Stability and morbidities of Le Fort I osteotomies with bioresorbable fixation - a randomized controlled trial

Abstract

INTRODUCTION: A randomized controlled clinical trial was conducted to compare bioresorbable with titanium mini-plates and screws in Le Fort I maxillary osteotomies for evaluation of clinical morbidities and stability. METHODS: Fourty patients requiring Le Fort I osteotomies were randomly assigned to 2 groups. One group received bioresorbable mini-plate fixation and the other received titanium 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 morbidities was evaluated prospectively. RESULTS: There were no differences in complications between the two groups. Maxillae with bioresorbable fixation were significantly more mobile at the second post-operative week. Bioresorbable plates were initially more easily palpable, but palpability decreased with time. Titanium plates became significantly palpable at the 1-year follow-up period. There was no difference in neurosensory disturbance. Maxillae with bioresorbable plate fixation showed significantly more upward displacement from the 2−6th post-operative week. The horizontal and angular relapses in the 2 groups were comparable. Bioresorbable fixation in Le Fort I osteotomy produces no more morbidities. CONCLUSIONS: Bioresorbable plate fixation is confirmed to be an acceptable alternative to l titanium mini-plate fixation in Le Fort I osteotomy. There were no significant differences in morbidities in the first year following the operation. The Le Fort I maxilla with bioresorbable fixation is expected to be slightly mobile within the first 6 post-operative weeks with associated superior displacement. The long-term stability of in horizontal and vertical planes was similar.