It was clear from the findings of the CCEHRP Subcommittee on Risk Assessment that additional research is needed to resolve the question of whether the mercury in dental amalgam poses any significant health risk to patients. The answer to this question would resolve the two basic public health policy issues regarding dental amalgam: whether amalgam restorations should continue to be used in the future, and whether existing restorations should be removed and replaced with other materials.
The Subcommittee on Risk Management (through an interagency Research Work Group) was charged with looking into several aspects of research on the health effects of dental amalgam. These are the group's conclusions:
- Research is needed on the specific health effects of low-level mercury exposure; on the absorption, distribution, metabolism and elimination of this material; on potential biological markers for exposure and effect; on the medical significance of such markers; and on the significance of various blood, urine, or tissue levels of mercury.
- Among the issues high on any dental amalgam research agenda would be the following: whether low-level mercury effects are prevalent in the general population, and whether these can be attributed to amalgam; which special population groups, if any (e.g., children, pregnant women, or those with renal disease), might be especially sensitive to mercury effects; how human studies could be designed to assess the potential effects of dental amalgam; whether existing amalgam should be replaced and, if so, under what circumstances; how the mercury in amalgam might be stabilized to minimize release into the body; and, how safe and effective are the existing alternatives to amalgam.
- The PHS should establish an intramural tracking mechanism to identify and monitor amalgam research projects which it funds. It should be administered by the Office of the Assistant Secretary for Health, and should also include information from relevant sister agencies such as the Environmental Protection Agency (EPA) and the Department of Defense (DOD), as well as from the private sector.
- The declining reliance on dental amalgam should be encouraged by promoting the use of dental sealants to prevent caries, and the use of alternative materials for dental restorations where clinically appropriate.
- FDA’s medical device reporting programs are not likely to be useful as a source of information for definitive scientific amalgam research. These reporting programs, although important to FDA as an early-warning system on device adverse effects, cannot quantify population risks and are often subject to various biases which limit their usefulness for research purposes.
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- The Research Work Group has compiled an inventory of existing research studies that bear upon the issue of amalgam safety (see Appendix IV). The Work Group has also identified a series of scientific questions which must be answered before a definitive conclusion can be reached on amalgam safety. This material, along with a prioritized list of research areas compiled by the Work Group, can serve as a basis for designing a targeted research program.
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