Lecturer, Department of Prosthodontics, Faculty of Dentistry, Alexandria University, Alexandria, Egypt.
Professor, Department of Prosthodontics, Faculty of Dentistry, Alexandria University, Alexandria, Egypt.
J Prosthet Dent. 2024 Apr;131(4):633-642. doi: 10.1016/j.prosdent.2022.02.019. Epub 2022 Apr 2.
The high prevalence of obstructive sleep apnea represents a serious public health problem. Oral appliances have gained wide acceptance among patients diagnosed with obstructive sleep apnea, who should wear them every night. A comfortable oral appliance is mandatory for successful treatment outcomes.
The purpose of this randomized controlled trial was the assessment of the influence of 2 different designs of the mandibular advancement appliance (MAA), modified biblock and monoblock, for the management of obstructive sleep apnea.
The study was designed as a prospective 2-arm randomized controlled clinical trial conducted in parallel. Twenty participants (aged 40 ±7.5 years) diagnosed with moderate obstructive sleep apnea were randomly assigned to a control group (n=10), receiving monoblock MAA, and a study group (n=10), receiving modified biblock MAA with elastics. Both appliances were fabricated by using computer-aided design and computer-aided manufacture (CAD-CAM) technology at different mandibular advancement levels (MALs): 50% and 75% of maximum MAL. A total of 60 cone beam computed tomography scans, 60 overnight full polysomnography sleep tests, 60 STOP-Bang questionnaires, and 40 Usability of Sleep Apnea Equipment-Oral Appliance (USE-OA) questionnaires were collected and analyzed blindly at baseline (initial visit), 50% MAL (3 months), and 75% MAL (6 months). The main outcome measures were the upper airway volume, linear anteroposterior and cross-sectional airway measurements, Apnea Hypopnea Index, Respiratory Disturbance Index, STOP-Bang questionnaire scoring, and USE-OA questionnaire scoring. Nonparametric statistical analysis was performed by using a statistical software program (α=.05). With a beta error accepted of up to 20%, the power of the study was 80%.
At 75% MAL, the percentage change in upper airway volumetric measurements showed a favorable increase: biblock group (115%) and monoblock group (42%), with a statistically significant difference (P=.001). The linear anteroposterior airway measurements and the percentage change in cross-sectional airway measurements were statistically similar: biblock group (80%) and (75%) monoblock group (60%), (54%) (P=.450, P=.151, respectively). The percentage change in the Apnea Hypopnea Index significantly decreased: biblock group (-89%) and monoblock group (-54%) (P<.001). The percentage change in the Respiratory Disturbance Index decreased: biblock group (-78%) and monoblock group (-62%) (P<.023). From the STOP-Bang questionnaire scoring, 100% of both groups showed low risk for obstructive sleep apnea at 75% MAL. From the satisfaction scoring on the USE-OA questionnaire, the biblock group was 100% strong satisfaction and the monoblock group was 50% satisfaction and 50% fairly satisfied.
The modified biblock MAA with elastics showed significant improvements in patients diagnosed with obstructive sleep apnea regarding upper airway measurements and full polysomnography vital parameters when compared with monoblock MAA.
阻塞性睡眠呼吸暂停的高发率是一个严重的公共卫生问题。口腔器具已在被诊断为阻塞性睡眠呼吸暂停的患者中广泛接受，这些患者应每晚佩戴。舒适的口腔器具是成功治疗结果的必要条件。
本随机对照试验的目的是评估两种不同设计的下颌前伸矫治器（MAA），改良 biblock 和 monoblock，在治疗阻塞性睡眠呼吸暂停方面的影响。
该研究设计为前瞻性、双臂随机对照临床试验，平行进行。20 名（年龄 40 ± 7.5 岁）被诊断为中度阻塞性睡眠呼吸暂停的患者被随机分配到对照组（n=10），接受 monoblock MAA；研究组（n=10）接受改良 biblock MAA 加弹性装置。两种矫治器均通过计算机辅助设计和计算机辅助制造（CAD-CAM）技术在不同的下颌前伸水平（MAL）上制作：50%和 75%的最大 MAL。共采集并分析了 60 次锥形束计算机断层扫描、60 次整夜全睡眠多导睡眠图睡眠测试、60 次 STOP-Bang 问卷和 40 次睡眠呼吸暂停设备使用舒适度问卷（USE-OA），在基线（初始就诊）、50% MAL（3 个月）和 75% MAL（6 个月）时进行盲法分析。主要观察指标为上气道容积、前后向线性和横截面积气道测量、呼吸暂停低通气指数、呼吸紊乱指数、STOP-Bang 问卷评分和 USE-OA 问卷评分。使用统计软件程序（α=.05）进行非参数统计分析。接受 20%的β错误，研究的效能为 80%。
在 75% MAL 时，上气道容积测量的百分比变化显示出有利的增加：biblock 组（115%）和 monoblock 组（42%），差异有统计学意义（P=.001）。前后向气道线性测量和横截面积气道测量的百分比变化具有统计学相似性：biblock 组（80%）和 monoblock 组（75%）（60%）（54%）（P=.450，P=.151，分别）。呼吸暂停低通气指数的百分比变化显著降低：biblock 组（-89%）和 monoblock 组（-54%）（P<.001）。呼吸紊乱指数的百分比变化降低：biblock 组（-78%）和 monoblock 组（-62%）（P<.023）。从 STOP-Bang 问卷评分来看，两组在 75% MAL 时均为低阻塞性睡眠呼吸暂停风险。从 USE-OA 问卷的满意度评分来看，biblock 组为 100%强烈满意，monoblock 组为 50%满意和 50%相当满意。
与 monoblock MAA 相比，改良 biblock MAA 加弹性装置在患有阻塞性睡眠呼吸暂停的患者中对上气道测量和全睡眠多导睡眠图生命参数有显著改善。
