Tooth Smart Healthy Start: Oral Health Advocates in Public Housing

Dental Caries in Children Clinical Trial

Official title:

Oral Health Advocates in Public Housing

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01205971
• Other study ID #: H-27749
• Secondary ID: U54DE019275
• Status: Completed
• Phase: N/A
• First received: September 19, 2010
• Last updated: February 11, 2018
• Start date: January 2011
• Est. completion date: December 23, 2016

Study information

• Verified date: February 2018
• Source: Boston University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2842
• Est. completion date: December 23, 2016
• Est. primary completion date: December 23, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 15 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dental Caries
• Dental Caries in Children

Intervention

Behavioral:
• Motivational Interviewing
Motivational interviewing is delivered by trained public housing residents, every 3 months for a total of 8 sessions over 24 months.
• Dental Preventive Services
Written oral health educational materials

Locations

Country	Name	City	State
United States	Boston University	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Boston University	National Institute of Dental and Craniofacial Research (NIDCR)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dental caries incidence		24 months
Secondary	Behavioral risk factors for early childhood caries		24 months

External Links

•   Northeast Center for Research to Evaluate and Eliminate Dental Disparities