Recommendations for determining biocompatibility and safety for the clinical use of metals in dentistry.
Determining the safety of dental materials through laboratory and animal testing before widespread use of such products in humans is critical to the continued use of many materials in dentistry. The patient and the dentist have the right to expect that a manufacturer has adequately evaluated a product for safety as well as effectiveness for its intended use before making the product commercially available. Although the use of dental amalgam and casting alloys is widespread, there is insufficient documented evidence to recommend discontinuing the use of either dental amalgam or base metal casting alloys. Unless it can be shown that a patient is hypersensitive to the metal and that the hypersensitivity is indeed a causative factor in a systemic disease, replacement of existing restorations is not recommended. Nevertheless, there are specific areas of future research including actions a dentist should implement. The dentist should document cases of sensitivity to metals and become familiar with the symptoms arising from metal exposure. In screening new products for use in dentistry the FDI Technical Report No. 9, Recommended Standard Practices for Biological Evaluation of Dental Materials is relevant. The series of recommended tests for metals to be used in dentistry include initial tests to determine acute toxicity, secondary tests such as those to evaluate irritation to the tissues in contact with the metal and usage tests, i.e. tests in animals simulating intended clinical use in humans.
Stanford
J W
JW
D000818:Animals; D001672:Biocompatible Materials / Q000009:adverse effects; D003257:Consumer Product Safety; D003723:Dental Amalgam / Q000009:adverse effects / Q000592:standards; D003734:Dental Casting Investment / Q000009:adverse effects / Q000592:standards; D003764:Dental Materials / Q000009:adverse effects / Q000592:standards; D004341:Drug Evaluation; D004353:Drug Evaluation, Preclinical; D006801:Humans; D006967:Hypersensitivity / Q000209:etiology
D001672:Biocompatible Materials; D003734:Dental Casting Investment; D003764:Dental Materials; D003723:Dental Amalgam