目的:进行了一项随机对照试验,以研究功能性矫治器对下颌骨收缩导致的II类骨骼儿童咽气道间隙和夜间呼吸的矫形效果。
方法:将40例患者随机分为1:1比例研究(Twin阻滞)组和对照组(固定矫治器)。每个组包括相等数量的男孩和女孩。睡眠呼吸紊乱的诊断不是纳入标准。试验持续时间为12个月(T0-T12)。合格标准包括骨骼II类1级错牙合伴下颌骨回颌,SNA≥82,SNB≤78,ANB≥4,超喷≥6mm,围青春期CVM2和CVM3期患者。主要结果为咽气道容积,氧饱和度指数(ODI),和最大呼气压力(MEP),而次要结果是上颌骨和下颌骨的骨骼和牙齿变化。通过随机分组完成20例患者的随机分组,并隐藏在顺序编号中,不透明,和密封的信封。致盲仅适用于射线照相测量的数据分析和从脉搏血氧计提取的数据。
结果:双阻滞组和对照组患者的平均年龄分别为10±1.5和10±1.2(T0),分别。Twin阻滞组和对照组的口咽(2.66cc和0.056;P=.03)和鼻咽(1.3cc和0.84;P=.053)气道容积的变化,分别,口咽有显著差异。双块组的ODI显着降低[中位数-3.55(-5.05至0.50);P≤.001],MEP显着增加[中位数45(0.0-110);P≤.001]。在口咽的总体积和ODI之间可以发现显著的负相关(r=-.589;P=.006)。没有观察到严重的伤害。
结论:Twin阻滞组表现出口咽气道容量的显著改变和夜间呼吸的改善。
背景:本试验在https://www注册。
结果:政府,注册号NCT04255511。
OBJECTIVE: A randomized controlled trial was undertaken to investigate the orthopaedic effect of functional appliances on the pharyngeal airway space and nocturnal breathing of children with skeletal class II due to mandibular retrusion.
METHODS: Forty patients were randomized into a 1:1 ratio study (Twin block) group and a control (fixed appliance) group. Each group included equal numbers of boys and girls. Diagnosis with sleep-disordered breathing was not an inclusion criterion. The duration of the trial was 12 months (T0 - T12). Eligibility criteria included skeletal Class II division 1 malocclusion with mandibular retrognathism, SNA ≥82, SNB ≤78, ANB ≥4, overjet ≥6 mm, and patients in circumpubertal stage CVM2 and CVM3. The main outcomes were pharyngeal airway volume, oxygen desaturation index (ODI), and maximum expiratory pressure (MEP), while the secondary outcomes were skeletal and dental changes of the maxilla and mandible. Randomization was accomplished with random blocks of 20 patients with allocation concealed in sequentially numbered, opaque, and sealed envelopes. Blinding was only applicable for data analysis of radiographic measurements and data extracted from the pulse oximeter.
RESULTS: The mean age of the patients was 10 ± 1.5 and 10 ± 1.2 at (T0) for the Twin Block and the control groups, respectively. The changes in the oropharyngeal (2.66 cc and 0.056; P = .03) and nasopharyngeal (1.3 cc and 0.84; P = .053) airway volumes for the Twin block and control groups, respectively, were significantly different for the oropharynx. There was a significant decrease in ODI by [median -3.55 (-5.05 to 0.50); P ≤ .001] and a significant increase [median 45 (0.0-110); P ≤ .001] in MEP for the Twin block group. A significant inverse correlation (r = -.589; P = .006) could be found between the total volume of the oropharynx and ODI. No serious harm was observed.
CONCLUSIONS: The Twin block group showed significant change in oropharyngeal airway volume and improvement of nocturnal breathing.
BACKGROUND: This trial was registered at https://www.
RESULTS: gov, registration number NCT04255511.