Hemifacial microsomia (HFM), one of the most common congenital facial anomalies, was usually treated with the bilateral sagittal split osteotomy (BSSO) procedure to correct the asymmetric appearance and malocclusion of the mandible. However, the frequent post-operative relapse incidents would lead to the restoration of the mandibular segment to its preoperative position and failure of the BSSO procedure. In this study, a customized asymmetric fixed plate (CAF plate) was developed to resist relapse due to hemifacial microsomia occlusal forces and the different muscular traction forces on both sides of the mandible. For the actual HFM case in this study, the reconstructed mandibular segmental bone model was fixed using BSSO with a rectangular plate (the original CAF plate appearance) in the topology optimization analysis. With the topology optimization technique, the CAF plate was designed with a lightweight profile and excellent structural strength in consideration of the HFM asymmetrical muscle traction and occlusal force. Using biomechanical simulations, the von-Mises stress and CAF plate mandibular segment displacement and the miniplate were compared to evaluate which had superior relapse resistance. In the in-vitro biomechanical test, a fatigue force of 250,000 cycles and a constant muscle traction force were applied to the HFM mandibular model, which was fixed with the CAF plate fabricated using metal 3D printing (selective laser melting, SLM) to obtain the mandibular segment displacement as a relapse assessment. The topology optimization analysis showed that the CAF plate has the best characteristics, light weight and structural strength with 30% volume retention. The biomechanical analysis showed that the maximum von Mises stress of the mini-plate was 2.71 times higher than that of the CAF plate. The relapse displacement of the mandibular segment fixed with the mini-plate was 1.62 times higher than that fixed with the CAF plate. The CAF plate ability to resist relapse was confirmed by the biomechanical testing results so that only 0.29 mm of recurrence displacement was observed in the mandibular segment. The results indicated that the CAF plate structural strength and resistance to relapse was significantly better than that of the mini-plate. This study developed a customized asymmetric fixation plate for hemifacial microsomia, integrating topology optimization, metal 3D printing, and in vitro biomechanical testing to resist occlusal forces and differential muscle traction on both sides of the mandible to reduce relapse and improve fixation stability.
