van Spreuwel Peggy C J M, Jerković-Ćosić Katarina, van Loveren Cor, van der Heijden Geert J M G
Research Group Innovation in Preventive Care, Hogeschool Utrecht University of Applied Science, Utrecht, Netherlands.
Oral Public Health Department, Academic Centre for Dentistry Amsterdam, University of Amsterdam and Vrije Universiteit, Amsterdam, Netherlands.
JMIR Res Protoc. 2022 Aug 31;11(8):e39683. doi: 10.2196/39683.
Early childhood caries is considered one of the most prevalent diseases in childhood, affecting almost half of preschool-age children globally. In the Netherlands, approximately one-third of children aged 5 years already have dental caries, and dental care providers experience problems reaching out to these children.
Within the proposed trial, we aim to test the hypothesis that, compared to children who receive usual care, children who receive the Toddler Oral Health Intervention as add-on care will have a reduced cumulative caries incidence and caries incidence density at the age of 48 months.
This pragmatic, 2-arm, individually randomized controlled trial is being conducted in the Netherlands and has been approved by the Medical Ethics Research Board of University Medical Center Utrecht. Parents with children aged 6 to 12 months attending 1 of the 9 selected well-baby clinics are invited to participate. Only healthy children (ie, not requiring any form of specialized health care) with parents that have sufficient command of the Dutch language and have no plans to move outside the well-baby clinic region are eligible. Both groups receive conventional oral health education in well-baby clinics during regular well-baby clinic visits between the ages of 6 to 48 months. After concealed random allocation of interventions, the intervention group also receives the Toddler Oral Health Intervention from an oral health coach. The Toddler Oral Health Intervention combines behavioral interventions of proven effectiveness in caries prevention. Data are collected at baseline, at 24 months, and at 48 months. The primary study endpoint is cumulative caries incidence for children aged 48 months, and will be analyzed according to the intention-to-treat principle. For children aged 48 months, the balance between costs and effects of the Toddler Oral Health Intervention will be evaluated, and for children aged 24 months, the effects of the Toddler Oral Health Intervention on behavioral determinants, alongside cumulative caries incidence, will be compared.
The first parent-child dyads were enrolled in June 2017, and recruitment was finished in June 2019. We enrolled 402 parent-child dyads.
All follow-up interventions and data collection will be completed by the end of 2022, and the trial results are expected soon thereafter. Results will be shared at international conferences and via peer-reviewed publication.
Netherlands Trial Register NL8737; https://trialsearch.who.int/Trial2.aspx?TrialID=NL8737.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/39683.
幼儿龋齿被认为是儿童时期最普遍的疾病之一，全球近一半的学龄前儿童受其影响。在荷兰，约三分之一的5岁儿童已有龋齿，牙科护理人员在接触这些儿童时遇到困难。
在拟进行的试验中，我们旨在检验以下假设：与接受常规护理的儿童相比，接受幼儿口腔健康干预作为附加护理的儿童在48个月时的累积龋齿发病率和龋齿发病率密度将会降低。
这项务实的双臂、个体随机对照试验正在荷兰进行，并已获得乌得勒支大学医学中心医学伦理研究委员会的批准。邀请在9家选定的母婴保健诊所之一就诊的6至12个月大儿童的家长参与。只有父母能充分掌握荷兰语且无计划搬离母婴保健诊所所在区域的健康儿童（即不需要任何形式的专科医疗保健）符合条件。两组儿童在6至48个月的定期母婴保健诊所就诊期间，均在母婴保健诊所接受常规口腔健康教育。在对干预措施进行隐蔽随机分配后，干预组还会从口腔健康教练处接受幼儿口腔健康干预。幼儿口腔健康干预结合了已证实对预防龋齿有效的行为干预措施。在基线、24个月和48个月时收集数据。主要研究终点是48个月大儿童的累积龋齿发病率，并将根据意向性分析原则进行分析。对于48个月大的儿童，将评估幼儿口腔健康干预的成本效益平衡，对于24个月大的儿童，将比较幼儿口腔健康干预对行为决定因素以及累积龋齿发病率的影响。
第一对亲子于2017年6月入组，招募工作于2019年6月结束。我们共招募了402对亲子。
所有随访干预和数据收集将于2022年底完成，预计此后不久将得出试验结果。结果将在国际会议上分享并通过同行评审发表。
荷兰试验注册库NL8737；https://trialsearch.who.int/Trial2.aspx?TrialID=NL8737。
国际注册报告识别码（IRRID）：DERR1-10.2196/39683。
