Prepared by the Education Work Group
of the Subcommittee on Risk Management
Committee to Coordinate Environmental Health
and Related Programs

February 1992

Education Work Group Leader:
James L. Morrison, M.S. -
Food and Drug Administration

Lawrence J. Furman, D.D.S. -
Office of the Chief Dental Officer, USPHS

Lireka P. Joseph, Dr.P.H. -
Food and Drug Administration

William G. Kohn, D.D.S. -
National Institute of Dental Research

Max Lum, Ed.D. -
Agency for Toxic Substances and Disease Registry

D. Gregory Singleton, D.D.S. -
Food and Drug Administration

Despite widespread use of dental amalgam as a restorative material and the considerable amount of positive information distributed to both the public and health professionals, its safety continues to be called into question. Recently, some scientists and others have made allegations of adverse health effects associated with the use of dental amalgam. Although these allegations are not supported by the weight of scientific evidence, they have heightened public anxiety to the extent that a number of people have had or considered having their amalgam restorations removed. The lack of a definitive educational initiative by Federal health agencies may be a contributory factor to the anxiety experienced by the public.

After considering available information, the Work Group determined that educational programs were necessary and advised CCEHRP that there is a need to develop programs to:

1. Provide the public and health professionals with accurate information about the risks and benefits of dental amalgam. The Work Group believes this effort should commence with a press release from CCEHRP at the time this report is released allaying concerns and announcing that educational efforts will be forthcoming.
2. Inform the public and health professionals about safe and appropriate amalgam use and provide guidance to those considering removal of amalgam restorations and replacement with alternative materials.
3. Provide dental professionals with the latest information about the risks, benefits and costs of amalgam and all alternative restorative materials.
4. Encourage changes in dental restorative practices to maximize preservation of sound tooth structure and to optimize the appropriate use of amalgam and alternative materials in specific cases. In order to limit health care costs and mercury exposure, an educational program should also address the reasons for removal, replacement or repair of existing restorations.
5. Educate third party payers on relevant topics of conservation techniques and materials such as sealants and preventive resin and appropriateness of restoration repair in specific cases to assure reimbursement.

Recent concern over the safety of a main ingredient of dental amalgam, elemental mercury, stimulated a two-part comprehensive scientific assessment by the U.S. Public Health Service of the benefits and risks of amalgam. These assessments led the PHS Committee to Coordinate Environmental Health and Related Programs to charge its Subcommittee on Risk Management to develop a strategy for addressing increased public concern about the safety of dental amalgam. In turn, three integral work groups were formed to examine current research, regulatory controls and educational activities relating to dental amalgam and to propose new initiatives designed to better define, communicate and control dental amalgam risks.

The specific charge to the Education Work Group was to review and evaluate the Risks and Benefits assessments and consider whether new consumer and professional educational efforts are needed. The review of both documents by the Work Group was for informational purposes and not to evaluate the scientific accuracy of the documents. The Work Group sought to identify what pertinent information in the assessments should be conveyed to consumers and dental professionals.

Over the past decade, the use of amalgam has declined because of a decrease in dental caries and improvement in alternative materials. Nevertheless, the Benefits Assessment concluded that dental amalgam continues to play an important role in the dental restorative process. Amalgam's characteristics of durability, ease of use, and low cost contribute to its widespread use. Indeed, available substitutes can serve only in a limited number of specific situations for restoring posterior teeth.

Substantial health benefits can accrue to individuals and the population from the use of dental amalgam by preserving healthy tooth structure. The Benefits Assessment emphasized preservation of the maximal amount of healthy tooth structure. Through the use of conservative techniques and materials in situations where amalgam is. now often employed. These materials and techniques include dental sealants and preventive resin restoration (conservative composites), rather than amalgam.

The Benefits Assessment also recommended that dental practitioners emphasize preventive strategies including the use of fluoride, diet modification, oral antibacterial rinses, and personal and professional oral hygiene measures for preventing initial caries or reversing early lesions.

