Abstract
OBJECTIVES: To evaluate the clinical efficacy of an autonomous robotic system in reducing bone resection volume and operative time for impacted teeth extraction in children, compared to conventional surgical techniques. METHODS: A single-blinded randomized controlled trial enrolled 10 pediatric patients impacted teeth. Each participant received robotic surgery (test group) and conventional surgery (control group) on contralateral quadrants. Primary outcomes were bone resection volume ratio (measured via pre-/post-op CBCT segmentation) and operative time. Secondary outcomes included nerve injury incidence and healing outcomes. Differences were analyzed via paired t-tests and generalized estimating equations. RESULTS: In this RCT of 10 children with impacted teeth, robotic surgery reduced total operative time by 35% (30.7 ± 6.3 vs. 39.3 ± 4.2 min, p < 0.05) and bone resection time by 65% (8.6 ± 3.3 vs. 24.2 ± 4.8 min, p < 0.001), while eliminating nerve injuries (0 vs. 1 case). Volumetric analysis confirmed 42% less bone resection (56.8 ± 9.2% vs. 98.4 ± 13.2%, p < 0.001) through automated segmentation and Boolean subtraction. CONCLUSION: This first RCT on autonomous robotic surgery for pediatric impacted teeth confirms its minimal invasiveness, and operative efficiency. The system significantly reduces bone loss while ensuring anatomical safety in complex pediatric cases. CLINICAL SIGNIFICANCE: As the pioneering autonomous robotic platform validated through RCT for pediatric oral surgery, this technology offers a clinically viable solution to minimize surgical trauma and operative risks in children, addressing critical challenges in dentoalveolar procedures. REGISTRY: Chinese Clinical Trial Registry, TRN: ChiCTR2400092822, Registration date: 25 November 2024.