DLP: What is the difference between having 210-ppm level of lead in a porcelain compound and the release of that lead after the porcelain has been fired and placed in the mouth?


Jefferies:
Clearly there may exist significant differences in the behavior (for example, solubility) of unprocessed dental material as compared to one that has been fired or polymerized, depending on the mode of fabrication. In the case of a properly fired porcelain material, there can be a significant difference between the actual composition of a component in the bulk porcelain versus its release or availability in the oral environment. The solubility of any material may also affect the release of compositional elements and compounds. The levels of maximum solubility of various ceramic materials may exist in various national (ANSI/ADA) and international (ISO) standards, as well as various regulatory (FDA) guidance documents. So the compositional amount of a trace element in a material may be far greater than its true availability or release either on an acute or chronic basis. These factors are some of the considerations taken into account in any toxicological risk assessment in terms of the total available dose and total cumulative dose over time.


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