Clinical Use of Aligners Associated with Nuvola((R)) OP System for Transverse Maxillary Deficiency: A Retrospective Study on 100 Patients.

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(R) 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(R) 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.