April 3, 1992

Research Work Group Leader:
Stanford Hamburger, D.D.S., M.P.H. Food and Drug Administration

Research Work Group Members:
Thomas Callahan, PhD. - Food and Drug Administration
Stephen Corbin, D.D.S., M.P.H. Centers for Disease Control and Prevention
Jeffery Gift, PhD. - Environmental Protection Agency
Peggy Hamilton - Food and Drug Administration
Annie Jarabek - Environmental Protection Agency
Mark McClanahan, Ph.D. - Centers for Disease Control and Prevention
Kevin Tonat, M.P.H. - National Institutes of Health

INTRODUCTION

A major concern facing the public health and professional communities, as well as the public, is the potential for adverse health effects associated with the use of dental amalgam/mercury restorative materials. This concern has led the Public Health Service (PHS) to develop comprehensive scientific reviews of the risks and benefits of dental amalgam use. Pursuant to these reviews, the Committee to Coordinate Environmental and Health Related Programs (CCEHRP), through its Risk Management Subcommittee (RMS), formed three work groups to develop reports addressing professional and public education, regulation, and research recommendations related to the use of dental amalgam and human health. This report by the Research Work Group (RWG) is in response to five charges that were provided by the RMS as follows:

1. Evaluate the research recommendations presented in the risks and benefits report.
2. Develop rating criteria for identifying and prioritizing research initiatives.
3. Address the viability of developing an intramural tracking mechanism to ensure that meritorious research projects are properly considered and funded within the PHS.
4. Advise whether the use of dental sealants and other preventive restorations can further reduce the incidence of caries and, thus, the need for amalgam restorations.
5. In consultation with the Regulation Work Group, examine the relevance and utility of adverse effects information collected from FDA's Medical Device Reporting System and Problem Reporting Programs (MDRs and PRP, respectively) for ongoing and future research initiatives, and explore means for exporting such data to government and private researchers.

The RWG conducted extensive discussions of the charges which resulted in general agreement that the philosophical approach would be based on the public health aspect(s) of scientific research with an emphasis on what research would best address two important public health policy questions:

"Should dental amalgam continue to be recommended for use?" and, if not,

"Should existing dental amalgam restorations be removed and replaced with another material?"

These policy questions cannot be addressed with confidence until we obtain answers to several fundamental questions relative to potential adverse effects of mercury on human health that include:

Similar to the issues of lead neurotoxicity, mechanistic research on mercury toxicity and the dynamics of its release from dental amalgams is crucial given the limitations of epidemiologic evidence. Issues such as measuring doseresponse at very low levels, bioavailability, relative persistence of the effects of early exposures, and the identification of critical periods of sensitivity will not be identified by epidemiologic studies alone. Such studies are generally imprecise in terms of dose and they are frequently confounded by the multitude of variables present in human populations.

It is important to recognize that the changing manner of dental practice has a continuing impact on how dental amalgam is used and how its "risks" and "benefits" are assessed. Average caries scores, especially for children and adolescents, continue to diminish. This reduction is largely attributable to the widespread use of fluorides, especially community water fluoridation. Dental amalgam remains the most commonly used dental restorative material, with nearly 50 percent of dental restorative procedures still involving the use of dental amalgams. However, its use is declining as caries scores decline and alternative materials are substituted. Effective preventive methods (e.g. sealants) and the utilization of new and improved materials and techniques now permit a wider spectrum of clinical choices.

Background

The members of the RWG reviewed and accepted the amalgam benefits and risks reports as expert reviews and used them as a starting point for identifying and characterizing research needs. Numerous research recommendations were included in the reports, some general and some specific.

Each RWG member was asked initially to review and evaluate these recommendations. Additionally, RWG members were asked to identify questions or items suggested in the text of those reports that were not specifically addressed in the recommendations sections. These, in addition to the NIH Technology Assessment Conference document entitled Dental Restorative Materials and the recent FDA Dental Panel Report, comprise a rather complete inventory on amalgam safety and benefit issues. Additionally, research recommendations from the WHO International Programme on Chemical Safety (IPSC) Environmental Health Criteria 118 Inorganic Mercury were also considered.

