患者对 Twin Block 矫治器在治疗安氏Ⅱ类错牙合中的依从性：两种复诊医嘱的随机对照试验。
Patient compliance with Twin Block appliance during treatment of Class II malocclusion: a randomized controlled trial on two check-up prescriptions.
机构信息
Department of Orthodontics, The Institute for Postgraduate Dental Education, Jönköping, Sweden.
Centre for Oral Health, School of Health and Welfare, Jönköping University, Jönköping, Sweden.
出版信息
Eur J Orthod. 2023 Mar 31;45(2):142-149. doi: 10.1093/ejo/cjac046.
BACKGROUND
Compliance is crucial for the treatment outcome with removable appliances. Previous studies on treatment with the Twin Block appliance have focused on effectiveness in relation to other treatment methods or wear-time. Studies on different check-up intervals to improve compliance seem to be lacking.
OBJECTIVES
To compare the impact of two different check-up prescriptions on patient compliance and treatment outcome during treatment with Twin Block.
TRIAL DESIGN
Two-arm parallel group, single-centre, randomized controlled trial.
MATERIALS AND METHODS
Seventy-three patients, 38 boys, and 35 girls, mean age 11.2 years, were included and block-randomized into two groups treated with a Twin Block appliance. Group 1 was called for check-up visit every sixth week and group 2 every fourth week. Compliance was evaluated with a TheraMon® microsensor, moulded into the appliance, measuring wear-time. Overjet, overbite, and molar relationships were assessed on study casts before and after treatment. The treatment outcomes were analysed on an intention-to-treat basis.
RESULTS
In group 1, the reduction of overjet was 5.2 mm and the mean wear-time was 6.9 hours. In group 2, the reduction was 4.7 mm and the wear-time was 6.1 hours. Seventy-four per cent of the patients presented an overjet of 4 mm or less. Wear-time did not correlate to age, gender, or severity of malocclusion.
HARMS
No harm was observed in any patient. Lateral open bites were registered during treatment but were normalized at the end of the treatment.
LIMITATIONS
The trial was a single-centre study and long-term effects were not evaluated.
CONCLUSIONS
During treatment with the Twin Block appliance, a 4-week check-up interval did not improve treatment outcome or increase wear-time, compared to a 6-week check-up interval. The mean wear-time was 6.5 hours per day, even if the recommendation was 12 hours.
CLINICAL TRIAL REGISTRATION
NCT05155774.
背景
对于可摘矫治器的治疗效果，顺应性至关重要。以前关于 Twin Block 矫治器治疗的研究主要集中在与其他治疗方法或佩戴时间的有效性上。关于改善顺应性的不同检查间隔的研究似乎缺乏。
目的
比较两种不同检查方案对 Twin Block 治疗期间患者顺应性和治疗效果的影响。
试验设计
双臂平行组、单中心、随机对照试验。
材料和方法
73 名患者，38 名男孩，35 名女孩，平均年龄 11.2 岁，被纳入并随机分为两组，分别使用 Twin Block 矫治器治疗。第 1 组每 6 周进行 1 次检查，第 2 组每 4 周进行 1 次检查。使用模制到矫治器中的 TheraMon®微传感器评估顺应性，以测量佩戴时间。在治疗前后的研究模型上评估了覆盖、覆颌和磨牙关系。基于意向治疗原则分析治疗结果。
结果
第 1 组的覆盖减少量为 5.2mm，平均佩戴时间为 6.9 小时。第 2 组的减少量为 4.7mm，佩戴时间为 6.1 小时。74%的患者的覆盖量为 4mm 或更少。佩戴时间与年龄、性别或错颌严重程度无关。
危害
未观察到任何患者出现危害。在治疗过程中记录到了侧方开颌，但在治疗结束时恢复正常。
局限性
该试验是一项单中心研究，未评估长期效果。
结论
与 6 周检查间隔相比，在 Twin Block 矫治器治疗期间，4 周检查间隔并未改善治疗效果或增加佩戴时间。即使推荐佩戴 12 小时，平均佩戴时间仍为每天 6.5 小时。
临床试验注册
NCT05155774。
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