Tooth Smart Healthy Start: Oral Health Advocates in Public Housing
| Tracking Information | |||||||||
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| First Received Date ICMJE | September 19, 2010 | ||||||||
| Last Updated Date | June 27, 2011 | ||||||||
| Start Date ICMJE | January 2011 | ||||||||
| Estimated Primary Completion Date | August 2015 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Dental caries incidence [ Time Frame: 24 months ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01205971 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
Behavioral risk factors for early childhood caries [ Time Frame: 24 months ] [ Designated as safety issue: No ] | ||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Tooth Smart Healthy Start: Oral Health Advocates in Public Housing | ||||||||
| Official Title ICMJE | Oral Health Advocates in Public Housing | ||||||||
| 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. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 3 | ||||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Prevention |
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| Condition ICMJE | Dental Caries | ||||||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 3720 | ||||||||
| Estimated Completion Date | August 2015 | ||||||||
| Estimated Primary Completion Date | August 2015 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | Not Provided | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01205971 | ||||||||
| Other Study ID Numbers ICMJE | 09-011-E, U54DE019275 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | Michelle Henshaw, Boston University | ||||||||
| Study Sponsor ICMJE | Boston University | ||||||||
| Collaborators ICMJE | National Institute of Dental and Craniofacial Research (NIDCR) | ||||||||
| Investigators ICMJE |
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| Information Provided By | Boston University | ||||||||
| Verification Date | June 2011 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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