Finally, the Benefits assessment acknowledged a need for the professional curriculum, including undergraduate, graduate, and continuing dental education, to cover comprehensively the biocompatibility and indications for use of all dental restorative materials, as well as the importance of recording materials used in patient records and reporting known or suspected adverse reactions to dental restorative materials.

The Risk assessment addressed a number of potential public health concern issues regarding mercury in dental amalgam. The assessment noted that mercury is a toxic substance whose adverse health effects have been well characterized in high exposure occupational settings. Dental amalgam contains 40 to 50 percent mercury that is released in minute amounts over the lifetime of the restoration. Small amounts of mercury are absorbed and distributed throughout the body accumulating primarily in the brain and kidneys. However, the significance of this accumulation is unknown.

Studies have demonstrated that mercury levels in urine and various tissues are higher for people with amalgams than for controls who have no amalgams. However, there appears to be no scientific data indicating that these levels are associated with any adverse health effects. Mercury levels in the urine and tissues of dental personnel were found to be higher than in individuals with amalgams and those who are not occupationally exposed to mercury. These personnel have not been shown to suffer any adverse health effects.

There have been anecdotal reports of individuals recovering from various ailments after having their amalgams removed. However, no controlled clinical studies have shown adverse human health consequences associated with the placement or removal of amalgam. Nor have studies shown adverse health consequences for chronic low-dose exposure to mercury.

Although the Work Group did not conduct an exhaustive survey of current educational materials, it is aware of materials for both the professional and consumer. At the present time, Federal health agencies have developed few materials that could be considered as educational concerning this issue. Reports directed at informing the dental health professional are primarily in the form of scientific reviews and journal reported research. The most recent of these, Effects And Side Effects Of Dental Restorative Materials, is a report of an NIH Technology Assessment Conference that was held August 26-28, 1991. This conference brought together dentists, toxicologists and others to review the properties, effects and side effects of all dental restorative materials.

Additional materials include research articles related to dental materials published in professional journals by National Institute of Dental Research-sponsored investigators. There are also numerous booklets and pamphlets that do not deal directly with the mercury in amalgam issue but do cover related issues such as dental sealants and other dental restorative materials.

The private sector also has developed educational materials. The dental literature contains numerous articles directed at dental professionals about the use of dental amalgams. The Subcommittee on Risk Assessment noted many of these in its report. The American Dental Association (ADA) has prepared materials for use by professionals in patient education.

For the consumer, the ADA has developed a brochure entitled Dental Amalgam-Filling Dental Health Care Needs. The brochure uses a question and answer format to present some frequently asked questions about dental amalgam. The brochure has little information on safety. An impartial review article also appeared in the May 1991 issue of Consumer Reports.

The Work Group believes that the existence of these materials should not deter an independent educational initiative as proposed in this report.

The issue of communicating risk and benefit information to a patient or the general public is complex for many reasons. For example, conveying what science knows and doesn't know in an understandable manner presents a challenge because of the varying educational backgrounds of the audiences. Furthermore, some people may have inaccurate perceptions of risks and overreact. Some individuals are uncomfortable dealing with uncertainty and may respond emotionally to risk information. Their personal beliefs can be affected by the way the information is presented and by the credibility and authority of the source.

A major reason for initiating a consumer education program is to provide current and accurate information about the dental amalgam issue. The public's concern over the risk of dental amalgams was heightened following the 60 Minutes television broadcast on December 16, 1990. The report, based on anecdotal information and victim-oriented stories, heightened the perception of risk in many viewers. "If it happened to them, it can happen to me." Following the broadcast, Federal agencies and dental organizations received hundreds of calls and letters expressing safety concerns about amalgam. Providing accurate information would help people to better assess these reports.

Consumer anxiety and concern were further demonstrated in a 1991 survey of 1,083 adults (543 men, 540 women) sponsored by the American Dental Association. Forty-eight percent of those surveyed responded that they had heard about people possibly developing problems caused by amalgam restorations. Forty-eight percent also believed that people should have concerns about health problems that might develop from amalgam restorations. Finally, 16 percent had considered having their restorations removed while 4 percent reported having their restorations removed.

