Comparison between two screws for maxillary expansion: a multicenter randomized controlled trial on patient’s reported outcome measures

Abstract

Summary Objective The objective of this study was to compare an expansion screw of the maxilla that generates moderate and continuous forces versus a conventional screw for rapid maxillary expansion (RME) on patient-reported outcome measure during the first 12 weeks of treatment. Trial design This is a superiority, multicenter, two-arm parallel balanced randomization trial. Methods Patients in the mixed dentition were included with a transverse discrepancy between the two arches of at least 3 mm. An expansion screw using moderate continuous forces (Leaf group, treated with an expansion screw with Ni–Ti springs) was compared to a conventional RME screw that generates intermittent heavy forces (RME group). The primary response variable was the visual analogue scale (VAS) on pain calculated in the first 12 weeks of therapy. The VAS on difficulty on speaking and oral hygiene, patient satisfaction, and complications were also evaluated. A computer-generated block randomization was used with allocation concealed in sequentially numbered opaque-sealed envelopes. Blinding was not applicable. Linear models were used for statistical analysis. Results Twenty-eight patients in the Leaf group and 28 patients in the RME group were randomized and included in the study. There were no dropouts. The mean of the VAS for pain was 0.3 ± 0.4 in the Leaf group and 0.6 ± 0.5 in the RME group. The difference was −0.3 (95 per cent CI from −0.5 to −0.0; P = 0.017) in favour of the Leaf group. The difference in pain was marked in the first week (Leaf group 2.2 ± 2.3; RME group 3.7 ± 2.6; difference −1.5; 95 per cent CI from −2.7 to −0.3; P = 0.019). Conclusions Patients in the Leaf group experienced a lower degree of pain, especially during the first week following the application of the expander. For the other variables, no significant differences were reported between the two treatments. Registration The study was registered in the ISRCTN register on 8 November 2016 with the number ISRCTN18263886.

Comparison of rapid versus slow maxillary expansion on patient-reported outcome measures in growing patients: a systematic review and meta-analysis

“…Characteristics of included articles are presented in Table 4 . The two included studies (Ugolini et al [ 24 ]; Nieri et al [ 35 ]) were multicenter RCTs and were performed both within University Departments of Orthodontics. They were both conducted in Italy and published from 2020 to 2021.…”

“…In the study by Ugolini et al [ 24 ], the inclusion criteria were a transversal maxillary deficiency, with an intermolar width < 30 mm, with or without crossbite. In the study by Nieri et al [ 35 ], it was not specified if patients had a crossbite, and the inclusion criterion was a posterior interarch discrepancy of at least 3 mm.…”

“…In both studies the cervical stage [CS] in cervical vertebral maturation [ 45 ] was considered. In one article [ 35 ], patients were all prepubertal (CS 1 or CS 2) while in the other article [ 24 ] both prepubertal and pubertal patients (CS 1–CS 3) were comprised. Moreover, Ugolini et al [ 24 ] did not specify the dentition stage of patients while in Nieri et al study [ 35 ] patients were in either early or intermediate mixed dentition stage.…”

“…All studies involved both male and female patients. The age of patients was between 6 and 13 years in one study [ 24 ] and between 5.7 and 11.0 years of age in the other study [ 35 ].…”

“…To date, there are few studies evaluating the outcomes reported by patients with SME [ 6 , 21 , 24 , 26 , 34 , 35 ]. No systematic review evaluated PROMs after RME versus SME.…”