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.     

No differences in infections between patient-specific implants and conventional mini-plates in mandibular bilateral sagittal split osteotomy — Up to 3-year follow-up

The use of individually designed osteotomies, combined with individually manufactured osteosynthesis material, is rapidly becoming a standard for more challenging maxillofacial surgery. The benefits of patient-specific implants (PSI) in orthognathic surgery are clear in complex cases. PSIs can enhance precision and ease up the surgical protocol. We previously reported on the benefits of PSIs as reposition and fixation systems during Le Fort I osteotomy. The aim of this study was to evaluate a cohort of 28 patients, treated with bilateral sagittal split osteotomy (BSSO) and PSIs for fixation, with regard to healing for up to 3 years. A retrospective cohort of 48 patients with conventional mini-plate repositioned mandibles was also collected for statistical analysis. No statistically significant differences were found with regard to infection, soft tissue problems, or reoperations between these two groups.