Assessment of accuracy and efficiency of guided fixation of customized 3D miniplates vs Champy's technique in stabilization of mandibular angle fractures: A randomized controlled trial

The objectives of this study were; (1) to assess the accuracy of virtual surgical planning (VSP) and computer aided design and manufacturing (CAD/CAM) in creating an anatomically oriented, bone-borne fracture reduction/plate positioning patient specific surgical guide (PSSG) and a customized three-dimensional (3D) miniplate to achieve anatomical reduction and stabilization of fractured segments in mandibular angle fractures (MAF) via a more esthetic, less complication-laden intraoral access, and (2) to evaluate efficiency of customized 3D miniplates in reestablishment of masticatory function.

Twenty-four patients were included and randomly allocated into 2 groups; group I, where open reduction and internal fixation (ORIF) of MAF was performed using a fracture reduction/plate positioning PSSG and a customized 3D miniplate and group II, where ORIF of MAF was performed using a single 2.0 superior border miniplate (Champy's technique). Assessment of accuracy of VSP in group I was carried out by superimposition of 3D virtual models of virtually preoperatively reduced mandible over those of surgically reduced and stabilized mandibles at 1 week and 6 months postoperatively. Clinical assessments of maximum bite force in Newtons (N) using a bite force measurement device as well as occlusion status according to the following scale: satisfactory (no gap), mild derangement (gap of 1-2 mm) or marked derangement (gap more than 2 mm) were carried out at 1 week, 1, 3 and 6 months postoperatively.