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.

Summary Objective This study aimed to compare the skeletal and dentoalveolar effects produced by slow maxillary expansion (SME) with the Leaf expander versus the conventional rapid maxillary expansion (RME) on digital dental casts, lateral and postero-anterior cephalometric radiographs. Trial design This is a superiority, two-center, two arms parallel balanced randomization trial. Methods Patients in the mixed dentition were included with a transverse interarch discrepancy of at least 3 mm. An expansion screw using moderate continuous forces (Leaf group) was compared to a conventional RME screw (RME group). The primary response variable was the difference in maxillary intermolar width (U6-U6) measured at baseline (T0) and one-year follow-up (T1) on the digital dental casts. Other dento-skeletal variables were also measured on digital dental casts and cephalograms. Computer-generated block randomization was used with allocation concealed in sequentially numbered opaque sealed envelopes. The examiner was blinded on the type of expander used. 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. U6-U6 did not show a statistically significant difference between the two groups (−0.4 mm in favor of the RME group, 95% CI from −1.2 to 0.5, P = 0.365). As for the other secondary variables no statistically significant differences were found between the two groups except maxillary intercanine width (U3-U3, −0.9 mm in favor of the RME group, 95%CI from −1.5 to −0.3, P = 0.005) and maxillary skeletal width (Mx-Mx, −1.4 mm in favor of the RME group, 95%CI from −2.4 to −0.3, P = 0.013). Conclusions No significant differences between the RME and Leaf groups were detected for any of the analyzed dento-skeletal variables except the T1-T0 differences in U3-U3 and Mx-Mx that were significantly greater in the RME group. Registration The study was registered in the ISRCTN register on 08/11/2016 with the number ISRCTN18263886. Funding No funding or conflict of interest to be declared.

The aim of this study was to assess the skeletal and dentoalveolar effects induced by the Paolone-Kaitsas functional appliance (PK appliance) in the treatment of growing patients affected by Class II malocclusion. A group of 25 Class II patients, treated with the PK appliance followed by fixed appliances, was evaluated with lateral cephalograms at the start (9.6 ± 1.6 years) and at the end of treatment (13.0 ± 1.5 years), and was compared with a matched untreated Class II control group of 23 subjects selected from the web archive of the American Association of Orthodontists Foundation Craniofacial Growth Legacy. Statistical comparisons were performed with the Student’s t-tests. The treated group showed a significant decrease in SNA (−2.2°), ANB (−2.2°), and Wits appraisal (−3.4 mm), a significant increase in the SN-palatal plane angle (1.1°), and a significant improvement in overjet (−2.9 mm), overbite (−2.5 mm), and molar relationship (3.6 mm). The PK appliance produced favorable dentoalveolar and skeletal effects: it inhibited maxillary growth without effects on the mandible and it also induced a downward inclination of the palatal plane.

The aim of the study was to evaluate the changes in skeletal, dentoalveolar, and airway dimensions induced by the mandibular anterior repositioning appliance (MARA) in the treatment of Class II malocclusion. A group of 24 Class II patients treated with MARA was evaluated with lateral cephalograms at the start (13.8 ± 2 years) and at the end of treatment (15.7 ± 1.9 years) and compared with a matched untreated Class II group of 20 subjects selected from the archive of the AOOF Legacy. Statistical comparisons were performed with the Student’s t-test. No significant differences were observed for the sagittal airway dimensions. The MARA group showed a significant improvement of Wits (−1.4 mm; p = 0.009) and ANB angle (−0.6°; p = 0.038), a reduction in the overjet (−1.9 mm; p = 0.001), of the overbite (−1.5 mm; p = 0.005), an improvement of molar relationship (1.8 mm; p = 0.000) and a proclination of the lower incisors (2.7°; p = 0.012). During active treatment, MARA did not produce significant favorable changes in the sagittal airway dimensions in Class II subjects when compared with untreated controls. Clinically, these findings highlighted that MARA was able to provide an effective correction of Class II malocclusion with favorable dentoskeletal changes.

The aim of this study was to compare the efficacy of early treatment of Class III malocclusions with rapid maxillary expansion (RME) and facial mask (FM) versus the removable mandibular retractor (RMR) re-evaluated at a postpubertal observation on lateral cephalograms. All prepubertal patients with Class III malocclusion treated consecutively from 1986 to 2013 by means of RME/FM or RMR were analyzed. Twenty-nine patients treated with RME/FM therapy and 23 patients treated with RMR were selected. Lateral cephalograms were available at 3 time points, before treatment (T1), at the end of active treatment (T2), and at a postpubertal observation (T3). Statistical comparisons were performed with independent sample t tests or Mann–Whitney tests. During the T1–T3 interval, a significantly greater maxillary protraction (SNA +1.5 mm, p = 0.031) and significantly greater improvements in ANB and Wits appraisal (+1.9 degrees, p = 0.002, and +2.2 mm, p = 0.012, respectively) were recorded in the RME/FM group. No statistically significant changes could be found in vertical skeletal measurements. In the dentoalveolar region, the RME/FM group showed a significantly greater correction of the molar relationship (−1.5 mm, p = 0.021). Early treatment of Class III malocclusion with RME/FM protocol in comparison with RMR protocol showed a greater maxillary advancement and greater improvements in sagittal skeletal Class III relationships.