Dental Information
 



 

The Safety of Dental Amalgam

On October 23, 2000, the Chicago Tribune carried an article written by the President of the American Dental Association in response to an Oct. 6 Letter to the Editor on mercury from amalgams.  The article is below:

By Richard F. Mascola, D.D.S.,

President, American Dental Association

CHICAGO—“An Oct. 6 letter provided readers with many untruths about dental amalgam.  The American Dental Association wants readers to know the facts about the safety and effectiveness of dental amalgam, which has been used to restore the teeth of more than 100 million Americans

Dental amalgam has an extensive safety record. Its mixture of metals such as silver, copper and tin, in addition to mercury, which chemically binds these components into a hard, stable and safe substance, has been extensively reviewed.

For example, the U.S. Public Health Service issued a report in 1993 stating there is no health reason not to use amalgam, except in the extremely rare case of the patient who is allergic to a component of amalgam. This supports the findings of the Food and Drug Administration, the National Institutes of Health Technology Assessment Conference and the National Institutes of Dental Research, that dental amalgam is a safe and effective restorative material.

In 1991, the FDA’s Dental Products Panel found there was no scientific or health reason to remove amalgam fillings. Moreover the U.S. Public Health Service found in 1993 “no persuasive reason to believe that avoiding amalgams or having them removed will have a beneficial effect on health.” In fact, removing amalgams unnecessarily can cause structural damage to health teeth.

We also want readers to know that the American Dental Association supports ongoing research in the development of new filling materials, which it hopes will someday prove to be as safe and effective as dental amalgam. Current alternatives, such as composite resins, have not been as effective as dental amalgam in providing a durable, cost-efficient and long-lasting restoration, especially in the case of large fillings.”

To respond to this letter see: http://www.chicago.tribune.com/interact/letters/letted.htm 

The Amalgam Controversy: An Evidence-Based Analysis

John E. Dodes, D.D.S.

JADA March 2001, page 348

http://www.ada.org/prof/pubs/jada/archives/0103/ab-6.html

http://www.ada.org/prof/pubs/jada/0103/ab-6.html

 

Background. There are a number of patients and health care professionals who believe dental amalgam restorations are a factor in a host of diseases and conditions. They have been influenced by anecdotal case reports in the medical and dental literature, research published in the refereed literature and media stories concerning the alleged dangers of amalgam restorations.

Methods. The author uses an evidence-based approach in analyzing the data both supporting and condemning the continued use of amalgam restorations. He reviewed the articles from both peer-reviewed and non–peer-reviewed sources and evaluated their relevance, research design and statistical analysis, as well as whether the conclusions follow from the data.

Conclusions. There are numerous logical and methodological errors in the antiamalgam literature. The author concludes that the evidence supporting the safety of amalgam restorations is compelling.

Clinical Implications. Amalgam restorations remain safe and effective. Dentists should educate patients and other health care professionals who may be mistakenly concerned about amalgam safety.

For the complete article, see the March issue of JADA.

 

While the above may constitute the ADA's stated public opinion on the use and safety of dental amalgam, to see what the organization says when asked to defend amalgam in a court of law, see Amalgam and the ADA

