The American Dental Association (ADA) welcomes the call by a U.S. Food and Drug Administration (FDA) panel for additional review of scientific studies on the safety of dental amalgam fillings.
“The more well-designed studies that are considered, the better the pool of evidence for making treatment recommendations to patients,” states American Dental Association Executive Director, James B. Bramson, D.D.S. “First and foremost, we want scientific evidence to lead the way when it comes to health care treatment.”
While other dental fillings materials are also available, dental amalgam remains a valued option due to 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 supports the safety and efficacy of dental amalgam, and it should continue to be made available to dentists and their patients, the ADA states.
Background information:
The ADA provided written testimony to the Sept. 6-7 FDA panel meeting reaffirming its position that dental amalgam is a safe and effective cavity-filling material based on already published scientific studies.
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.
Recent publication of two well-designed, multi-year clinical trials (the Children’s Amalgam Trials) provided the FDA panel with additional 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.
In a periodic review of the dental filling material, the FDA 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. Dental amalgam has been used for generations to fill decayed teeth that might otherwise have been lost to decay. For additional information about dental fillings, please visit the American Dental Association’s Web site at: http://www.ada.org/public/topics/fillings.asp