Le Fort I miniplate osteosynthesis: a randomized, prospective study comparing resorbable PLLA/PGA with titanium.

The aim of this study was to compare the use of resorbable osteosynthesis material (LactoSorb) with titanium osteosynthesis for the fixation of Le Fort I osteotomies with respect to long-term stability and morbidity. To achieve exact cephalometric measures, five tantalum micro implants were inserted in the maxilla during surgery. A total of 60 patients undergoing a non-segmented Le Fort I osteotomy were randomized to one of the treatments and were followed for 1 year postoperatively. For the osteotomies fixated with LactoSorb, the lateral cephalometric analysis demonstrated a statistically significant difference in the vertical position of the maxilla after 6 weeks as the position became more superior compared with the postoperative situation (mean change of 0.6 mm). In the titanium group no significant changes in position were observed. There were no statistically significant changes in the position of the maxilla from 6 weeks to 12 months in either of the treatment groups. The changes in maxillary postion were not clinically noticeable in either of the treatment groups, and all treatments were completed with satisfactory results. There were two cases of infection and wound dehiscence in the LactoSorb group, whereas titanium osteosynthesis was more often palpable after 6-12 months and required surgical removal in three cases.

RCT Entities:   Population Interventions Outcomes