Efficacy and safety of biodegradable osteofixation devices in oral and maxillofacial surgery: a systematic review.

The use of osteofixation devices should be evidence-based if uncomplicated bone healing is to be achieved. Numerous studies describe and claim the advantages of biodegradable over titanium devices as a bone fixation method. Here, we systematically review the available literature to determine the clinical efficacy and safety of biodegradable devices compared with titanium devices in oral and maxillofacial surgery. In addition, related general aspects of bone surgery are discussed. We conducted a highly sensitive search in the databases of MEDLINE (1966-2005), EMBASE (1989-2005), and CENTRAL (1800-2005) to identify eligible studies. Eligible studies were independently evaluated by two assessors using a quality assessment scale. The study selection procedure revealed four methodologically 'acceptable' articles. Owing to the different outcome measures used in the studies, it was impossible to perform a meta-analysis. Therefore, the major effects regarding the stability and morbidity of fracture fixation using titanium and biodegradable fixation systems were qualitatively described. Any firm conclusions regarding the fixation of traumatically fractured bone segments cannot be drawn, due to the lack of controlled clinical trials. Regarding the fixation of bone segments in orthognathic surgery, only a few controlled clinical studies are available. There does not appear to be a significant short-term difference between titanium and biodegradable fixation systems regarding stability and morbidity. However, definite conclusions, especially with respect to the long-term performance of biodegradable fixation devices used in maxillofacial surgery, cannot be drawn.