Patient discomfort and other side effects after bilateral sagittal split osteotomy or distraction osteogenesis of the mandible: a randomized clinical trial.

A randomized clinical trial was conducted to compare bilateral sagittal split osteotomy (BSSO) with distraction osteogenesis (DO) for the advancement of the mandible, with a focus on patient discomfort, postoperative pain, the need for analgesics, and occurrence of infection. All patients were non-syndromal, had a class II hypoplastic mandible, and had not undergone previous mandibular surgery. A total of 66 patients were allocated randomly to the BSSO group (32 patients) or the DO group (34 patients). Sixty-three patients were eligible for evaluation, 29 in the BSSO group and 34 in the DO group. Patients in the DO group experienced more pain after 6 days postoperative, and were administered more analgesics after 5 days postoperative than patients in the BSSO group (P=0.030 and P=0.045, respectively). The operating time was significantly shorter for the BSSO group than for the DO group (78 min vs. 100 min, P=0.024). All postoperative infections (12 in total) emerged in the DO group (P=0.005). All patients in the DO group had a second surgery in day care to remove the distractor, while two patients in the BSSO group needed plate removal. It is concluded that patients experienced more pain after DO, needed more analgesics postoperatively, and had more infections in comparison to the BSSO group.

RCT Entities:   Population Interventions Outcomes