Evaluating a Custom 3D-Printed Appliance Versus Manual Method for Mandible Positioning in Sagittal Split Ramus Osteotomy

What this Trial Is About

This research aims to evaluate the clinical effectiveness and accuracy of a custom-made proximal segment positioning appliance for use in sagittal split ramus osteotomy SSRO, a surgery to correct mandibular deformities. The study compares this new patient-specific appliance made by digital design and 3D printing with the conventional manual positioning method used by surgeons. It will include 30 adult patients undergoing SSRO or double-jaw surgery for dentofacial deformities, providing important evidence on the reliability of these custom devices in orthognathic surgery. Participants will have the custom appliance applied to one side of the mandible during surgery, while the opposite side will be positioned manually without the guide. This within-subject design allows direct comparison by eliminating differences between individuals. The appliance is designed using STL-based digital planning software and printed using biocompatible surgical resin. The surgeries may include SSRO alone or combined with Le Fort I osteotomy. During the study, postoperative CBCT scans will be taken one month after surgery and converted to 3D models to compare actual segment positioning with the preoperative plan. Researchers will also measure surgical time, rate the ease of use of the appliance, and assess any postoperative temporomandibular joint symptoms. Statistical analyses will evaluate differences, and the results will help determine the potential benefits of patient-specific surgical guides in improving accuracy and reducing complications.

Patient-Specific vs. Conventional Positioning in Sagittal Split Ramus Osteotomy