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Effects and Side Effects of Dental Restorative Materials

National Institutes of Health,
Technology Assessment Conference Statement
August 26-28, 1991

Conference artwork depicting stylized teeth against a black background.

This statement is more than five years old and is provided solely for historical purposes. Due to the cumulative nature of medical research, new knowledge has inevitably accumulated in this subject area in the time since the statement was initially prepared. Thus some of the material is likely to be out of date, and at worst simply wrong. For reliable, current information on this and other health topics, we recommend consulting the National Institutes of Health's MedlinePlus http://www.nlm.nih.gov/medlineplus/.

This statement was originally published as: Effects and side effects of dental restorative materials. Technol Assess Conf Statement; 1991 Aug 26-28. Bethesda (MD): National Institutes of Health, Office of Medical Applications of Research; [1991]:(9):18.

For making bibliographic reference to the statement in the electronic form displayed here, it is recommended that the following format be used: Effects and side effects of dental restorative materials. NIH Technol Assess Statement Online 1991 Aug 26-28 [cited year month day]; (9):18.

Introduction

The incidence of tooth decay has been declining steadily among American children in recent years, but there remains a substantial demand in this country for dental restorative materials. More than 200 million restorations are placed each year.

The most commonly used dental restorative material is silver amalgam, followed by tooth-colored plastic composite materials, various cements, alloys, porcelain, and other ceramics. Selection of the most appropriate material depends on the extent of the cavity or defect in the tooth, the condition of the mouth, whether the restoration will be visible, and cost factors. The effectiveness of currently used materials in restoring tooth function is established, especially for amalgams, casting alloys, ceramics, composites, and glass ionomers.

Once placed, dental restorative materials are in prolonged contact with living tissues. Although they are made as strong and inert as possible, fillings may deteriorate or break, and minute amounts of component substances may be released into the mouth.

The possibility of adverse health effects from exposure to mercury from dental amalgam has kindled concern among some members of the public. The issue also has been debated in the scientific community. This conference was convened to evaluate and compare the data on the effectiveness and side effects of currently used dental restorative materials. It was sponsored by the National Institute of Dental Research (NIDR) and the National Institutes of Health's Office of Medical Applications of Research and held in Bethesda, Maryland, August 26-28, 1991.

Members of a scientific panel and a large audience heard and discussed a series of reports by experts on various aspects of this subject. The panel then weighed the scientific evidence and responded to the following five questions:

  1. What are the needs and benefits of tooth restorations?
  2. What are the incidence and severity of side effects associated with tooth restorative materials?
  3. Do materials for tooth restorations contribute to systemic disease and reactions?
  4. What are the benefit/risk ratios of different tooth restorative materials?
  5. What should be the future directions for research on materials for tooth restorations?

On the final day, the panel's statement was presented, and, after comment and discussion by the audience, it was amended and approved by the panel. Although economic, ethical, and other factors are unquestionably important in determining the selection and utilization of different dental restorative materials, they were not taken into account by this panel, whose charge was to focus on the scientific data related to the effects and side effects of these materials.

What Are the Needs and Benefits of Tooth Restorations?

From 1979-1990 there has been an increase in the number of dental office visits, yet U.S. dentists are spending less time on restorative care. U.S. dentists are spending more time in diagnosing and preventing disease than they did in the past. According to the American Dental Association (ADA), general practice dentists still spend more than 50 percent of their time on restorative care including fillings, crowns, and bridges. Of the restorative procedures, 60 to 70 percent are for replacement of restorative material no longer functional. Thus, restorative dentistry remains a major service of the average U.S. dental practice.

Conditions that create a need for restorative treatment are:

  • Caries.
  • Functional deficiencies.
  • Replacement of failed restorations.
  • Esthetics.
  • Abrasion.
  • Erosion.
  • Malocclusion.
  • Trauma.

The major benefits of restorative dentistry are to:

  • Correct defects caused by disease.
  • Relieve pain and discomfort.
  • Retain teeth.
  • Enhance speech and articulation. Enhance mastication and its effects on nutrition.
  • Improve facial esthetics.
  • Improve quality of life.

