Comparison of Patient-Specific Condylar Positioning Devices and Manual Methods in Orthognathic Surgery: A Prospective Randomized Trial

Abstract

Background: This study investigated whether patient-specific condylar positioning devices (CPDs) are beneficial compared to the conventional manual positioning of the condyles. Methods: In this prospective, randomized trial, patients undergoing orthognathic surgery with a bilateral sagittal split osteotomy of the mandible were included. The ascending ramus was positioned with computer-aided designed and computer-aided manufactured (CAD/CAM) patient-specific devices in the CPD group and manually in the control group. Postoperatively, cone-beam computed tomography (CBCT) was performed to align the virtually planned position with the postoperative result. Results: Thirty patients were enrolled in the study, with 14 randomized to the CPD group and 16 to the control group. In the CPD group, the ascending ramus differed in the postoperative CBCT scan from the virtually planned position by 0.8 mm in the left/right, 0.8 mm in the front/back, and 1.3 mm in the cranial/caudal direction. The corresponding control-group values were 1.1 mm, 1.3 mm, and 1.6 mm. CPD and controls differed significantly for the left/right movement of the rami (p = 0.04) but not for the other directions or rotations (p > 0.05). Conclusions: The results demonstrate that both methods are accurate, and postoperative results matched the virtually planned position precisely. It can be assumed that the described CPDs are beneficial when a condylar position different from the preoperative is desired.