Stability and morbidity of Le Fort I osteotomy with bioresorbable fixation: a randomized controlled trial

A randomized controlled clinical trial was conducted to compare the use of bioresorbable and titanium mini-plates and screws in Le Fort I maxillary osteotomies for evaluation of clinical morbidity and stability. Forty patients requiring Le Fort I osteotomies were randomly assigned to two groups. One group underwent bioresorbable mini-plate fixation and the other titanium mini-plate fixation. Stability of the maxilla was determined by serial cephalometric analysis at 2 and 6 weeks and at 3, 6 and 12 months postoperatively. Subjective and objective assessment of clinical morbidity was made prospectively. There were no differences in complications between the two fixation materials. Maxillae with bioresorbable fixation were significantly more mobile at the second postoperative week. Bioresorbable plates were initially more easily palpable, but their palpability decreased with time. Titanium plates became significantly more palpable at the 1-year follow-up. There was no difference in neurosensory disturbance between groups. Patients with bioresorbable plate fixation showed significantly more upward displacement in anterior maxilla following impaction and posterior maxilla following downgrafting from the 2nd to 6th postoperative week. The horizontal and angular relapses in the two groups were comparable. Le Fort I osteotomy with bioresorbable fixation results in no greater morbidity than with titanium fixation up to 1 postoperative year.