A portable mixed reality navigation system for oral and maxillofacial surgery: Design and preliminary clinical evaluation
Zhongjie Shi, Tianyi Li, Jianguo Ke, Jia Li, Xin Gao, Xinfeng Zhang, Xuan Wang, Yameng Si, Zhanxiang Wang · Journal of Cranio-Maxillofacial Surgery · 2025
OBJECTIVE: To develop a novel mixed reality (MR)-based portable navigation system for oral and maxillofacial surgery (OMFS) and to evaluate its feasibility and spatial accuracy in clinical applications. METHODS: The MR-based system was developed using Microsoft HoloLens 2, leveraging its built-in near-infrared cameras for reflective marker tracking. A customized software module, developed on the 3D Slicer platform, enabled automatic registration and real-time 3D anatomical visualization through a spatial pose filtering algorithm. A non-invasive patient-specific dental bracket was fabricated using silicone rubber for fixation and registration. A prospective clinical trial involving 24 patients was conducted. Navigation performance was quantitatively assessed by comparing preoperative and intraoperative registration errors, and qualitatively evaluated based on lesion overlap observed through the MR headset. RESULTS: The proposed MR system successfully achieved real-time 3D visualization and immersive intraoperative navigation without the use of external tracking devices. The mean preoperative localization error was 1.64 ± 0.78 mm, and the intraoperative error was 1.65 ± 1.00 mm (p = 0.44), indicating no significant difference. Among the 24 cases, 83.3 % demonstrated high virtual-to-actual concordance, while 16.7 % showed moderate concordance. The average data processing time was 8.38 ± 0.83 min, with improved efficiency observed over repeated trials. CONCLUSION: The MR-based navigation system demonstrated good feasibility, accuracy, and usability for OMFS procedures. Its low cost, non-invasive design, and flexibility make it a promising intelligent surgical guidance tool for routine clinical practice, particularly in primary healthcare settings.