ADA AmGricsn 211 East chica9 A^nue

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1 Microsoft Word - Dental Amalgam What Others Say final... ADA AmGricsn 211 East chica9 A^nue Chicago, Illinois F vvwvv.ada.org Association America's leading advocate for oral health 'What Others Say" About Dental Amalgam Last Updated: March 27, 2O13 Alzheimer's Association: "According to the best available scientific evidence, there is no relationship between silver dental fillings and Alzheimer's.... Many scientists consider these studies compelling evidence that dental amalgam is not a major risk factor for Alzheimer's disease": 1) March 1991, the Dental Devices Panel of the FDA concluded there was no current evidence that amalgam poses any danger 2) National Institutes of Health (NIH) in 1991 funded a study at the University of Kentucky to investigate the relationship between amalgam fillings and Alzheimer's. Analysis by University statisticians revealed no significant association between silver fillings and Alzheimer's; 3) October 30, 2003, a New England Journal of Medicine article concluded that current evidence shows no connection between mercury-containing dental fillings and Alzheimer's or other neurological diseases. The abstract for this study is posted on the New England Journal of Medicine Web site. Source: disease myths about alzheimers.asp American Academy of Pediatrics: "Although dental amalgams are a source of mercury exposure and are associated with slightly higher urinary mercury excretion, there is no scientific evidence of any measurable clinical toxic effects other than rare hypersensitivity reactions. An expert panel for the National Institutes of Health has concluded that existing evidence indicates dental amalgams do not pose a health risk and should not be replaced merely to decrease mercury exposure." Source: Autism Society of America: "There is no known single cause for autism, but it is generally accepted that it is caused by abnormalities in brain structure or function. Brain scans show differences in the shape and structure of the brain in children with autism versus neuro-typical children. Researchers are investigating a number of theories, including the link between heredity, genetics and medical problems. In many families, there appears to be a pattern of autism or related disabilities, further supporting a genetic basis to the disorder. While no one gene has been identified as causing autism, researchers are searching for irregular segments of genetic code that children with autism may have inherited. It also appears that some children are born with a susceptibility to autism, but researchers have not yet identified a single "trigger" that causes autism to develop." Source: Iof3 3/29/2013 7:08 AM

2 Microsoft Word - Dental Amalgam What Others Say ISfinaL... U.S. Environmental Protection Agency: "Since the 1990s, several federal agencies have reviewed the scientific literature looking for links between dental amalgam and health problems. According to the Centers for Disease Control and Prevention (CDC), there is little scientific evidence that the health of the vast majority of people with dental amalgam is compromised, nor that removing amalgam fillings has any beneficial effect on health." Source: Mayo Clinic: "Amalgam fillings are safe. A great deal of research has examined these fillings and found them to be an effective, long-lasting treatment for dental decay. Amalgam, or silver, fillings are made with mercury, silver, tin and copper. In some cases, other metals may be included in amalgam fillings, too. Amalgam has been used for many years to replace decayed areas within teeth. It's an excellent material for this purpose. Amalgam is a strong, stable substance that holds up well when placed in a moist environment. It's also a good choice because it can tolerate the dramatic changes in temperature within your mouth." Source: "Amalgam is a safe and durable choice for fillings" in Medical Edge from Mayo Clinic January 28, National Multiple Sclerosis Society: "There is no scientific evidence to connect the development or worsening of MS with dental fillings containing mercury, and therefore no reason to have those fillings removed. Although poisoning with heavy metals-such as mercury, lead, or manganese-can damage the nervous system and produce symptoms such as tremor and weakness, the damage is inflicted in a different way than occurs in MS and the process is also different." Source: alternatlve-medlclne/lndex.aspx "There have been claims over the years that mercury leaking from amalgam dental fillings damages the immune system and causes a broad range of diseases, including MS. While the cause of MS remains unknown, there is no scientific evidence that heavy metal poisoning is responsible for either the onset or worsening of MS. There is no reason to have your dental fillings removed or replaced. This is a very expensive procedure with no proven benefit for people with MS." Source: "Dental Health" brochure U.S. Food and Drug Administration: "FDA has reviewed the best available scientific evidence to determine whether the low levels of mercury vapor associated with dental amalgam fillings are a cause for concern. Based on this evidence, FDA considers dental amalgam fillings safe for adults and children ages 6 and above. The amount of mercury measured in the bodies of people with dental amalgam fillings is well below levels associated with adverse health effects... FDA concludes that the existing data support a finding that infants are not at risk for adverse health effects from the breast 2 of 3 3/29/2013 7:08 AM

