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A phase II clinical trial of a dental health education program delivered by aboriginal health workers to prevent early childhood caries

机译:原住民卫生工作者开展的一项牙齿健康教育计划的II期临床试验,旨在预防儿童早期龋齿

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摘要

Background: Early Childhood Caries (ECC) is a widespread problem in Australian Aboriginal communities causing severe pain and sepsis. In addition dental services are difficult to access for many Aboriginal children and trying to obtain care can be stressful for the parents. The control of dental caries has been identified as a key indictor in the reduction of Indigenous disadvantage. Thus, there is a need for new approaches to prevent ECC, which reflect the cultural norms of Aboriginal communities. Methods: This is a Phase II single arm trial designed to gather information on the effectiveness of a dental health education program for Aboriginal children aged 6 months, followed over 2 years. The program will deliver advice from Aboriginal Health Workers on tooth brushing, diet and the use of fluoride toothpaste to Aboriginal families. Six waves of data collection will be conducted to enable estimates of change in parental knowledge and their views on the acceptability of the program. The Aboriginal Health Workers will also be interviewed to record their views on the acceptability and program feasibility. Clinical data on the child participants will be recorded when they are 30 months old and compared with a reference population of similar children when the study began. Latent variable modeling will be used to interpret the intervention effects on disease outcome. Discussion: The research project will identify barriers to the implementation of a family centered Aboriginal oral health strategy, as well as the development of evidence to assist in the planning of a Phase III cluster randomized study. Trial registration: ACTRN12612000712808
机译:背景:幼儿龋齿(ECC)是澳大利亚土著社区普遍存在的问题,导致严重的疼痛和败血症。此外,许多原住民的儿童很难获得牙科服务,而试图获得照料可能会对父母造成压力。控制龋齿已被确认为减少土著人不利因素的关键指标。因此,需要一种新的预防ECC的方法,以反映土著社区的文化规范。方法:这是一项II期单臂试验,旨在收集有关6个月大,随后2年以上的土著儿童的牙齿健康教育计划的有效性的信息。该计划将向土著家庭提供有关刷牙,饮食和使用氟化物牙膏的土著健康工作者的建议。将进行六次数据收集,以评估父母知识的变化及其对计划可接受性的看法。还将采访土著卫生工作者,以记录他们对可接受性和计划可行性的看法。将在30个月大时记录儿童参与者的临床数据,并在研究开始时将其与类似儿童的参考人群进行比较。潜在变量建模将用于解释对疾病结果的干预作用。讨论:该研究项目将确定实施以家庭为中心的原住民口腔健康策略的障碍,以及发展证据以帮助计划III期整群随机研究。试用注册:ACTRN12612000712808

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