Clinical trial NCT01205971: Tooth Smart Healthy Start: Oral Health Advocates in Public Housing
Official title: Oral Health Advocates in Public Housing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Caries in Children
Keywords: Motivational interviewing
Community-based multimodal intervention
Dental Health Advocates
Prevention of ECC
Randomized clinical trial
Lead sponsor: Boston University
Sponsor class: OTHER
Collaborators: name: National Institute of Dental and Craniofacial Research (NIDCR)
First posted: 2010-09-21
Enrollment: 2842
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Dental caries incidence
timeFrame: 24 months
Secondary outcomes:
measure: Behavioral risk factors for early childhood caries
timeFrame: 24 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston University
state: Massachusetts
Study officials:
affiliation: Boston University
name: Michelle M Henshaw, DDS, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Brown University
name: Belinda Borrelli, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.