Current science seems to dictate that only those with a known or demonstrated allergy to a component in amalgam should have them removed. Studies indicate this to be less than 1 percent of the population. The fact that 20 percent are either considering or have had their fillings removed demonstrates a mix-match between scientific perception and public perception. This mix-match can have serious effects, since extensive removal of restorations poses potential oral and general health risks especially for the medically compromised. The removal of functional restorations will also have significant cost implications for individuals and public programs.

Americans have become better educated consumers and, in general, want to play a role in the decision making which affects them. Health agencies, professional and consumer organizations and others have developed and disseminated information on a wide range of health topics using a variety of media. Sometimes this information is used to supplement information given by the health care provider. Sometimes it is provided because of a concern that the information is not being conveyed by the health care provider. The information may be purely informational or the intent may be to modify behavior, that is, to motivate the person to take or not take a particular action. Whatever the reason, considerable precedent exists regarding government's role in this process. Informing the public about the risks, benefits, and alternatives to amalgams, as well as the risks and costs involved with removal of amalgam may help minimize conflict based on misunderstanding.

Conveying information to the dental and medical professional is less complex than conveying information to the public. Although health professionals are not immune to the shortcomings noted earlier for the general public, their training, education and experience help set up an environment more conducive to conveying information that contains uncertainties.

There are three main reasons for conveying the latest scientific information regarding amalgam use and safety to the health care community: (1) to inform them fully about the issue, (2) to encourage changes in dental restorative practices and (3) to provide accurate scientific information so providers can inform and educate their patients and engage them in the process of making appropriate clinical decisions affecting them.

The benefits and risks subcommittees have completed an exhaustive examination of the dental amalgam issue. Although most dentists and physicians are aware of the controversy over dental amalgam, it is likely that many do not have the in-depth information provided in the risks and benefits assessments. Providing this information might help foster candid discussions between patient and provider and focus on what's known instead of fears, rumors or anecdotal information.

Some dental professionals may not be fully informed about the benefits, costs and risks of alternative restorative materials since technology has changed so rapidly. Lack of current information could contribute to improper selection of restorative material resulting in:

1. Unnecessary destruction of healthy tooth structure if amalgam is used when more conservative techniques or materials may be indicated, or
2. Premature restoration breakdown and added expense and trauma for the patient when composite, ceramic, or glass ionomer alternatives are used in stress bearing situations where amalgam may be more appropriate.

Although there is no indication that amalgam is being over utilized, there are data to indicate that available preventive or conservative treatments such as dental sealants or preventive resin restorations are underutilized. Therefore, there may be a need to encourage changes in dental restorative practices. If providers are not well informed about these alternative restorative materials, they will be in a poor position to advise patients or make state-of-the-art decisions.

There are several risks involved with implementing either a consumer or professional education program on dental amalgam. Since the current risk information is inconclusive, a definitive statement regarding risk cannot be made. There are two opposing views on this issue. One group believes that dental amalgam is a toxic substance that should not be used as a restorative material. In addition, existing amalgam restorations should be removed. The other group believes that amalgam poses no adverse health risk. Such opposing views call into question the credibility of the messages, especially for the lay public. An educational message that highlighted these uncertainties would not be reassuring to that segment of the population which is not comfortable dealing with uncertainty.

Consumer anxiety also may increase as the issue gains more visibility. This might lead to actions that conflict with the intended purpose of the educational program. For example, some people might pressure their dentists to have old restorations replaced unnecessarily or have less effective restorative material used. This may result in more frequent replacement, increased cost to the consumer and ultimately an increased loss of healthy tooth structure.