http://www.qualitydentistry.com/dental/amalgam/amalgam4.html

Dental Amalgam: 150 years of Safety and Effectiveness 

bulletUsed for more than 150 years, dental amalgam (a.k.a. silver filling) is a safe, affordable and durable material 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 chemically binds these components into a hard, stable and safe substance.
bulletDental amalgam has an indisputable safety record and has been extensively reviewed. The U.S. Public Health Service issued a report in 1993 stating there is no health reason not to use amalgam, except in the extremely rare case of the patient who is allergic to a component of amalgam. This supports the findings of the Food and Drug Administration, the National Institutes of Health Technology Assessment Conference and the National Institutes of Dental Research, that dental amalgam is a safe and effective restorative material. In addition, in 1991, Consumer Reports noted that "given their solid track record...amalgam fillings are still your best bet."
bulletPeople are exposed to more total mercury from food, water and air than from the minuscule amounts of mercury vapor generated from amalgam fillings.
bulletThere is no scientific evidence that exposure to mercury from amalgam restorations poses a serious health risk in humans, except for the exceedingly small number of allergic reactions. In 150 years of use, there have only been 100 documented cases of allergic reactions to amalgam in dental literature.
bulletIn 1991, the FDA's Dental Products Panel found there was no reason to remove amalgam fillings. The U.S. Public Health Service found in 1993 "no persuasive reason to believe that avoiding amalgams or having them removed will have a beneficial effect on health." In fact, it is inadvisable to have amalgams removed unnecessarily because it can cause structural damage to healthy teeth.
bulletClaims that the removal of amalgam leads to recovery from multiple sclerosis or that the use of amalgam leads to arthritis or Alzheimer's disease are unsubstantiated and without scientifically established cause and effect.
bulletThe ADA supports ongoing research in the development of new materials that it hopes will someday prove to be as safe and effective as dental amalgam. Current alternatives, such as composite resins, have not been as effective as dental amalgam in providing a durable and long- lasting restoration, especially in the case of large fillings.
bulletThe ADA concurs with the findings of the U.S. Public Health Service that amalgam has "continuing value in maintaining oral health."
bulletA recent study of approximately 1,700 dentists reported in the November 1995 issue of the Journal of the American Dental Association (JADA) concludes that dentists are now less exposed to mercury in their practices, as indicated by dropping levels of mercury concentrations found during urinary screenings, due to increased use of precautions as they create and apply dental amalgams.

Amalgam Use and Benefits

Dental amalgam, in widespread use for over 150 years, is one of the oldest materials used in oral health care. Its use extends beyond that of most drugs, and is predated in dentistry only by the use of gold. Dental amalgam is the end result of mixing approximately equal parts of elemental liquid mercury (43 to 54 percent) and an alloy powder (57 to 46 percent) composed of silver, tin, copper, and sometimes smaller amounts of zinc, palladium, or indium.

Because of a general decline of dental caries among school children and young adults, the use of dental amalgam began to decrease in the 1970s. There are also changes in patterns of dental caries, largely the result of topical and systematic fluoride, sealant use, improved oral hygiene practices and products and possibly dietary modifications. In 1990, over 200 million restorative procedures were provided in the United States; of these, dental amalgam accounted for roughly 96 million, a 38 percent reduction since 1979. This trend is expected to continue.

There are also reports that carious lesions today are generally smaller, easier to treat, and managed by more conservative treatment that retains tooth structure. Because of this decrease in the frequency and size of dental caries, there has been a relative increase in the use of alternative dental restorative materials. The most commonly used and less expensive of the alternate materials, however, cannot be used for large lesions and need more frequent replacement. Also, there are currently many serviceable dental amalgam restorations that will need replacing in the future. Approximately 70 percent of the resotrations placed annually are replacements. Most of these replacements will require amalgam or other metallic materials, because compositie materials often lack sufficient strength or durability to be considered adequate substitutes.

Today, dental amalgam is used in the following situations:
bulletin individuals of all ages,
bulletin stress-bearing areas and in small-to moderate-sized cavities in the posterior teeth,
bulletwhen there is severe destruction of tooth structure and cost is an overriding consideration,
bulletas a foundation for cast-metal, metal-ceramic, and ceramic restorations,
bulletwhen patient commitment to personal oral hygiene is poor,
bulletwhen moisture control is problematic with patients,
bulletwhen cost is an overriding patient concern.
It is not used when:
bulletesthetics are important, such as in the anterior teeth and in lingual endodontic-access (root canal) restorations of the anterior teeth,
bulletpatients have a hisotry of allergy to mercury or other amalgam components,
bulleta large restoration is needed and the cost of other restorative materials is not a significant factor in the treatment decision.

Highlights of the Report on Dental Amalgam

Dental amalgam has been used as a dental restorative material for over 150 years. Amalgam remains popular because it is strong, durable and relatively inexpensive. Roughly 200 million restorative procedures performed in 1990 used amalgam. Nonetheless, amalgam use is declining because the incidence of caries is decreasing and because improved substitute materials are now available for certain applications.

Dental amalgam, an inter-metallic compound, contains elemental mercury that is emitted in minute amounts as vapor. Because vapor emitting from amalgam restorations can be absorbed by the patient through inhalation, ingestion, or by other means, concerns have been raised about possible toxicity. At present, there is scant evidence that the health of the vast majority of people with amalgam is compromised, nor that removing amalgam filings has a beneficial effect on health. It also is recognized that a total conversion from dental amalgam to alternative materials would cause a significant increase in U.S. health care costs. Nonetheless, the possiblity that this material, as well as currently available alternatives, could pose health risks cannot be totally ruled out because of the paucity of definitive human studies.

