Background: Biodegradable implants have not been used on a large scale for internal fixation of mandibular fractures because of presumed inferior mechanical properties. This prospective clinical trial was designed to elucidate the stability and biocompatibility of self-reinforced poly-L/D-lactide plates and screws used to stabilize a variety of mandible fractures by open reduction and internal fixation.
Methods: Sixty-six consecutive patients (22 female, 44 male; mean age, 23.9 years) with a total of 89 fractures at various sites of the mandible were included in the study. Stability of plates and screws and bone healing were observed by clinical and radiographic assessment. Intermaxillary fixation was applied in eight patients with concomitant condylar fractures for 2 to 3 weeks.
Results: The self-reinforcement technique provided sufficient mechanical stability of the implants for primary healing of these high-load mandibular bone areas. Postoperative complications were transient and limited to wound dehiscence and localized wound infection (two patients). In some patients, hypesthesia (three patients) or slight pain (10 patients) was reported at the 1-year recall examination, but implant-related serious adverse tissue reactions were not observed during the follow-up (mean, 24.4 months; range 6.4 to 44.3 months).
Conclusions: On the basis of these preliminary results, the authors conclude that biodegradable self-reinforced implants show efficient stability during initial bone healing and promise a high potential for successful use in osteofixation of mandibular fractures.