Professional anxiety may also be increased. Dental professionals may feel that Federal health officials are undermining their authority being too prescriptive and dictating treatment. Public education could lead to increased demands on the dentist by the patient. In the litigious nature of our society these demands may generate increased concerns over liability for existing amalgam restorations and lead to unnecessary removals. Dentists may also choose to use an alternative material when amalgam would be preferred. In the long-term, this will engender increased costs, trauma and unnecessary tooth destruction. For those who are medically compromised this could also lead to morbidity and, in some cases, mortality.

Consumer and professional education are a cornerstone of good public health practice. By failing to act, the Public Health Service may lose considerable credibility if consumers feel that the government is silent on the risks. This could adversely affect future educational efforts.

Dental amalgam has received considerable media attention, and follow-up stories are likely. If educational efforts are not initiated, the lay press and television media may focus new attention on sensational anecdotal stories. Since consumers have already been sensitized, this new attention coupled with inaction by the Public Health Service would likely increase public alarm.

At the present time, we do not know the extent to which dental professionals are fully knowledgeable about the risks of dental amalgam or about the complete range of alternative restorative materials. Not informing them would place some dental professionals in a difficult position with respect to dealing adequately with a concerned patient. In addition, this is an opportunity to increase professional knowledge of conservative treatment therapies and the risks and benefits of alternative materials.

The Education Work Group reviewed the assessments developed by the CCEHRP subcommittees on risks and benefits. The Work Group reviewed both documents for content only and not scientific accuracy. On the basis of this review, factors relating to the need for consumer and professional educational programs were evaluated. The recommendation to proceed with educational initiatives is based on the following factors:

1. There is consumer uncertainty and anxiety. The public is being "educated" about this issue by the press and TV. These sources have sensationalized the problem. Health care agencies can facilitate development of a credible educational effort to curb further emotionalism and foster appropriate consumer and professional response.
2. Consumers are better informed today and desire to have an increased role in decisions affecting their health. In order for them to do this effectively, they need up to date, accurate, reliable information about the risks and benefits of dental amalgams and alternative restorative materials.
3. Although many health professionals are aware of the controversy, some may not be fully informed. As reported in a recent public survey, 16 percent of the respondents had considered having their amalgam restorations removed and another 4 percent had them removed because of concern over the potential health risks. It is not possible to assess whether these removals were done because the dentist or physician lacked information to appropriately counsel the patient, the dentist or physician recommended the action, or whether the patient requested the removal. However, there is limited scientific rationale to justify such a removal rate. Information in the benefits and risks documents should help all health care providers make decisions about dental amalgam removal and educate their patients about the known risks and the suitability of alternative restorative materials.
4. Currently available educational materials may be perceived as being biased by many consumers and health professionals. Informational materials have been developed by professional health organizations, schools and other interested groups. However, these materials may lack credibility with many consumers and health professionals because they were developed by groups with perceived self-interests.
5. Dental professionals may not be fully informed about the benefits, costs and risks of alternative restorative materials. To reduce possible over utilization of amalgam and under utilization of tooth-conserving techniques and materials as well as the over utilization and inappropriate use of alternative materials, there is a need for educational programs.
6. Action is expected. Federal health care agencies are expected to be responsive to public health concerns. If the ADA survey noted earlier is at all representative of feelings in the general public, then there certainly is a perceived public health concern, if not an actual one. The general public and the health care community must be informed properly about the risks and benefits of dental amalgams if attitudes and perceptions are to be changed. The Public Health Service is in the best position to present that information.

In addition, given the number of intergovernmental groups that have been evaluating dental amalgam restoration materials, many groups (consumer and professional) are expecting action on this issue. Credibility will be enhanced by a proactive program, but diminished over the long-term by a failure to respond now.

