advocates, Prevention of ECC, Randomized clinical trial

Eligibility Criteria

15 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Boston University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Motivational Interviewing

Dental Preventive Services

Arm Description

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.

Fluoride varnish applications, written oral health educational materials regarding early childhood caries prevention, oral health assessments and referrals.

Outcomes

Primary Outcome Measures

Dental caries incidence

Secondary Outcome Measures

Behavioral risk factors for early childhood caries

Full Information

First Posted
September 19, 2010
Last Updated
February 11, 2018
Sponsor
Boston University
Collaborators
National Institute of Dental and Craniofacial Research (NIDCR)
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1. Study Identification

Unique Protocol Identification Number
NCT01205971
Brief Title
Tooth Smart Healthy Start: Oral Health Advocates in Public Housing
Official Title
Oral Health Advocates in Public Housing
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
January 2011 (Actual)
Primary Completion Date
December 23, 2016 (Actual)
Study Completion Date
December 23, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Boston University
Collaborators
National Institute of Dental and Craniofacial Research (NIDCR)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Caries in Children
Keywords
Motivational interviewing, Community-based multimodal intervention, Dental Health Advocates, Prevention of ECC, Randomized clinical trial

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
2842 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Motivational Interviewing
Arm Type
Experimental
Arm Description
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.
Arm Title
Dental Preventive Services
Arm Type
Active Comparator
Arm Description
Fluoride varnish applications, written oral health educational materials regarding early childhood caries prevention, oral health assessments and referrals.
Intervention Type
Behavioral
Intervention Name(s)
Motivational Interviewing
Intervention Description
Motivational interviewing is delivered by trained public housing residents, every 3 months for a total of 8 sessions over 24 months.
Intervention Type
Behavioral
Intervention Name(s)
Dental Preventive Services
Intervention Description
Written oral health educational materials
Primary Outcome Measure Information:
Title
Dental caries incidence
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Behavioral risk factors for early childhood caries
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michelle M Henshaw, DDS, MPH
Organizational Affiliation
Boston University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Belinda Borrelli, PhD
Organizational Affiliation
Brown University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Boston University
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Researchers can make a data request through the EC4 website oralhealthdisparities.ucsf.edu
Citations:
PubMed Identifier
30238060
Citation
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.
Results Reference
derived
PubMed Identifier
28526003
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.
Results Reference
derived
Links:
URL
http://www.bu.edu/creedd
Description
Northeast Center for Research to Evaluate and Eliminate Dental Disparities

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Tooth Smart Healthy Start: Oral Health Advocates in Public Housing

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