3 Microsoft Word - Dental Amalgam What Others Say final... milk of women exposed to mercury vapor from dental amalgam. The estimated daily dose of mercury vapor in children under age 6 with dental amalgams is also expected to be at or below levels that the EPA and CDC consider safe." Source: ml71094.htm New England Journal of Medicine: "Current concern arises from claims that long-term exposure to low concentrations of mercury vapor from amalgams either causes or exacerbates degenerative diseases such as amyotrophic lateral sclerosis, Alzheimer's disease, multiple sclerosis, and Parkinson's disease. Speculation has been most intense with respect to Alzheimer's disease after a report that the brains of patients with Alzheimer's disease had elevated mercury concentrations. However, several epidemiological investigations failed to provide evidence of a role of amalgam in these degenerative diseases... Patients who have questions about the potential relation between mercury and degenerative diseases can be assured that the available evidence shows no connection." Source: New England Journal of Medicine 349; 18, October 30, 2003, pp I nternational Journal of Dentistry: "According to the available articles and data reviewed in this paper, the following conclusions can be drawn: 1) Mercury released from dental amalgam restorations does not contribute to systemic disease or systemic toxicological effects, 2) Allergic reactions to mercury from dental amalgam restorations have been demonstrated, but these are extremely rare, and 3) Available scientific data do not justify the discontinuation of dental amalgam use from clinical practice or the replacement with other single-tooth restorative dental materials." Source: "Biocompatibility of Dental Amalgams" November National Council Against Health Fraud: "The National Council Against Health Fraud believes that amalgam fillings are safe..." "There is no logical reason to worry about the safety of amalgam fillings." Source: National Council Against Health Fraud Web site The National Institute of Dental and Craniofacial Research (NIDCR - part of the National Institutes of Health): "Both studies one conducted in Europe, the other in the United States independently reached the conclusion: Children whose cavities were filled with dental amalgam had no adverse health effects. The findings included no detectable loss of intelligence, memory, coordination, concentration, nerve conduction, or kidney function during the 5-7 years the children were followed." Source: Studies Evaluate Health Effects of Dental Amalgam Fillings in Children PR htm 3of3 3/29/2013 7:08 AM