Findings

Based on recent literature reviews, we conclude that several critical parameters relating to mercury toxicity and human health are unresolved: the specific health effects of low level mercury exposure, if any; the relevant absorption, distribution, metabolism, and elimination; putative biological markers of exposure and effect; the medical consequences; and, the significance of blood, urine, or tissue levels of mercury. Observations from the source reports cited that support this conclusion include the following:

1. The putative human health effects of mercury are not well established or pathognomonic at low levels of exposure.
2. Reported exposure levels are not consistent and are widely divergent. There is probably no zero-level of human exposure to mercury.
3. Direct human data are inadequate and subject to confounding. Although, adverse human health effects from high mercury levels are documented from occupational exposure, these studies are not adequate for making decisions about risks from low-level exposure.
4. Experimental animal data are inadequate and/or not helpful (e.g. sheep and rodent data may not be relevant to humans) because principal exposure may not be due to the vapor components.
5. There are no consistently accepted criteria from which to assess the failure of a restoration.
6. The exact mechanism of action of neurotoxicity from mercury is not established.
7. No complete quantitative risk assessment, including risk chain has been presented.
8. The mercury exposure and related health effects that may accompany removal of dental amalgam restorations as compared to not removing existing amalgam restorations have not been clearly established.
9. Information supporting the safety of alternative materials may be no more sufficient than the information available on risks or benefits of exposure to dental amalgams.

Background

The RWG discussed extensively the merits of developing a numerically based ranking system for purposes of establishing research priorities relative to dental amalgam. It was recognized that even if such a system were to be developed, its validity, objectivity, and usefulness would remain to be determined. Similar issue-specific systems or a generic system have not yet been developed for ranking research needs and opportunities in other CCEHRP areas of concern to the Work Group's knowledge. Additionally, it was apparent, after review of the risks and benefits reports, that there are so many areas meriting additional scientific research, developing a special ranking instrmnent at this time may be superfluous.

As an alternative approach, members of the RWG independently reviewed the risks and benefits reports, along with the abstracts from the NIH Technology Assessment Conference, and the WHO IPSC report and developed lists of research questions and needs. The RWG then employed an iterative delphi type process to develop a list of the most fundamental and important areas for research that could practically be pursued in the immediate future. These are areas felt to be most critical to sound public health decision-making. Notwithstanding this approach, a more extensive list of issues meriting additional research attention, reflecting an integration of individual RWG member efforts, are identified in Attachment 1 of this report.

Findings

Two major areas of research questions were identified - questions that were principally methodological or those that were substantive relative to the effects and mechanisms of mercury actions on human health, whether from dental amalgam or other sources.

Additional methodological concerns include:

Recommendations

Very specific research questions/ studies/designs should be reviewed by experts in the topical subject areas. An extensive list of currently funded research projects is appended (Attachment 2) that reflects RWG consensus as bearing on many of the scientific questions at issue.

Background

The RWG adopted the position that existing intramural research projects, whether conducted by PHS researchers or through extramural grants, are meritorious by virtue of the review processes they must undergo before approval or award.

A first approximation of research projects relevant to dental toxicity, mercury amalgam, and alternative dental restorative materials conducted throughout the PHS was obtained by conducting several searches of the PHS CRISP database (Attachment 2).

In order to ensure that duplicative efforts would be minimized, the RWG consulted with the CCEHRP Subcommittee on Research Needs on its concurrent efforts to develop a research tracking system for specific areas of interest to CCEHRP.

Findings

An Intramural tracking mechanism to identify and monitor research projects funded within the PHS is a viable undertaking. Alternative mechanisms of obtaining relevant information, such as CRISP (Attachment 3), are available but do not currently address the full requirement of this charge.

Recommendations

The system should be clearly distinguished from a system to track recipients of dental amalgam or a postmarket surveillance system. This system would essentially be a registry of research projects supported and/or sponsored by PHS agencies. The administration of a system is of prime importance. Since it is to encompass all of the PHS and is to be a tool for the Assistant Secretary for Health (ASH), it should be administered by that office and could be delegated by the ASH to a lead agency or committee. In order to be comprehensive, the system should include information from sister agencies (i.e., EPA, DOD) and the private sector.

