ADA Testifies Before FDA On Dental Filling Safety

Main Category: Dentistry
Article Date: 06 Sep 2006 - 0:00 PDT

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In written testimony to a two-day joint panel meeting of the U.S. Food and Drug Administration (FDA), the American Dental Association (ADA) today reaffirms its position that dental amalgam is a safe and effective cavity-filling material.

According to the testimony, the ADA does not advocate for the use of one dental material over another, however it champions the principle that patients and their dentists should have access to the full range of safe and effective options for treating dental decay.

The ADA welcomes this review of the science by individuals from different disciplines. Recent publication of two well-designed, multi-year clinical trials (the Children's Amalgam Trials) will provide the panel with more evidence of amalgam's safety. These studies, published in the April issue of the Journal of the American Medical Association, compare the use of amalgam to composite dental fillings in two groups of children. The studies found no differences in I.Q. or kidney function of children with amalgam and those with composite fillings. The clinical trials' evidence as well as a number of other studies will be reviewed by the FDA joint panel.

The purpose of the FDA meeting is to gather facts and opinions. No specific regulatory action is expected to result from this hearing. In this periodic review of the dental filling material, the FDA has combined the expertise of the Dental Products Panel of the Medical Device Advisory Committee with the neurology expertise of the Peripheral and Central Nervous System Drugs Advisory Committee to consider the peer-reviewed scientific studies on dental amalgam and any potential neurotoxic effects.

Dental amalgam contains elemental mercury combined with other metals such as silver, copper, tin and zinc to form a safe, stable alloy. Because amalgam contains elemental mercury, some groups have raised concerns about its potential health effects and questioned its continued use in dentistry. Dental amalgam has been used for generations to fill decayed teeth that might otherwise have been lost to decay.

While other dental fillings materials are also available, dental amalgam remains a valued option because of its strength, durability, affordability and the fact that it can be used below the gum line, which is difficult to keep dry. Dental amalgam can be placed in a wet environment and hardens quickly, which can be critical when working with patients such as children or people with disabilities, who might have difficulty sitting still during treatment.

The overwhelming weight of scientific evidence, including the recent clinical trial results, supports the safety and efficacy of dental amalgam, and it should continue to be made available to dentists and their patients, the ADA states.

The not-for-profit ADA is the nation's largest dental association, representing more than 153,000 members. The premier source of oral health information, the ADA has advocated for the public's health and promoted the art and science of dentistry since 1859. The ADA's state-of-the-art research facilities develop and test dental products and materials that have advanced the practice of dentistry and made the patient experience more positive. The ADA Seal of Acceptance long has been a valuable and respected guide to consumer and professional products. For more information about the ADA, visit the Association's Web site at http://www.ada.org/.

ADA
http://www.ada.org/