Shanghai Stomatological Hospital, Department of Pediatric Dentistry, Fudan University Affliated Stomatological Hospital, Shanghai, China.
Shanghai Key Laboratory of Craniomaxillofacial Development and Diseases, Fudan University, Shanghai, China.
BMJ Open. 2022 Apr 26;12(4):e055964. doi: 10.1136/bmjopen-2021-055964.
Orthodontic treatment and adenotonsillectomy (AT) are both conventional treatments for paediatric obstructive sleep apnoea (OSA). Each approach has distinct treatment advantages; however, there is currently a lack of solid evidence to support their efficacy comparison. We hypothesise that the objective effect of orthodontic treatment is not inferior to AT in children with moderate OSA and mandibular retrognathia, but orthodontic treatment has the advantage of promoting dentofacial growth.
This is a randomised, open-label, parallel-group, active controlled trial that will study the efficacy of orthodontic treatment versus AT in children with moderate OSA accompanied by tonsillar adenoid hypertrophy and mandibular retrognathia. A total of 98 patients will be enrolled and randomised in a 2:1 ratio to either orthodontic treatment or AT group. Participants will be recruited at Shanghai Stomatological Hospital, Shanghai Children's Hospital of Shanghai Jiaotong University and Children's Hospital of Fudan University, which are all located in Shanghai, China. The primary endpoint is the per cent change in the obstructive apnoea-hypopnoea index from baseline (month 0) to the primary endpoint (month 7), and the mean reduction in A point, nasion and B point angle on cephalometric measurements by lateral X-ray films. Important secondary efficacy endpoints include sleep duration with oxygen saturation below 90% according to polysomnography and subjective symptoms (assessed by the OSA-20 questionnaire), etc. Safety endpoints will also be evaluated.
The study was approved by the ethics committees of Shanghai Stomatological Hospital (approval no. (2021)002), Shanghai Children's Hospital of Shanghai Jiaotong University (approval no. 2021R046-F01) and Children's Hospital of Fudan University (approval no. (2021)136). Before enrolment, a qualified clinical research assistant will obtain written informed consent from both the participants and their guardians after full explanation of this study. The results will be presented at national or international conferences and published in peer-reviewed journals.
ChiCTR2000037288.
正畸治疗和腺样体扁桃体切除术（adenotonsillectomy，AT）都是儿科阻塞性睡眠呼吸暂停（obstructive sleep apnea，OSA）的常规治疗方法。每种方法都有其独特的治疗优势；然而，目前缺乏确凿的证据支持它们的疗效比较。我们假设，在伴有扁桃体腺样体肥大和下颌后缩的中度 OSA 儿童中，正畸治疗的客观效果并不逊于 AT，但正畸治疗具有促进牙颌面生长的优势。
这是一项随机、开放标签、平行组、阳性对照试验，旨在研究正畸治疗与 AT 在伴有扁桃体腺样体肥大和下颌后缩的中度 OSA 儿童中的疗效。将招募 98 名患者，并按照 2:1 的比例随机分为正畸治疗组或 AT 组。参与者将在上海口腔医院、上海交通大学附属上海儿童医学中心和复旦大学附属儿科医院招募，这些医院均位于中国上海。主要终点是从基线（第 0 个月）到主要终点（第 7 个月）时阻塞性呼吸暂停低通气指数的百分比变化，以及侧位 X 线片上 A 点、前颅底点和 B 点角度的平均减少。重要的次要疗效终点包括多导睡眠图监测下的血氧饱和度低于 90%的睡眠时间和主观症状（用 OSA-20 问卷评估）等。还将评估安全性终点。
该研究得到了上海口腔医院伦理委员会（批准号（2021）002）、上海交通大学附属上海儿童医学中心伦理委员会（批准号 2021R046-F01）和复旦大学附属儿科医院伦理委员会（批准号（2021）136）的批准。入组前，合格的临床研究助理将在充分解释本研究后，从参与者及其监护人处获得书面知情同意。研究结果将在国内外会议上报告，并发表在同行评议期刊上。
ChiCTR2000037288。
