Department of Orthodontics, Faculty of Dentistry, Mansoura University, Mansoura, Egypt.
Orthod Craniofac Res. 2024 Feb;27(1):126-138. doi: 10.1111/ocr.12696. Epub 2023 Jul 31.
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.
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.
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.
The Twin block group showed significant change in oropharyngeal airway volume and improvement of nocturnal breathing.
This trial was registered at https://www.
gov, registration number NCT04255511.
采用随机对照试验研究功能矫治器对上气道间隙和下颌后缩的骨性Ⅱ类错患者夜间呼吸的矫形效果。
40 名患者按 1:1 比例随机分为双板（Twin block）组和对照组（固定矫治器）。每组男女比例相等。诊断为睡眠呼吸障碍不是纳入标准。试验持续时间为 12 个月（T0-T12）。纳入标准包括骨性Ⅱ类 1 分类错伴下颌后缩，SNA≥82，SNB≤78，ANB≥4，覆合≥6mm，青春期 CVM2 和 CVM3 期患者。主要结果是咽腔容积、氧减指数（ODI）和最大呼气压（MEP），次要结果是上颌和下颌的骨骼和牙齿变化。采用 20 名患者的随机块进行随机分组，分配方案隐藏在顺序编号、不透明和密封的信封中。仅对 X 线片测量和脉搏血氧仪提取的数据进行数据分析进行盲法。
Twin block 组和对照组患者的平均年龄分别为 10±1.5 岁和 10±1.2 岁（T0）。双板组和对照组的口咽（2.66cc 和 0.056；P=0.03）和鼻咽（1.3cc 和 0.84；P=0.053）气道容积的变化分别显著不同。双板组 ODI 显著降低[中位数-3.55（-5.05 至 0.50）；P≤0.001]，MEP 显著升高[中位数 45（0.0-110）；P≤0.001]。口咽总容积与 ODI 之间存在显著负相关（r=-0.589；P=0.006）。未观察到严重不良事件。
双板组口咽气道容积明显增大，夜间呼吸功能改善。
该试验在 https://www.clinicaltrials.gov 上注册，注册号为 NCT04255511。
