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Tooth Smart Healthy Start: Oral Health Advocates in Public Housing

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Michelle Henshaw, Boston University
ClinicalTrials.gov Identifier:
NCT01205971
First received: September 19, 2010
Last updated: April 7, 2014
Last verified: April 2014
  Purpose

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 Intervention Phase
Dental Caries
Behavioral: Motivational Interviewing
Behavioral: Preventive Dental Services
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Oral Health Advocates in Public Housing

Resource links provided by NLM:


Further study details as provided by Boston University:

Primary Outcome Measures:
  • Dental caries incidence [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Behavioral risk factors for early childhood caries [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 3720
Study Start Date: January 2011
Estimated Study Completion Date: August 2016
Estimated Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 education materials regarding early childhood caries prevention, oral health assessments and referrals.
Behavioral: Preventive Dental Services
Written oral health educational materials

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.

  Eligibility

Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01205971

Locations
United States, Massachusetts
Boston University
Boston, Massachusetts, United States, 02118
Sponsors and Collaborators
Boston University
Investigators
Principal Investigator: Michelle M Henshaw, DDS, MPH Boston University
Principal Investigator: Belinda Borrelli, PhD Brown University
  More Information

Additional Information:
No publications provided

Responsible Party: Michelle Henshaw, Professor, Boston University
ClinicalTrials.gov Identifier: NCT01205971     History of Changes
Other Study ID Numbers: 09-011-E, U54DE019275
Study First Received: September 19, 2010
Last Updated: April 7, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Dental Caries
Stomatognathic Diseases
Tooth Demineralization
Tooth Diseases

ClinicalTrials.gov processed this record on November 27, 2014