Nasal ventilation and rapid maxillary expansion (RME): a randomized trial

Summary Objective To assess three rapid maxillary expansion (RME) appliances in nasal ventilation. Trial design Three-arm parallel randomized clinical trial. Methods Sixty-six growing subjects (10–16 years old) needing RME as part of their orthodontic treatment were randomly allocated (1:1:1 ratio) to three groups of 22 patients receiving Hyrax (H), Hybrid-Hyrax (HH), or Keles keyless expander (K). The primary outcome of nasal ventilation (pressure and velocity) and secondary outcomes (skeletal, dental, soft tissue, and nasal obstruction changes) were blindly assessed on the initial (T0) and final (T1, 6 months at appliance removal) cone-beam computed tomography (CBCT) data by applying computational fluid dynamics (CFD) method. Differences across groups were assessed with crude and adjusted for baseline values and confounders (gender, age, skeletal maturation, expansion amount, mucosal/adenoid hypertrophy, nasal septum deviation) regression models with alpha = 5%. Results Fifty-four patients were analysed (19H, 21HH, 14K). RME reduced both nasal pressure (H: −45.8%, HH: −75.5%, K: −63.2%) and velocity (H: −30%, HH: −58.5%, K: −35%) accompanied with nasal obstruction resolution (H: 26%, HH: 62%, K: 50%). Regressions accounting for baseline severity indicated HH expander performing better in terms of post-expansion maximum velocity (P = 0.03) and nasal obstruction resolution (P = 0.04), which was robust to confounders. Mucosal/adenoid hypertrophy and nasal septum deviation changes were variable, minimal, and similar across groups. The HH resulted in significantly greater increase in the nasal cross-sectional area (62.3%), anterior (14.6%), and posterior (10.5%) nasal widths. Nasal obstruction resolution was more probable among younger (P = 0.04), skeletally immature (P = 0.03), and male patients (P = 0.02) without pre-treatment mucosal hypertrophy (P = 0.04), while HH was associated with marginal greater probability for obstruction resolution. Conclusions RME resulted in improvement of nasal skeletal parameters and simulated ventilation with the former being in favour of the HH and the latter not showing significant differences among the three appliances. Limitation Attrition in the K group due to blocked activation rods possibly leading to limited sample to identify any existing group differences. Harms Replacement of blocked Keles expanders for finalizing treatment. Protocol The protocol was not published before the trial commencement. Registration Australian and New Zealand Clinical Trial Registry; ACTRN12617001136392.