Dental Amalgams: Overview

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Modified on 2009/10/14 21:52 by admin
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 with dental restorations. FDA is aware that some manufacturers have advised in their labeling against using amalgams in very young children and pregnant or nursing women.

The safety of dental amalgams has been reviewed extensively over the past ten years, both nationally and internationally. In 1994, an international conference of health officials concluded there is no scientific evidence that dental amalgam presents a significant health hazard to the general population, although a small number of patients had mild, temporary allergic reactions. The World Health Organization (WHO), in March 1997, reached a similar conclusion. They wrote: "Dental amalgam restorations are considered safe, but components of amalgam and other dental restorative materials may, in rare instances, cause local side effects or allergic reactions. The small amount of mercury released from amalgam restorations, especially during placement and removal, has not been shown to cause any other adverse health effects." Similar conclusions were reached by the USPHS, the European Commission, the National Board of Health and Welfare in Sweden, the New Zealand Ministry of Health, Health Canada and the province of Quebec.

In January 1993, the USPHS published a broad scientific report about the safety and use of dental amalgam and other materials commonly used to fill dental cavities. These conclusions were reaffirmed by USPHS in 1995 and 1997. Since then, the National Institutes of Health (NIH), the Centers for Disease Control and Prevention (CDC), and the Food and Drug Administration (FDA) have continued to study the issue. The National Institute of Dental & Craniofacial Research at NIH has also provided money to study the safety of dental amalgams and to develop non-mercury alternatives. This effort includes research and clinical studies of dental amalgam use in children. These studies are ongoing and will require several years of follow-up in order to detect possible subtle and long-range health effects.

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.

Although there is international agreement that the scientific data do not confirm the presence or absence of a significant health hazard, several countries and the state of California restrict the use of dental amalgams or have recommended limitations on their use. Some manufacturers now include these "contraindications" (against using) in their labeling of dental amalgams sold in those countries. If a manufacturer wishes to make a similar labeling change in its dental amalgam sold in the United States, FDA will require the manufacturer to submit a new marketing application with data supporting the change.

FDA plans to uniformly regulate dental mercury, amalgam alloy, and pre-encapsulated dental amalgam. To reduce allergic reactions from restorative materials, FDA will propose in labeling guidance that the product's labeling list the ingredients in descending order of weight by percentage and include lot numbers, appropriate warnings and precautions, handling instructions and expiration dating. The labeling guidance will be most useful with new restorative materials.

While research, regulatory changes, and educational efforts are underway, the use of dental amalgams in the U.S. is declining. Pediatric dentists, in particular, are using resin (plastic); tooth-colored materials that are bonded to the tooth may release fluoride and are mercury-free. Other reasons for the decline in amalgam use include increasing use of sealants and community fluoridation, an expanding selection of fluoride-containing dental products, improved oral hygiene practices, and greater access to dental care.

For the foreseeable future, the patients with amalgam dental fillings will continue. The USPHS will continue gathering data about possible risks of dental amalgams and other restorative products and pursuing new methods of dental treatment and oral health. As an important part of this plan, USPHS will continue working with the dental profession to bring about changes in the delivery of oral healthcare based on valid scientific research.

See Also

  1. Medical Devices & Implants
  2. Allergies: Overview
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