On December 14-15, 2010, the U.S. Food and Drug Administration (FDA) convened an Advisory Panel to discuss several scientific issues that may affect the regulation of dental amalgam. At the conclusion of the hearing, the Panel voted to recommend that the FDA conduct further review of the material's safety.
The meeting comes on the heels of a July 2009 Final Rule from the FDA that reclassified dental mercury from a class I device to a class II device and designated special controls for dental amalgam, mercury and amalgam alloy. The 2009 ruling was the culmination of seven years of deliberation by the FDA and confirmed the safety of dental amalgam for use in all populations.
The Final Rule noted that "scientific studies using the most reliable methods have shown that dental amalgam exposes adults to amounts of elemental mercury vapor below or approximately equivalent to the protective levels of exposure identified by Agency for Toxic Substances and Disease Registry (ATSDR) and Environmental Protection Agency (EPA)."
On December 14, Dr. Mary Tavares, DMD, MPH, testified on behalf of the American Association for Dental Research (AADR) during the first day of the Advisory Panel meeting. Dr. Tavares, a Senior Investigator at the Forsyth Institute and a co-Principle Investigator on the New England Children's Dental Amalgam Trial (Bellinger DC et al), stated that "no statistically significant differences in adverse neuropsychological or renal effects were observed in children whose teeth were restored with dental amalgam compared to composite resin." The five year clinical trial, which ended in 2006, was reported in the Journal of the American Medical Association and funded by the National Institute of Dental and Craniofacial Research (NIDCR).
AADR continues to support the findings from the FDA 2009 Final Rule and the Association also supports the continual review of new scientific information regarding the safety of all dental products and materials, as it becomes available.
To see AADR's full comments to the FDA Panel, click here.
Bellinger DC, Trachtenberg F, Barregard L, Tavares M, Cernichiari E, Daniel D, McKinlay S. (2006) Neuro-psychological and renal effects of dental amalgam in children. A randomized clinical trial. J. Am. Med. Assoc. 295(15):1775-1783.
Ingrid L. Thomas
International & American Association for Dental Research