Dentofacial Orthopedic Treatment vs. Adenotonsillectomy in Children with Mild to Moderate OSA and Mandibular Retrognathia: A Randomized Controlled Trial

Background/Objectives: Pediatric obstructive sleep apnea (OSA), particularly when accompanied by mandibular retrognathia, presents as a complex, multifactorial condition. Dentofacial orthopedic treatment (DOT) has gained increasing clinical attention; however, high-level evidence specifically demonstrating its efficacy in pediatric OSA remains scarce. This study aimed to evaluate the efficacy of DOT and AT in managing mild to moderate OSA in children with mandibular retrognathia. Methods: This open-label, randomized controlled clinical trial recruited 93 children aged 7–10 years with mild to moderate OSA (an AHI of 1–10 events per hour) and mandibular retrognathia (ANB angle ≥ 4.5°). Participants were randomly allocated to four groups: pharmacotherapy, DOT (combined maxillary expansion and mandibular advancement appliance), AT (adenotonsillectomy under general anesthesia), and AT & DOT groups. The primary outcome was the change in apnea–hypopnea index (AHI) from baseline to 7 months post-treatment. Secondary outcomes included assessments of dentofacial development and volumetric changes in the upper airway. Results: Because of the high dropout/loss-to-follow-up rates in the pharmacotherapy and AT plus DOT groups, the final analysis was restricted to the DOT and AT groups, in which the overall dropout/loss-to-follow-up rate was 19.6%. Among the 43 participants allocated to the DOT (8 girls and 15 boys) and AT groups (8 girls and 12 boys), 36 completed the follow-up, the median baseline AHI was 3.7 events/h [IQR, 1.9–4.4]. Per protocol analysis revealed a mean reduction in AHI of 1.6 events/h in the DOT group and 1.3 events/h in the AT group, with no significant difference between the groups (−0.43 [95% CI, −1.48 to 0.61], p = 0.40). DOT significantly promoted sagittal mandibular growth without inducing a vertical clockwise rotation tendency, whereas AT had no significant effect on dentofacial development. Total upper airway volume increased significantly in both groups, with the increase concentrated in different regions of the upper airway depending on the group. Conclusions: In children with mild to moderate OSA and mandibular retrognathia, DOT demonstrated comparable efficacy to AT, which may be attributable to favorable anatomical remodeling of the upper airway.