Skeletal Stability of Le Fort I Osteotomy Using Patient-Specific Osteosynthesis Compared to Mini-Plate Fixation for Patients with Dentofacial Disharmony. A Randomized Controlled Clinical Trial

Abstract

Purpose: to evaluate the skeletal stability of Le Fort I osteotomy using patient-specific osteosynthesis (PSO) compared to conventional mini-plate fixation in patients with skeletal class III malocclusion undergoing bimaxillary orthognathic surgery.

Methods: A total of 24 patients with skeletal class III malocclusion indicated for bi-maxillary orthognathic surgery were randomly assigned to 2 equal parallel groups. In 12 patients, computer-aided design and manufacturing (CAD/CAM) cutting guides and customized titanium patient-specific plates (PSPs) were used (group 1 or intervention group). In the other 12 patients, classic mini-plates were used (group 2 or control group). Skeletal stability of Le Fort I osteotomy was assessed for all patients in both groups after one year using CT scan.

Results: The mean horizontal relapse of maxilla after one year was 0.59±0.26 mm in group I (PSPs) and 0.69±0.27 mm in group II (conventional mini-plates). Intergroup comparisons of change in the coronal plane showed no statistically significant difference in relapse after 1 year between the intervention and control groups for (A point, ANS, PNS, RGBF, and LGBF), while for (IF and average) the change measured in the control group was significantly higher (more horizontal relapse) than that of the intervention group.

Conclusion: Both conventional mini-plates and PSPs provided stable and reliable fixation in small (<5mm) maxillary advancements via the Le Fort I osteotomy in class III patients who underwent bimaxillary surgery, with no clinically significant difference in relapse found between conventional mini-plates and PSPs fixation after one year follow up.