A proposed intramural tracking system should incorporate, at a minimum the following information for each project:

1. Funding agency
2. Program title
3. Description of project
4. Purpose of this project
5. When results are expected
6. Linkages between anticipated outcome measures and actual findings
7. Milestones
8. Anticipated accomplishments
9. Categories: Basic sciences; Toxicology; Epidemiology; Clinical practice; Public health risk management (science. clinical)

All agencies would need access to the system in order to be able to identify areas of current and needed research and to decide how they would like to prioritize or solicit grant applications or project requests. Cooperation from participating agencies will be vital in order to establish a system that will be a viable tool for agency manages.

Background

Dental amalgam restorations have long been the mainstay of dental restorative practice. In fact, in previous decades when dental caries scores were much higher than today, it was not uncommon for many individuals to have dental amalgam restorations in virtually all their posterior teeth. Declining caries scores are a result of widespread preventive efforts, largely fluorides in drinking water and dental products. Dental sealants, which have been available for two decades, have only recently come into increasing prominence. In l989, approximately 13% of 8-year olds and 17% of 14-year olds had received dental sealants. The PHS, through the Healthy People 2000 initiative, has established the goal that by the Year 2000, 50% of children will have received dental sealants.

Sealants prevent caries by acting as barriers. Sealants fill surface pits and fissures that are prone to the development of caries. Caries protection may be determined by the sealants' ability to remain adhered to the tooth. As long as the sealant remains intact, caries will not develop beneath it. However, even where sealants have been partially lost, some protection may be gained from residual sealant occluding the depth of the pit or fissure. Still, the longevity of a sealant on a tooth is a prime determinant of success. Sealants are underused in both private and public health care delivery systems. Expanding the use of sealants would reduce the occurrence of dental caries in the population, and particularly among children.

Findings

The report on the benefits of dental amalgam has concluded, based on extensive scientific evidence, that dental sealants are extremely effective in preventing decay in the pits and fissures that are common to the chewing surfaces of the posterior teeth This is important since fluoride is only partially effective in preventing caries on these surfaces.

Historically, the near universal choice for dental restorative material in the majority of restoration situations for posterior teeth has been amalgam. However, newer materials and techniques, most notably the preventive resin restoration, and improved composite materials are modifying the "standard" choice in defined situations. With an ever strengthening commitment to preserving as much sound tooth structure as possible, dentists are increasingly relying on non-amalgam restorative materials where the physical stress requirements of a particular restorative situation permit. Plastic filling materials can be used by themselves or in combination with sealants where the extent of caries is conservative. Acid etching techniques that enhance retention of the restorations are substituted for the creation of undercut areas in the tooth preparation to prevent dislodgement. This results in the removal of less sound tooth structure.

Another alternative to dental amalgam in defined restorative situations are the glass ionomers. Since these materials do not resist stress well, they cannot be used in areas of heavy occlusal contact. They offer an added advantage of containing fluoride that can leach out and provide a supplemental caries preventive effect. Glass ionomers, like resins, are tooth colored and thus superior to dental amalgam from an esthetics standpoint.

Still, it must be remembered that the majority of posterior restorative situations do not permit the use of plastic fillings or glass ionomers. This is particularly true of replacement restorations that may need to be large or that restore areas of heavy occlusal contact. With caries scores declining in children and with individual carious lesions being generally less extensive than in the past, there is likely to be increasing substitution of these alternative materials for dental amalgam in the future.

Recommendations

Expanding the use of dental sealants and alternative materials to dental amalgam, where appropriate, should be promoted to the public and the dental profession.

Historically, little use has been made of the reporting system for dentally-related concerns. Thus, it has been of little utility for research purposes.

Findings

The relevance and utility of adverse effects information collected from the Food and Drug Administrations's MDRs and PRP for ongoing and future research is limited. A plethora of reports have been filed with chief complaints that were claimed to be resolved with the removal of amalgam/mercury restorations.

These reports, on relatively few subjects, may reflect a "selection bias". Approximately 550 reports have been entered into the system. The patients were self-selected and not representative of the general population. Representativeness is a basic requirement underlying statistical analysis. Preliminary frequencies relative to age, geographical distribution, and symptoms can only be considered as counts. The lack of population based data for comparisons severely limits any useful determinations. Reporting on these systems is not intended to provide precise quantifications of actual population-based risks. The MDRs and PRP are most useful for preliminary assessments of whether more formal surveillance or specialized studies are merited.

