Biological evaluation of an apatite-mullite glass-ceramic produced via selective laser sintering

The biological performance of a porous apatite-mullite glass-ceramic, manufactured via a selective laser sintering (SLS) method, was evaluated to determine its potential as a bone replacement material. Direct contact and extract assays were used to assess the cytotoxicity of the material. A pilot animal study, implanting the material into rabbit tibiae for 4 weeks, was also carried out to assess in vivo bioactivity. The material produced by SLS did not show any acute cytotoxic effects by either contact or extract methods. There was no evidence of an apatite layer forming on the surface of the material when soaked in SBF for 30 days, suggesting that the material was unlikely to exhibit bioactive behaviour in vivo. It is hypothesized that the material was unable to form an apatite layer in SBF due to the fact that this glass-ceramic was highly crystalline and the fluorapatite crystal phase was relatively stable in SBF, as were the two aluminosilicate crystal phases. There was thus no release of calcium and phosphorus and no formation of silanol groups to trigger apatite deposition from solution within the test time period. Following implantation in rabbit tibiae for 4 weeks, bone was seen to have grown into the porous structure of the laser-sintered parts, and appeared to be very close to, or directly contacting, the material surface. This result may reflect the local environment in vivo compared to that artificially found with the in vitro SBF test and, furthermore, confirms previous in vivo data on these glass-ceramics.