Current views on biological testing of restorative materials.

It is anticipated that biological testing in Europe after 1 January 1993 will be based on European Standards (EN) common to all biomaterials. No details regarding the future certification programmes are yet available. In vitro cytotoxicity, tissue reactions to implanted materials and pulp studies ('usage tests') represent three levels commonly used for biological testing of restorative dental materials. Considerable variation in test methodology exists, and no universal agreement prevails with regard to which test or tests are most appropriate for evaluation of the biological effects of restorative materials. The latter also include a number of allergens, but few biological side-effects have been noted in clinical practice.