The Work Group determined that educational programs were necessary and advises the Subcommittee on Risk Management that there is a need to develop programs to:

1. Provide the public and health professionals with accurate information about the risks and benefits of dental amalgam. The Work Group believes this effort should commence with a press release from CCEHRP at the time this report is released allaying concerns and announcing that educational efforts will be forthcoming.
2. Inform the public and health professionals about safe and appropriate amalgam use and provide guidance to those considering removal of amalgam restorations and replacement with alternative materials.
3. Provide dental professionals with the latest information about the risks, benefits and costs of amalgam and all alternative restorative materials.
4. Encourage changes in dental restorative practices such that preservation of sound tooth structure is maximized and amalgam and alternative materials are used appropriately in specific cases. In order to limit health care costs and mercury exposure, the reasons for removal, replacement or repair of existing restorations should also be addressed.
5. Educate third party payers on relevant topics of conservation techniques and materials such as sealants and preventive resin and appropriateness of restoration repair in specific cases to assure reimbursement.

To minimize the risks associated with an educational initiative, the Work Group recommends that the following points be considered in developing and presenting the amalgam risks and benefits information:

• Involve consumers, manufacturers, and dental professionals in the development and dissemination of any educational program. The affected parties need to have ownership and believe that the final product represents full disclosure.
• The educational material must be clear. This is of special concern with respect to materials written for the lay public. However, steps should be taken to ensure that dental professionals fully understand the issue also. Development of typical patient questions and answers would be one method to assisting the dental professional in understanding and managing the problem. Case studies based on real situations would be another.
• Any information that is developed needs to deal forthrightly with the uncertainties. It would be just as harmful to downplay the uncertainties as it would to exaggerate them.

While some may argue that a definitive statement about the risks of dental amalgams cannot be made, the Work Group believes that a number of statements are possible. For example:

• Amalgam has been used for over 150 years with billions of restorations placed.
• There are no definitive studies indicating adverse health effects to humans from amalgam.
• Research continues to determine whether there are adverse health effects from low level exposures to mercury from dental amalgam.
• Federal agencies, like the Food and Drug Administration, will promote reporting of adverse reactions alleged to be associated with dental restorative materials and will continue to investigate them.
• There are effective alternative materials for many applications.
• Declining caries rates in the younger population and improved prevention techniques have generated a dramatic decline in the use of amalgam.

In addition, the public should be told that we are not certain about the long-term risks from alternative materials. It is possible that some small fraction of the population will demonstrate a reaction to one or more of these materials. In this context, the public should understand what "approval" of dental restorative materials by FDA signifies.

With respect to professional education, consideration should be given to summarizing information from the risks and benefits assessments into a special journal article as well as a technical report. In addition, an update on the issue could be developed for one of the health care related cable TV stations. Consideration should also be given to working with the American Association of Dental Schools, the American Association of Dental Examiners and the regional testing boards in developing a curriculum guideline addressing the use of amalgams and alternative restorative materials as well as developing test questions for national, regional, and State boards. Other suggestions include the development of restorative materials case studies for continuing professional education credits based on real clinical decision-making situations, producing displays and papers for local and national dental professional meetings and sponsoring workshops to train individuals to conduct educational seminars across the country (or sponsor seminars with those educators already expert in this field).

In discussions with the Regulatory Work Group, it was recommended that consideration be given to incorporating into any educational effort a component explaining FDA's role in regulating dental devices. In addition, they believed that dental professionals be made aware of procedures for reporting adverse reactions to FDA.

Finally, the Work Group recommends that consideration be given to the development of educational material for other health professional groups such as family physicians and pediatricians. Patients frequently consult with these specialists on issues regarding their health or the health of their children. There are anecdotal reports that some patients have had their amalgam restorations removed to ameliorate a medical problem based on the recommendation of their physician.

The Work Group recommends that the Food and Drug Administration, the National Institutes of Health and Centers for Disease Control be charged, separately or through an interagency group that exports finished products through it own networks, with developing both consumer and professional education programs. The Work Group believes that the manner in which the educational messages are presented is critical. The messages need to be positive, accurate and targeted. In the short term, this might increase anxiety, but in the long term such an approach will encourage appropriate and safe use of all dental restorative materials.

To enhance credibility of the educational messages, the Work Group recommends that educational materials be developed cooperatively with dental and medical professionals, manufacturers, consumer representatives and representatives from other government agencies.