Lake Como Institute, 22100 Como, Italy.
Private Practice, 42122 Reggio Emilia, Italy.
Int J Environ Res Public Health. 2022 May 9;19(9):5751. doi: 10.3390/ijerph19095751.
Introduction: Aligners represent a common treatment for orthodontic patients thanks to their countless advantages including aesthetics, comfort, and oral hygiene maintenance; at the same time, they are associated with a reduced number of visits and a low incidence of complications. Although aligners have undergone considerable improvements over time, to date they have limitations in resolving the most serious malocclusions related to transverse maxillary deficiency. The aim of the present study was to retrospectively evaluate an orthodontic protocol (the Nuvola® OP System) which associates a morpho-functional corrector (to be used for 30 min/day) with the aligner, allowing for the treatment of cases that would be difficult or unpredictable with aligners alone. Methods: Linear measurements were taken on STL files of 100 patients. In 77 patients between 18 and 55 years (mean 28.6 ± 16.2 (standard deviation) years), 3D superimpositions of the maxilla obtained from intraoral scans before and after treatment were performed in order to evaluate the degree of maxillary expansion. The normality of the data distribution was tested. The pre- and post-treatment data were compared using a paired t-test with a 5% significance level. After treatment, a questionnaire was proposed to assess patients’ degree of satisfaction and compliance. Results: A statistically significant difference (p < 0.05) for each distance evaluated was found. The maximum expansion was obtained at the first molar level (2.35 ± 1.64 mm). Of the subjects who completed the questionnaire, 96% were satisfied and 90% were able to perform the protocol without difficulty for the required duration. Conclusions: A significant expansion of the maxillary arch as well as a high degree of patient satisfaction and compliance were observed with the Nuvola® OP System. Further studies are needed in order to clinically evaluate the relative contribution of the aligners and morpho-functional device to the obtained expansion.
由于隐形矫治器具有美观、舒适、维护口腔卫生等无数优点，同时复诊次数少、并发症发生率低，因此成为正畸患者的常用治疗方法。尽管隐形矫治器随着时间的推移已经有了很大的改进，但迄今为止，它们在解决与上颌横向发育不足相关的最严重的错颌畸形方面仍存在局限性。本研究旨在回顾性评估一种正畸方案（Nuvola® OP 系统），该方案将形态功能矫正器（每天使用 30 分钟）与隐形矫治器结合使用，以治疗仅用隐形矫治器治疗困难或不可预测的病例。
对 100 名患者的 STL 文件进行线性测量。在 77 名 18 至 55 岁（平均 28.6 ± 16.2 岁）的患者中，对治疗前后从口内扫描获得的上颌进行 3D 叠加，以评估上颌扩展程度。测试数据分布的正态性。使用具有 5%显著水平的配对 t 检验比较治疗前后的数据。治疗后，提出问卷评估患者的满意度和依从性程度。
在每个评估的距离上均发现了具有统计学意义的差异（p < 0.05）。最大扩展发生在第一磨牙水平（2.35 ± 1.64 毫米）。在完成问卷的患者中，96%的患者满意，90%的患者能够按照要求的时间轻松完成治疗方案。
Nuvola® OP 系统可显著扩大上颌弓，并获得高度的患者满意度和依从性。需要进一步的研究来临床评估隐形矫治器和形态功能矫正器对获得的扩展的相对贡献。
