Effectiveness of individualized 3D titanium-printed Orthognathic osteotomy guides and custom plates

Background: Computer-aided design/manufacturing (CAD/CAM) technology was developed to improve surgical accuracy and minimize errors in surgical planning and orthognathic surgery. However, its accurate implementation during surgery remains a challenge. Hence, we compared the accuracy and stability of conventional orthognathic surgery and the novel modalities, such as virtual simulation and three-dimensional (3D) titanium-printed customized surgical osteotomy guides and plates. Methods: This prospective study included 12 patients who were willing to undergo orthognathic surgery. The study group consisted of patients who underwent orthognathic two-jaw surgery using 3D-printed patient-specific plates processed by selective laser melting and an osteotomy guide; orthognathic surgery was also performed by the surgeon directly bending the ready-made plate in the control group. Based on the preoperative computed tomography images and intraoral 3D scan data, a 3D virtual surgery plan was implemented in the virtual simulation module, and the surgical guide and bone fixation plate were fabricated. The accuracy and stability were evaluated by comparing the results of the preoperative virtual simulation (T0) to those at 7 days (T1) and 6 months (T2) post-surgery. Result: The accuracy (ΔT1‒T0) and stability (ΔT2‒T1) measurements, using 11 anatomical references, both demonstrated more accurate results in the study group. The mean difference of accuracy for the study group (0.485 ± 0.280 mm) was significantly lower than in the control group (1.213 ± 0.716 mm) (P < 0.01). The mean operation time (6.83 ± 0.72 h) in the control group was longer than in the study group (5.76 ± 0.43 h) (P < 0.05). Conclusion: This prospective clinical study demonstrated the accuracy, stability, and effectiveness of using virtual preoperative simulation and patient-customized osteotomy guides and plates for orthognathic surgery.