Clinical Evaluation of Resorbable Poly (L-Lactide/D-Lactide/Glycolide) Bone Fixation Devices in Orthognathic Surgery

Abstract

The clinical efficacy and safety of new resorbable plate and screw fixation devices for maxillary stabilization in orthognathic surgery were evaluated in this study. The plate and screw fixation devices were fabricated from a unique tripolymer composed of poly L-Lactide/D-Lactide/Glycolide with a molecular ratio of 85/5/10. From August 2002 to May 2003, we conducted a clinical trial, using the resorbable devices for fixation of the maxilla at osteotomy sites of thirty patients. In all patients, the fixation of bony fragments was evaluated at the time of the operation, and the postoperative course and complications were evaluated by clinical and CT findings and by blood and urine examinations for 6 months following surgery.
All patients had satisfactory results from surgery. While none of the patients had any evidence of adverse tissue reactions such as facial swelling, erythema, and/or radiographic osteolysis at 6 months after surgery, mild tenderness remained at three implantation sites in two patients in the clinical evaluation. Blood and urine examination showed no evidence of a cause-and-effect relationship between abnormal examination values and fixation devices. In radiographic evaluations at 6 months after surgery, bone adhesions were obscure in sixteen patients, but the fixations were maintained in all cases. These results of clinical and radiographic evaluations provide evidence that osteosynthesis can be safely and effectively completed in fixation of the maxilla with the resorbable plate and screw fixation devices.