Recommendations

Only aggregate data are available from the MDRs and PRP reporting systems. Because of the limitations cited above, their value to researchers or others is severely restricted. Therefore, efforts to make the data more widely available are not likely to be useful.

SUMMARY

Based on comprehensive scientific reviews of the risks and benefits of dental amalgam, the RWG has identified an extensive list of research opportunities and needs relative to the safety and utility of dental amalgam and alternative dental restorative materials. Additionally, a smaller list of high priority research areas has been drawn from the comprehensive list, based on the potential to provide a sound basis for public health decision making about the continued use of dental amalgam.

There are enough areas of fundamental research merited, both in terms of low level mercury effects on human health in general and mercury vapor from dental amalgam in particular, that definitive answers will require research efforts over a period of many years. The available research evidence is not specific enough or strong enough to make sound pronouncements about human health risks from dental amalgam. Given the potential that end effects from low levy mercury exposure may well be subtle and non-specific and that the relative importance of various forms and sources of mercury are not clearly established, much work remains.

At the same time, it is encouraging that a wide range of research is already being conducted that should help to answer questions of potential mercury toxicity, as well as the safety and utility of alternative dental restorative materiels. A tracking system has been proposed that will permit the ongoing assessment of research efforts that bear on these questions. Agencies that carry out or sponsor research related to these questions could utilize the tracking system to assess how their resources could best be applied to addressing the most important scientific questions for rnaking sound public policy decisions.

Unlike many areas of potential health risk where extensive research remains to be conducted, a marked decline in exposure to the potential risk agent is already taking place as a result of declining caries rates, improved dental materials and treatment methods, and preference of the public for tooth colored rather than metal colored restorations.

1378 Computer Retrieval of Information on Scientific Projects (CRISP)

U. S. National Institutes of Health
Division of Research Grants
Research Documentation Section
Westwood Building, Room 148
5333 Westbard Avenue
Bethesda, Maryland 20892

Basic Information

Provides descriptions and indexing of biomedical research project supported by U.S. Public Health Service grants, cooperative agreements, and career award and research contracts, as well as intramural projects conducted by the National Institutes of Health; the Alcohol, Drug Abuse, and Mental Health Administration; the Centers for Disease Control and Prevention; the Food and Drug Administration; and others. Types of Database: Bibliographic. Language of Database: English. Timespan Covered: 1972 to the present. File Size: 625,000 records.

Subject Coverage

Research in biomedical and allied health fields. Input Sources: Applications, progress reports, research contract documents; annual reports, project narratives, and other government documents.

Data Elements

Typical Records Items: Project identification number, title; investigator, address; institution; sponsoring agency; primary terms; project abstract (if furnished)

User Aids

CRISP Thesaurus (annual) - contains more than 10,000 subject headings; available for purchase from the U.S. National Technical Information Service, 5285 Port Royal Rd., Springfield, VA 22161.

Database Availability

Online: BRS Information Technologics. File Label: CRISP. Covers 1986 to the present. Rates/Conditions:

$40 per connect hour (Open Access Plan); discounts available through the Advance Purchase Plan; 15 cents per full record displayed online; 20 cents per full record printed offline. As part of Federal Research in Progress and TOXLINE: each. database is described In a separate entry. Batch Access: Producer offers search services.

Print/lMicroform Products

Publications: Biomedical Index to PHS Supported Research (annual). Intramural Research Index to NIH, NIMH and NIAA Projects (annual).

Contact

February 1992

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

Education Work Group Members:

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

Executive Summary

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.

Background

Recent concern over the safety of a main ingredient of dental amalgam, elemental mercury, stimulated a two-part comprehensive scientific assessment by the US 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.

Rationale for Consumer Education

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 four 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.

Rationale for Professional Education

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 heatlh 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.

Consequences of Implementing Consumer and Professional Education Programs.

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.

Consequences of NOT Implementing Consumer and Professional Education Programs.

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.

Recommendations

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

Implementation Strategies - Consequences of Implementing Consumer and Professional Education Programs.

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:

Consequences of NOT Implementing Consumer and Professional Education Programs.

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:

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.

Professional Education Guidelines

Wlth 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.

Institutional Responsibility for Educational Program

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.