OBJECTIVE: This multisite prospective randomized clinical trial examined 2-year longitudinal soft tissue profile changes after bilateral sagittal split osteotomy for mandibular advancement by using rigid or wire fixation, with and without genioplasty. STUDY DESIGN: The study sample consisted of 127 subjects. The rigid-fixation group (n = 78) received 2-mm bicortical position screws, whereas the wire-fixation group (n = 49) received inferior border wires. In the rigid-fixation group, 35 subjects underwent genioplasty, whereas 24 subjects underwent genioplasty in the wire-fixation group. Soft tissue profile changes of labrale inferius, B-point, and pogonion were obtained from digitized cephalometric films taken immediately before surgery and up to 2 years after surgery. RESULTS: Regardless of fixation technique, subjects who had genioplasty in conjunction with the mandibular advancement had the largest surgical movement and the largest postsurgical change (P <.05). When all variables were constant, fixation technique was associated with maintenance of soft tissue change. Subjects who underwent rigid fixation maintained more soft tissue change than patients who underwent wire fixation. CONCLUSIONS: These findings suggest that subjects undergoing rigid fixation and genioplasty maintained the most soft tissue advancement.
RCT Entities:
OBJECTIVE: This multisite prospective randomized clinical trial examined 2-year longitudinal soft tissue profile changes after bilateral sagittal split osteotomy for mandibular advancement by using rigid or wire fixation, with and without genioplasty. STUDY DESIGN: The study sample consisted of 127 subjects. The rigid-fixation group (n = 78) received 2-mm bicortical position screws, whereas the wire-fixation group (n = 49) received inferior border wires. In the rigid-fixation group, 35 subjects underwent genioplasty, whereas 24 subjects underwent genioplasty in the wire-fixation group. Soft tissue profile changes of labrale inferius, B-point, and pogonion were obtained from digitized cephalometric films taken immediately before surgery and up to 2 years after surgery. RESULTS: Regardless of fixation technique, subjects who had genioplasty in conjunction with the mandibular advancement had the largest surgical movement and the largest postsurgical change (P <.05). When all variables were constant, fixation technique was associated with maintenance of soft tissue change. Subjects who underwent rigid fixation maintained more soft tissue change than patients who underwent wire fixation. CONCLUSIONS: These findings suggest that subjects undergoing rigid fixation and genioplasty maintained the most soft tissue advancement.