4 Statement on Dental Amalgam - American Dental Association - ADA.org ADA Council on Scientific Affairs Dental amalgam is considered a safe, affordable and durable material that has been used to restore the teeth of more than 100 million Americans. It contains a mixture of metals such as silver, copper and tin, in addition to mercury, which binds these components into a hard, stable and safe substance. Dental amalgam has been studied and reviewed extensively, and has established a record of safety and effectiveness. The FDI World Dental Federation and the World Health Organization concluded in a 1997 consensus statement1: "No controlled studies have been published demonstrating systemic adverse effects from amalgam restorations." Another conclusion of the report stated that, aside from rare instances of local side effects of allergic reactions, "the small amount of mercury released from amalgam restorations, especially during placement and removal, has not been shown to cause any... adverse health effects." In 1998 the ADA'S Council on Scientific Affairs" published its first major review of the scientific literature on dental amalgam which concluded that "based on available scientific information, amalgam continues to be a safe and effective restorative material." The Council's report also stated, "There currently appears to be no justification for discontinuing the use of dental amalgam." In an article"' published in the February 1999 issue of the Journal of the American Dental Association, researchers report finding "no significant assoaation of Alzheimer's Disease with the number, surface area or history of having dental amalgam restorations" and "no statistically significant differences in brain mercury levels between subjects with Alzheimer's Disease and control subjects." A 2003 paper published in the New England Journal of Medicine" states, "Patients who have questions about the potential relation between mercury and degenerative diseases can be assured that the available evidence shows no connection." In 2004, an expert panel reviewed the peer-reviewed, scientific literature published from 1996 to December 2003 on potential adverse human health effects caused by dental amalgam and published a report. The review was conducted by the Life Sciences Research Office (LSRO) and funded by the National Institutes of Dental and Craniofacial Research, National Institutes of Health and the Centers for Devices and Radiological Health, U.S. Food and Drug Administration (FDA). The resulting report states that, "The current data are insufficient to support an association between mercury release from dental amalgam and the various complaints that have been attributed to this restoration material These complaints are broad and nonspecific compared to the well-defined set of effects that have been documented for occupational and accidental elemental mercury exposures. Individuals with dental amalgam-attributed complaints had neither elevated urinary mercury nor increased prevalence of hypersensitivity to dental amalgam or mercury when compared with controls." The full report is available from LSRO ( A summary of the review is published in Toxicological Reviews." In 2006, the Journal of the American Medical Association (JAMA) and Environmental Health Perspectives published the results of two independent clinical trials designed to examine the effects of mercury release from amalgam on the central and peripheral nervous systems and kidney function. The authors concluded that "there were no statistically significant differences in adverse neuropsychological or renal effects observed over the 5-year period in children whose caries are restored using dental amalgam or composite materials";1"/" and "children who received dental restorative treatment with amalgam did not, on average, have statistically significant differences in neurobehavioral assessments or in nerve conduction velocity when compared with children who received resin composite materials without amalgam These findings, combined with the trend of higher treatment need later among those receiving composite, suggest that amalgam should remain a viable dental restorative option for children."7'" In May 2008, a Scientific Committee of the European Commission addressed safety concerns for patients, professionals and the use of alternative restorative materials.'" The committee concluded that dental amalgams are effective and safe, both for patients and dental personnel and also noted that alternative materials are not without clinical limitations and lexicological hazards. The ADA Council on Scientific Affairs prepared a comprehensive literature review (PDF) on amalgam safety that summarizes the state of the evidence for amalgam safety over the last five years (from January 2004 to April 2009). Based on the results of this review, the Council reaffirmed at its July 2009 meeting that the scientific evidence supports the position that amalgam is a valuable, viable and safe choice for dental patients. On July 28, 2009, the U.S. Food and Drug Administration (FDA) issued its final ruje on encapsulated dental amalgam classifying amalgam and its component parts, elemental mercury and powder alloy, as a class II medical device. Previously there was no classification for encapsulated amalgam, and dental mercury (class I) and alloy (class II) were classified separately. This new regulation places encapsulated amalgam in the same ' Of 2 class of devices as most other restorative materials, including composite and gold fillings. At the same time,3t(29/2013 7:07 AM

5 Statement on Dental Amalgam - American Dental Association - ADA.org medical device. Previously there was no classification for encapsulated amalgam, and dental mercury (class I) and alloy (class II) were classified separately. This new regulation places encapsulated amalgam in the same class of devices as most other restorative materials, including composite and gold fillings. At the same time, the FDA also reaffirmed the agency's position that the material is a safe and effective restorative option for patients. The CSA supports ongoing research on the safety of existing dental materials and in the development of new materials, and continues to believe that amalgam is a valuable, viable and safe choice for dental patients. Footnotes i. FDI Policy Statement/WHO Consensus Statement on Dental Amalgam. September ii. ADA Council on Scientific Affairs. Dental Amalgam: Update on Safety Concerns. J Am Dent Assoc. 1998;129: iii. SaxeSR etal. Alzheimer's disease, dental amalgam and mercury J Am Dent Assoc. 1999; 130: iv. Clarkson TW, Magos L, Myers GJ. The toxicology of mercury - Current exposures and clinical manifestations. N Engl J Med. 2003;349: v. Brownawell AM et al. The Potential Adverse Health Effects of Dental Amalgam. Toxicol Rev. 2005:24:1-10. vi. Bellinger DC, Trachtenberg F, Barregard L, Tavares M, Cemichiari E, Daniel D, McKinlay S. Neuropsychological and Renal Effects of Dental Amalgam in Children: A Randomized Clinical Trial. JAMA 2006:295: vii. Bellinger DC, Daniel D, Trachtenberg F, Tavares M, KcKinlay. Dental Amalgam Restorations and Children's Neuropsychological Function: The New England Children's Amalgam Trial. Environ Health Perspect (online 30 October 2006). viii. DeRouen TA, Martin MD, Leroux BG, Townes BD, Wfeods 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;295: ix. European Commission: Scientific Committee on Emerging and Newly Identified Health Risks. The Safety of Dental Amalgam and Alternative Dental Restoration Materials for Patients and Users May 8, 2008 (accessed June 17, 2008). 3/29/2013 7:07 AM