A prospective trial of poly-L-lactic/polyglycolic acid co-polymer plates and screws for internal fixation of mandibular fractures.

The aim of this study was to test the performance of poly-L-lactic/polyglycolic acid (PLLA/PGA) co-polymer plates and screws in the fixation of mandibular fractures. Following clinical and radiographic examination, internal fixation was achieved with PLLA/PGA co-polymer plates and screws in 31 patients. Elastic maxillomandibular fixation was maintained for 4 weeks and a blenderized diet for 6 weeks. Patients were followed up at 1 week, 6 weeks, and 3, 6 and 12 months post surgery, and evaluated clinically for swelling, pain, mucosal discoloration and occlusal relation. Segment stability, fracture healing and screw-hole ossification were assessed radiographically. Of the 29 patients who completed the trial, 20 had an uncomplicated postoperative period, resulting in complete bone union. Radiographic evidence of screw-hole ossification was noted in several patients, with considerable site-dependent rate variation. Nine patients developed complications ranging from minor dehiscence (4 patients) to frank sepsis requiring plate removal (5 patients), resulting in a 22.5% complication rate. There were no cases of non-union at the end of the fixation period. The reported complication rate following titanium internal fixation of mandibular fractures is 13.7%-43%. PLLA/PGA co-polymer plate and screw fixation of mandibular fractures, although technically more challenging and costly, is a viable alternative to traditional metal devices in selected patients.