The upper airway volume effects produced by Hyrax, Hybrid-Hyrax, and Keles keyless expanders: a single-centre randomized controlled trial

Abstract

Summary Objective To assess upper airway volume changes after rapid maxillary expansion (RME) with three different expanders. Trial design Three-arm parallel randomized clinical trial. Methods Sixty-six patients, 10–16 years old, in permanent dentition, with maxillary transverse deficiency were recruited and assigned with block randomization (1:1:1 ratio) and allocation concealment to three groups of 22 patients each (Hyrax, Hybrid-Hyrax, and Keles keyless expander). The primary outcome (overall upper airway volume change) and secondary outcomes (volume changes in the nasal cavity, nasopharynx, oropharynx, and hypopharynx) were blindly assessed on the initial (T0) and final (T1, 6 months at appliance removal) cone beam computed tomography. Differences across groups were assessed with crude or adjusted for confounders (gender, age, growth stage, skeletal pattern, baseline airway volume, and amount of expansion) linear regression models. Results Fifty-one patients were analysed (19, 19, and 13 in the Hyrax, Hybrid-Hyrax, and Keles groups). Maxillary expansion resulted in considerable increases in total airway volume in the Hybrid-Hyrax group (+5902.1 mm3) and less in the Hyrax group (+2537.9 mm3) or the Keles group (+3001.4 mm3). However, treatment-induced changes for the primary and all secondary outcomes were of small magnitude and no significant difference was seen among the three expanderes in the total airway volume in either crude or adjusted analyses (P > 0.05 in all instances). Finally, among pre-peak patients (CVM 1–3), the Hybrid-Hyrax expander was associated with significantly greater increases in total airway volume compared to the Hyrax expander (P = 0.02). Conclusions RME resulted in relatively small increases in total upper airway volume and its separate compartments, with mostly no statistically significant differences across the Hyrax, Hybrid-Hyrax, and Keles groups. Limitations Significantly greater attrition was found in the Keles group due to appliance failure. The current trial might possibly be under-powered to detect differences between groups, if such exist. Harms Keles expanders blocked during activations and required substitution for completion of treatment. Protocol The protocol was not published before trial commencement. Registration Australian and New Zealand Clinical Trial Registry (ACTRN12617001136392).