Postoperative skeletal stability at the one-year follow-up after splintless Le Fort I osteotomy using patient-specific osteosynthesis versus conventional osteosynthesis: a randomized controlled trial

The purpose of this study was to assess the 1-year skeletal stability of the osteotomized maxilla after Le Fort I surgery, comparing conventional osteosynthesis with patient-specific osteosynthesis. Patients were assigned to a conventional or patient-specific osteosynthesis group using prospective randomization. The primary outcome was the three-dimensional change in postoperative skeletal position of the maxilla between the 2-week and 1-year follow-up cone beam computed tomography scans. Fifty-eight patients completed the protocol for the 2-week postoperative analysis, and 27 patients completed the 1-year follow-up study protocol. Of the 27 patients completing the entire protocol, 13 were in the conventional group and 14 in the patient-specific osteosynthesis group. The three-dimensional translation analysis showed that the use of the patient-specific osteosynthesis resulted in a skeletally stable result, comparable to that of conventional miniplate fixation. For both the patient-specific osteosynthesis and conventional miniplate fixation groups, median translations of less than 1 mm and median rotations of less than 1° were observed, indicating that both methods of fixation resulted in a stable result for the 27 patients examined. For the Le Fort I osteotomy, the choice between patient-specific osteosynthesis and conventional osteosynthesis did not affect the postoperative skeletal stability after 1 year of follow-up.