Accuracy Assessment of Customized Titanium Plates Compared to 3D-Printed Splints in Le Fort I Osteotomy: A Randomized Clinical Trial Evaluating Clinical and Radiographic Outcomes.

AIM: This study aimed to evaluate the accuracy of a personalized orthognathic surgical guide (POSG) system using customized titanium fixation plates versus 3D-printed splints for maxillary repositioning in Le Fort I osteotomy.

TRIAL

DESIGN

A randomized clinical trial with parallel-arm design and 1:1 allocation ratio with a superiority framework.

METHODS

Twelve patients requiring Le Fort I osteotomy were randomly assigned to two groups based on the surgical transfer technique: a customized titanium plate group (study group) and a 3D-printed splint group (control group). Virtual surgical planning was performed using Mimics Medical 19.0 (Materialise, Leuven, Belgium) and 3-Matic Medical 14.0 (Materialise, Leuven, Belgium) software to generate stereolithography (STL) files for cutting guides and fixation plates. Preoperative and postoperative CT scans were aligned using surface-based, landmark-free registration. Deviations from the surgical plan and postoperative CT scan were measured at selected anatomical landmarks across three reference planes: the Frankfort horizontal plane (FHP), midsagittal plane (MSP), and coronal plane (CP). Primary outcomes included the accuracy of surgical transfer. Secondary outcomes included operative time, fabrication accuracy, hardware complications, and postoperative infection.

RESULTS

There were no statistically significant differences between the virtual plan and postoperative outcomes for MSP and FHP measurements in either group (p > 0.05). However, a statistically significant difference was observed in CP measurements, with the control group showing a greater mean deviation (1.54 ± 0.28 mm) than the study group (1.08 ± 0.25 mm; p = 0.013). The mean operative time was significantly shorter in the customized plate group (126.67 ± 11.69 minutes) than in the 3D splint group (178.33 ± 15.38 minutes; p < 0.001). All patients achieved stable postoperative occlusion. One patient in the customized plate group experienced transient upper lip numbness, which resolved within two months. No plate loosening, infection, or soft tissue complications were reported.

CONCLUSION

Both customized titanium plates and 3D-printed splints accurately transferred virtual surgical plans for Le Fort I osteotomy. However, the personalized plate system showed greater precision in anteroposterior maxillary positioning. Additionally, it reduced surgical time and eliminated the need for intraoperative splint use. Further studies with larger sample sizes and standardized protocols are recommended to validate these findings and guide future clinical applications.