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Overview
Last week, the American Dental Association (ADA) issued a news release welcoming an FDA advisory panel’s vote for additional review of scientific studies on the safety of dental amalgam. The panel vote drew extensive media coverage, and in this feature, Science in the News provides additional information on the ADA’s testimony and the FDA panel meeting.
On September 6–7, the ADA presented testimony to a joint panel of the U.S. Food and Drug Administration (FDA) on the well-established safety and effectiveness of dental amalgam as a restorative material. At the two-day meeting in Gaithersburg, Maryland, the FDA panel collected facts and opinions about dental amalgam through written testimony and oral presentations from scientific experts including three witnesses on behalf of the ADA, consumer groups, and the general public.
As a public health agency, the FDA regulates the components of dental amalgam, and periodically reviews the available literature to determine if exposure to dental amalgam poses potential health risks to humans. At last week’s meeting, the FDA advisory panel, consisting of a broad spectrum of scientific experts, requested additional information in several areas, including the impact of dental amalgam on the developing fetuses of pregnant women.
In its testimony before the FDA panel, the ADA stated that the cumulative scientific evidence confirms that dental amalgam is a safe, affordable and durable material that has been used to restore the teeth of over 100 million Americans. The ADA also noted that it does not advocate the use of one dental material over another, but rather supports the provision of safe and viable restorative options to all patients.
Dental amalgam has been studied and reviewed extensively, and has a firmly established record of safety and effectiveness as a restorative material. In addition, two recent clinical trials1, 2 did not identify any adverse health effects arising from the placement of amalgam restorations in children (additional information is available in an April 2006 “Science in the News”).
The ADA supports the role and importance of scientific evidence and its judicious integration with patient preferences and the dentist’s clinical experience. The ADA will continue to monitor the scientific literature on the safety of products commonly used in dentistry, including amalgam. The ADA also encourages research on restorative materials to ensure that the profession and the public have current, scientifically valid information on which to make choices about dental treatment. For the ADA’s written testimony to the FDA panel meeting, see the ADA news release.
Footnotes
1 DeRouen TA, Martin MD, Leroux BG, Townes BD, Woods JS, Leitao J, Castro-Caldas A, Luis H, Bernardo M, Rosenbaum G, Martins IP. Neurobehavioral effects of dental amalgam in children: a randomized clinical trial. JAMA 2006 Apr 19;295(15):1784-92.
2 Bellinger DC, Trachtenberg F, Barregard L, Tavares M, Cernichiari E, Daniel D, McKinlay S. Neuropsychological and renal effects of dental amalgam in children: a randomized clinical trial. JAMA 2006 Apr 19;295(15):1775-83.
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Science in the News is a service by the American Dental Association (ADA) to present current information about science topics in the news. The ADA is a professional association of dentists committed to the public's oral health, ethics, science and professional advancement; leading a unified profession through initiatives in advocacy, education, research and the development of standards. As a science-based organization, the ADA's evaluation of the scientific evidence may change as more information becomes available. Your thoughts would be greatly appreciated.
Page Posted September 2006
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