Given the limitations of existing scientific data, a research program should be designed and implemented to fill as many gaps as possible in current knowledge about the potential long-term biological effects of dental amalgam and alternative restorative materials. The Public Health Service (PHS) should be a leader in this effort.

The PHS should also educate dental personnel and consumers about the risks and benefits of dental amalgam. An educational program should include information on all restorative materials to help dentists and their patients make informed dental treatment decisions, and encourage dental care providers to report adverse reactions. Such a program should promote the use of preventative measures such as fluoride and dental sealants to prevent caries and thus further reduce the need for dental restorations.

To exert greater control over dental amalgam use, the Food and Drug Administration (FDA) should regulate elemental mercury and dental alloy as a single product. To help dentists identify patients who may exhibit allergic hypersensitivity to all restorative materials, including dental amalgam, the FDA should require manufacturers to disclose the ingredients of these materials in product labeling.

Sweden, Denmark, and Germany have proposed restrictions on dental amalgam use to diminish both human exposure to and environmental release of mercury and not because of any documented health effects associated with exposure to dental amalgam.

The U.S. Public Health Service believes it is inappropriate at this time to recommend any restrictions on the use of dental amalgam, for several reasons. First, current scientific evidence does not show that exposure to mercury from amalgam restorations poses a serious health risk in humans, except for an exceedingly small number of allergic reactions. Second, there is insufficient evidence to assure the public that components of alternative restorative materials have fewer potential health effects than dental amalgam including allergic-type reactions. Third, there are significant efforts underway in the U.S. to reduce the amount of mercury in the environment.   And finally, as stated previously, amalgam use is declining due to a lessening of the incidence of dental caries and the increasing use of alternative materials.

 

ADA Statement on Dental Amalgam

Revised Oct 14, 2002

http://www.ada.org/prof/prac/issues/statements/amalgam.html

Dental amalgam (silver filling) 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 chemically 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.

Issued in late 1997, the FDI World Dental Federation and the World Health Organization consensus statement on dental amalgam stated, "No controlled studies have been published demonstrating systemic adverse effects from amalgam restorations." The document also states 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."

The ADA’s Council on Scientific Affairs’ 1998 report on its review of the recent scientific literature on amalgam states: "The Council concludes that, based on available scientific information, amalgam continues to be a safe and effective restorative material." The Council’s report also states, "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 association 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."

The U.S. Public Health Service issued a report in 1993 stating there is no health reason not to use amalgam, except in the extremely rare case of the patient who is allergic to a component of amalgam. This supports the findings of the Food and Drug Administration (FDA), the National Institutes of Health Technology Assessment Conference and the National Institute of Dental and Craniofacial Research, that dental amalgam is a safe and effective restorative material. In addition, in 1991, Consumer Reports noted, "Given their solid track record . . . amalgam fillings are still your best bet."

In 1991, the FDA’s Dental Products Panel found no valid data to demonstrate clinical harm to patients from amalgams or that having them removed would prevent adverse health effects or reverse the course of existing diseases. The FDA's most recent reaffirmation of amalgam's safety was published in March 2002.

The reaffirmation reads, “FDA and other organizations of the U.S. Public Health Service (USPHS) continue to investigate the safety of amalgams used in dental restorations (fillings). However, no valid scientific evidence has ever shown that amalgams cause harm to patients.”

It continues, “Also, USPHS scientists analyzed about 175 peer-reviewed studies submitted in support of three citizen petitions received by FDA after the 1993 report. They concluded that data in these studies did not support claims that individuals with dental amalgam restorations will experience problems, including neurologic, renal or developmental effects, except for rare allergic or hypersensitivity reactions.”

The U.S. Public Health Service found in 1993 "no persuasive reason to believe that avoiding amalgams or having them removed will have a beneficial effect on health." In fact, it is inadvisable to have amalgams removed unnecessarily because it can cause structural damage to healthy teeth.

The ADA supports ongoing research in the development of new materials that it hopes will someday prove to be as safe and effective as dental amalgam. However, the ADA continues to believe that amalgam is a valuable, viable and safe choice for dental patients and concurs with the findings of the U.S. Public Health Service that amalgam has "continuing value in maintaining oral health."