Efficacy of biodegradable osteofixation devices in oral and maxillofacial surgery remains inconclusive

Medline (1966-2005), Embase (1989-2005) and (CENTRAL) Cochrane Central Register of Controlled Trials (1800-2005) were searched. Several experts were contacted to ensure that eligible studies were not overlooked. Key journals were searched by hand, together with reference lists of all relevant articles. No language restrictions were applied.

For inclusion, an article had to satisfy the following criteria. It should be a controlled clinical trial, and there should be union/ non-union of fracture or osteotomy in the maxillofacial skeleton; the presence of wound healing/ infection; intervention with a biodegradable or titanium osteofixation device; well-established (by clinical and radiographic evaluation) diagnoses and indications for treatment; and a follow-up period of >6 months.

Eligible studies were independently evaluated by two assessors using a quality assessment scale which was developed by Sindhu et al.(1) The scale consists of 53 items in 15 dimensions. Agreement regarding the weighting of the individual subdimensions and the required minimum values for each dimension was reached in a consensus meeting.

The search identified 240 articles, of which five met the inclusion criteria. Three studies were randomised controlled trials whereas the other two were quasi-randomised. There was no significant difference between biodegradable and titanium osteofixation devices with regard to short-term outcome, complication rate and infections in orthognathic surgery. Regarding the fixation of traumatically fractured bone segments, no firm conclusion could be drawn because of the lack of controlled clinical trials. It was not possible to perform a meta-analysis because of the different outcomes used in the studies.

Definite conclusions regarding the long-term performance of biodegradable fixation devices used in maxillofacial surgery cannot be drawn.