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Abstract：
BACKGROUND: White spot lesions (WSLs) occur as a side effect in over 25 % of patients who undergo orthodontic treatment, causing aesthetic problems and a risk of deeper enamel and dentine lesions. Dutch orthodontists show substantial variation in their application of WSL preventive measures, which include little incorporation of evidence from the literature. We recently developed an evidence-based clinical practice guideline (CPG) on this topic, which was further converted into a computerized clinical decision support system (CDSS) to facilitate its incorporation into clinical practice. The present study aimed to assess the effectiveness of this CPG-based CDSS, with regard to actually preventing WSL development during orthodontic treatment with fixed appliances compared to usual preventive measures. Our study also aimed to evaluate the effects of implementing the CPG-based CDSS into routine clinical practice using a multifaceted strategy.
METHODS: We designed a hybrid effectiveness-implementation study assessing both clinical effectiveness of the CPG and its implementation into routine practice. A total of 840 patients nested in 14 orthodontic practices will be randomly assigned as clusters to the intervention or the control arm. Patients recruited by the orthodontist in the intervention group will be treated following the CPG, while the usual preventative measures will be followed in the control arm. The primary outcome measure is the proportion of patients with newly formed or enlarged WSLs after 6-9 months of treatment with fixed appliances, and at the end of treatment, using the CPG for WSL prevention compared with usual preventive measures. An additional aim is to obtain some preliminary outcomes regarding the implementation process.
CONCLUSIONS: This study investigates the effectiveness of a newly developed guideline to improve oral health during orthodontic treatment, while simultaneously illuminating potential difficulties in adopting a guideline in general orthodontic practice. The innovative features of this study include the risk-based CDSS that discriminates between patients\' oral health statuses with regard to preventive measure utilization in general orthodontic practices. Most studies focusing on WSL prevention apply the preventive intervention to each patient in an experimental setting, resulting in overtreatment and a disconnect from the real-world conditions in which the intervention is to be applied. Additionally, one of the overreaching goals of this initiative is to create a gold standard for WSL prevention during orthodontic treatment, against which future studies can compare new promising preventive measures and the readiness of clinicians to change and adopt new treatments. By doing so, we want to help bridge the gap between science and orthodontic clinical practice and improve the quality of oral health care.
BACKGROUND: This trial is registered with the Dutch Trial Registry of the Dutch Cochrane Center under number NTR5012 , registration date 2 March 2015.
METHODS: We designed a hybrid effectiveness-implementation study assessing both clinical effectiveness of the CPG and its implementation into routine practice. A total of 840 patients nested in 14 orthodontic practices will be randomly assigned as clusters to the intervention or the control arm. Patients recruited by the orthodontist in the intervention group will be treated following the CPG, while the usual preventative measures will be followed in the control arm. The primary outcome measure is the proportion of patients with newly formed or enlarged WSLs after 6-9 months of treatment with fixed appliances, and at the end of treatment, using the CPG for WSL prevention compared with usual preventive measures. An additional aim is to obtain some preliminary outcomes regarding the implementation process.
CONCLUSIONS: This study investigates the effectiveness of a newly developed guideline to improve oral health during orthodontic treatment, while simultaneously illuminating potential difficulties in adopting a guideline in general orthodontic practice. The innovative features of this study include the risk-based CDSS that discriminates between patients\' oral health statuses with regard to preventive measure utilization in general orthodontic practices. Most studies focusing on WSL prevention apply the preventive intervention to each patient in an experimental setting, resulting in overtreatment and a disconnect from the real-world conditions in which the intervention is to be applied. Additionally, one of the overreaching goals of this initiative is to create a gold standard for WSL prevention during orthodontic treatment, against which future studies can compare new promising preventive measures and the readiness of clinicians to change and adopt new treatments. By doing so, we want to help bridge the gap between science and orthodontic clinical practice and improve the quality of oral health care.
BACKGROUND: This trial is registered with the Dutch Trial Registry of the Dutch Cochrane Center under number NTR5012 , registration date 2 March 2015.
摘要：
背景：白斑病变（WSL）在接受正畸治疗的患者中有25％以上是副作用，导致美学问题和更深的釉质和牙本质病变的风险。荷兰正畸医生在应用WSL预防措施方面表现出很大差异，其中包括很少纳入文献中的证据。我们最近就这一主题制定了一项循证临床实践指南(CPG)，将其进一步转换为计算机化的临床决策支持系统（CDSS），以促进其纳入临床实践。本研究旨在评估这种基于CPG的CDSS的有效性，与常规预防措施相比，在使用固定矫治器进行正畸治疗期间实际预防WSL发展。我们的研究还旨在评估使用多方面策略将基于CPG的CDSS实施到常规临床实践中的效果。
方法：我们设计了一项混合有效性实施研究，评估CPG的临床有效性及其在常规实践中的实施。共有840名嵌套在14个正畸实践中的患者将被随机分配为干预或控制臂的集群。干预组正畸医生招募的患者将在CPG后接受治疗，而控制臂将遵循通常的预防措施。主要结果指标是使用固定矫治器治疗6-9个月后新形成或扩大的WSL患者的比例。在治疗结束时，与常规预防措施相比，使用CPG进行WSL预防。另一个目标是获得有关实施过程的一些初步结果。
结论：这项研究调查了新制定的指南在正畸治疗期间改善口腔健康的有效性，同时阐明了在一般正畸实践中采用指南的潜在困难。这项研究的创新特征包括基于风险的CDSS，该CDSS在一般正畸实践中对预防措施的利用方面区分患者的口腔健康状况。大多数专注于WSL预防的研究在实验环境中对每位患者应用预防性干预，导致过度治疗和脱离现实世界的条件，在其中的干预是适用的。此外,该计划的一个超越性目标是为正畸治疗期间的WSL预防创造一个黄金标准，未来的研究可以比较新的有希望的预防措施以及临床医生改变和采用新疗法的准备程度。通过这样做,我们希望帮助弥合科学与正畸临床实践之间的差距，提高口腔保健质量。
背景：该试验在荷兰Cochrane中心的荷兰试验登记处注册，编号为NTR5012，注册日期2015年3月2日
方法：我们设计了一项混合有效性实施研究，评估CPG的临床有效性及其在常规实践中的实施。共有840名嵌套在14个正畸实践中的患者将被随机分配为干预或控制臂的集群。干预组正畸医生招募的患者将在CPG后接受治疗，而控制臂将遵循通常的预防措施。主要结果指标是使用固定矫治器治疗6-9个月后新形成或扩大的WSL患者的比例。在治疗结束时，与常规预防措施相比，使用CPG进行WSL预防。另一个目标是获得有关实施过程的一些初步结果。
结论：这项研究调查了新制定的指南在正畸治疗期间改善口腔健康的有效性，同时阐明了在一般正畸实践中采用指南的潜在困难。这项研究的创新特征包括基于风险的CDSS，该CDSS在一般正畸实践中对预防措施的利用方面区分患者的口腔健康状况。大多数专注于WSL预防的研究在实验环境中对每位患者应用预防性干预，导致过度治疗和脱离现实世界的条件，在其中的干预是适用的。此外,该计划的一个超越性目标是为正畸治疗期间的WSL预防创造一个黄金标准，未来的研究可以比较新的有希望的预防措施以及临床医生改变和采用新疗法的准备程度。通过这样做,我们希望帮助弥合科学与正畸临床实践之间的差距，提高口腔保健质量。
背景：该试验在荷兰Cochrane中心的荷兰试验登记处注册，编号为NTR5012，注册日期2015年3月2日
