Stability of maxillary advancement for correction of skeletal Class III malocclusion after combined maxillary and mandibular procedures: preliminary results of an active control equivalence trial for semirigid and rigid fixation of the maxilla

In this paper preliminary results are presented of a prospective study designed to examine the effect of maxillary fixation methods on postoperative stability. The purpose of this study was to evaluate the stability of Le Fort I osteotomy stabilized with semirigid fixation of the maxilla (SRMF) or rigid fixation of the maxilla (RMF). All patients had skeletal Class III malocclusion and underwent bimaxillary surgery (Le Fort I maxillary advancement with or without superior repositioning and bilateral sagittal split osteotomies of the mandible). Standardized cephalometric analysis was performed on serial radiographs of 42 patients immediately before surgery, 1 week after surgery, after release of fixation, and 1 year postoperatively. The patients were randomized into 2 treatment groups: 23 patients received RMF (group A), and 19 patients received SRMF (group B). Within the groups, patients showed good stability with regard to their baseline characteristics. To show the therapeutic equivalence of the 2 treatments, analysis of the recorded data followed the approach for an equivalence trial. The mean surgical advancement was 5.34 +/- 1.50 mm for group A and 4.51 +/- 1.37 mm for group B. The mean amount of postsurgical relapse was 0.98 +/- 1.27 mm for group A and 0.30 +/- 1.04 mm for group B. Group A patients experienced 93% of their relapse (0.92 mm) during fixation, while group B patients experienced 96% of their relapse (0.29 mm) after release of fixation. RMF provided better stability than SRMF for all maxillary landmarks in the vertical plane. All considered points both in horizontal and vertical plane exhibited full equivalence for 95% confidence intervals, which seems to indicate equivalent stability between the surgical procedures.