RESUMO
OBJECTIVES: A randomized controlled trial was undertaken to investigate the orthopaedic effect of functional appliances on the pharyngeal airway space and nocturnal breathing of children with skeletal class II due to mandibular retrusion. MATERIALS AND METHODS: Forty patients were randomized into a 1:1 ratio study (Twin block) group and a control (fixed appliance) group. Each group included equal numbers of boys and girls. Diagnosis with sleep-disordered breathing was not an inclusion criterion. The duration of the trial was 12 months (T0 - T12). Eligibility criteria included skeletal Class II division 1 malocclusion with mandibular retrognathism, SNA ≥82, SNB ≤78, ANB ≥4, overjet ≥6 mm, and patients in circumpubertal stage CVM2 and CVM3. The main outcomes were pharyngeal airway volume, oxygen desaturation index (ODI), and maximum expiratory pressure (MEP), while the secondary outcomes were skeletal and dental changes of the maxilla and mandible. Randomization was accomplished with random blocks of 20 patients with allocation concealed in sequentially numbered, opaque, and sealed envelopes. Blinding was only applicable for data analysis of radiographic measurements and data extracted from the pulse oximeter. RESULTS: The mean age of the patients was 10 ± 1.5 and 10 ± 1.2 at (T0) for the Twin Block and the control groups, respectively. The changes in the oropharyngeal (2.66 cc and 0.056; P = .03) and nasopharyngeal (1.3 cc and 0.84; P = .053) airway volumes for the Twin block and control groups, respectively, were significantly different for the oropharynx. There was a significant decrease in ODI by [median -3.55 (-5.05 to 0.50); P ≤ .001] and a significant increase [median 45 (0.0-110); P ≤ .001] in MEP for the Twin block group. A significant inverse correlation (r = -.589; P = .006) could be found between the total volume of the oropharynx and ODI. No serious harm was observed. CONCLUSIONS: The Twin block group showed significant change in oropharyngeal airway volume and improvement of nocturnal breathing. REGISTRATION: This trial was registered at https://www. CLINICALTRIALS: gov, registration number NCT04255511.