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临床试验/NCT01205971
NCT01205971已完成不适用

Oral Health Advocates in Public Housing

Boston University2 个研究点 分布在 1 个国家目标入组 2,842 人开始时间: 2011年1月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
2,842
试验地点
2
主要终点
Dental caries incidence

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
15 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

Motivational Interviewing

Experimental

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.

干预措施: Motivational Interviewing (Behavioral)

Dental Preventive Services

Active Comparator

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

干预措施: Dental Preventive Services (Behavioral)

结局指标

主要结局

Dental caries incidence

时间窗: 24 months

次要结局

  • Behavioral risk factors for early childhood caries(24 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Michelle Henshaw

Professor

Boston University

研究点 (2)

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