Biological Safety Assessment Of The Machinable Bioactive Glass-ceramic

To evaluate the biological safety of the machinable bioactive glass - ceramic which was manufactured recently, and provide a sound scientific basis for dental clinical practice.METHODSAccording to ISO/TR7405 , a series of tests, including acute systemic toxic-ity test, haemolysis test and micronucleus test were conducted to examine the a-cute systemic toxicity,the blood compatibility and the potential mutagenicity of the machinable bioactive glass - ceramic.RESULTSIn acute systemic toxicity test, there were no significant difference on the change of rats' avoirdupois between experimental group and negative group (P > 0.05) ; there were significant difference on the change of rats' avoirdupois between experimental group and positive group (P <0. 05) ;the tissue in rats'liver or kidney showed no evident pathologic change in both experimental group and negative group under both the light microscope and the electron microscope;but the tissue in rats'liver and kidney showed evident pathologic changes in positive group under both the light microscope and the electron microscope. In haemolysis test, the haemolysis rate of this material was 2. 30% (less than 5% ) , an index of good blood compatibility. In micronucleus test, there were no significant difference on the rate of the micronucleus between experimental group and negative group (P >0. 05 >0.017) ; there were significant difference on the rate ofthe micronucleus between experimental group and positive group (P <0.01 < 0.017).CONCLUSIONThe machinable bioactive glass - ceramic showed good biocompatibility and was noted biological safety in dental clinical application.