Yanamoto Souichi, Harata Saori, Miyoshi Taro, Nakamura Norio, Sakamoto Yuki, Murata Maho, Soutome Sakiko, Umeda Masahiro
Department of Clinical Oral Oncology, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan.
Department of Oral Surgery, Hironokogen Hospital, Kobe, Japan.
J Dent Sci. 2021 Jan;16(1):404-409. doi: 10.1016/j.jds.2020.08.005. Epub 2020 Aug 26.
BACKGROUND/PURPOSE: Although mandibular advancement oral appliances (OAs) are the most widely used and accepted therapeutic modality for obstructive sleep apnea (OSA), whether these maxillary and mandibular appliances should be semi-fixed or fixed remains uncertain. This randomized crossover pilot study compared the efficacy, side effects, and patient preference of semi-fixed and fixed OAs for the treatment of OSA.
Patients with mild to moderate OSA were recruited and randomly assigned to either the semi-fixed or fixed OA group, whereby they used their assigned OA for the first 4 weeks, followed by assessments for sleep parameters (including the Apnea-Hypopnea Index [AHI]) and temporomandibular joint pain as a side effect. After a two-week washout period, patients were switched to the alternative OA for 4 weeks, followed by repeated assessments. Patient preference was assessed at the end of the completed treatment period.
Fifteen patients were enrolled and completed the full study protocol. Both types of OAs were efficient in reducing the patient's AHI in comparison to baseline (i.e., without OA). However, there was no significant difference in AHI reduction between the semi-fixed and fixed OA devices. Regarding the side effect of temporomandibular joint pain and patient preference, the semi-fixed OA device was superior to the fixed OA device on both measures.
While both semi-fixed and fixed OAs are effective in treating patients with OSA, semi-fixed OAs are superior in regards to both patient preference and reduced side effects. Thus, semi-fixed OAs may be the preferred therapeutic modality for OSA.
背景/目的:尽管下颌前移口腔矫治器(OAs)是阻塞性睡眠呼吸暂停(OSA)最广泛使用和认可的治疗方式,但这些上颌和下颌矫治器应是半固定式还是固定式仍不确定。这项随机交叉试点研究比较了半固定式和固定式口腔矫治器治疗阻塞性睡眠呼吸暂停的疗效、副作用及患者偏好。
招募轻至中度阻塞性睡眠呼吸暂停患者,随机分为半固定式或固定式口腔矫治器组,患者使用分配的矫治器4周,随后评估睡眠参数(包括呼吸暂停低通气指数[AHI])以及作为副作用的颞下颌关节疼痛。经过两周的洗脱期后,患者换用另一种矫治器4周,随后再次进行评估。在完成治疗期结束时评估患者偏好。
15名患者入组并完成了完整的研究方案。与基线(即不使用矫治器)相比,两种类型的口腔矫治器均能有效降低患者的呼吸暂停低通气指数。然而,半固定式和固定式口腔矫治器在降低呼吸暂停低通气指数方面没有显著差异。在颞下颌关节疼痛副作用和患者偏好方面,半固定式口腔矫治器在这两项指标上均优于固定式口腔矫治器。
虽然半固定式和固定式口腔矫治器在治疗阻塞性睡眠呼吸暂停患者方面均有效,但半固定式口腔矫治器在患者偏好和减少副作用方面更具优势。因此,半固定式口腔矫治器可能是阻塞性睡眠呼吸暂停的首选治疗方式。