The NIDR recently reported that 50 percent of American schoolchildren ages 5 to 17 are caries free in the permanent teeth. However, this still leaves over 21 million children with carious lesions requiring restorative treatment. In addition, of the 17-year-old population group, at least 84 percent have at least one filling, indicating a future continued risk in this cohort.

Based on population projections of those over the age of 65, the number of teeth at risk for dental disease in 1980 was 2.8 billion and is expected to increase to 5 billion teeth at risk by 2020. This particular population group was born before the current caries decline and is expected to need dental restorative treatment for the next several decades. In fact, nearly 57 percent of the elderly have root caries and 21 percent of the 18 to 64 age population have root caries.

This increased incidence in root caries in the adult population will require the use of synthetic and other types of restorative materials in place of amalgam. There already has been a 38 percent reduction in the number of amalgam restorations in the United States since 1979. Similarly, a 50 percent decrease in the number of amalgam restorations has occurred in Denmark since 1977.

The decline in restorative treatment needs in the under 20 age group has been offset by the increased need in the adult population. Thus, at the present time, we have children, adults, and aged groups of the American population with continuing and substantial needs for restorative replacement of tooth structure.

The desirable properties of restorative materials include the material's behavior, application procedure, esthetics, and acceptance by the patient. A primary concern, related to the theme of this conference, is the biocompatibility of these materials. This attribute includes the questions of toxicity, allergy, and sensitivity. Also of importance is the long-term performance of the restoration, especially as related to future failure/ degradation and subsequent replacement. Important parameters include: strength, hardness, wear resistance, chemical resistance, and aesthetic appearance.

Dental restorative materials include many different types of metals, ceramics, and polymers, as well as combinations thereof. Many of these materials evolved over time while others have been "designed" (e.g., composites). These materials are suitable for many particular applications, although there are some applications that are less than optimal. Metals are used for amalgams, casting alloys, and porcelain fused to metal (PFM) restorations. Ceramics are used in conjunction with metals for PFM and also as "stand alone" material (such as computer-assisted design and computer-assisted manufacture applications). Ceramic materials are used as veneers, as components of luting agents, and as "protective" or "insulative" layers. Polymeric materials are used as cements and as cavity fillings (in conjunction with particulate ceramic filler materials). The benefits of these various materials have been demonstrated for particular restorative procedures and take advantage of the unique properties of each material. Specific examples are: strength and durability for metals, chemical durability and esthetic appearance for ceramics, and adhesion and esthetics for polymers. Most procedures utilize two or more different materials to provide a restorative system that is optimized for the correction of a specific condition.

Ease of use or placement is desirable for the practitioner. Here the need is for restorative materials and procedures that are not extremely sensitive to the operator's technique. For example, a restorative material that is insensitive to moisture would be easier to use and probably would have a higher success rate. Cements that bond well to dental tissues would improve the restorative process for both the dentist and the patient. The benefits of such materials and procedures would be less time and effort being required for the procedure and improved patient comfort. Some shortcomings of these materials are related to various characteristics such as mechanical performance and biocompatibility.

Some desirable goals for metals are improved esthetics and improved chemical durability. The complete elimination of "toxic" elements from all dental materials should be an everlasting goal. The current status is that virtually all metallic materials are suitable for use with minimal risk. Ceramics would benefit from improved strength and toughness, both of which seem to be realistic goals for the future. Polymeric materials with improved durability and reduced polymerization shrinkage would find immediate acceptance by the practicing dental community. There also should be an effort to reduce the amount of potentially toxic ingredients in all materials and their products of degradation.

What Are the Incidence and Severity of Side Effects Associated With Tooth Restorative Materials?

In considering the safety of tooth restorative materials, several factors must be evaluated. First, exposure potential is different among patients, dental workers, and industrial workers involved in the manufacture of the materials. Second, human factors such as age, sex, fetal exposure, allergic potential, diet, preexisting disease, and nutritional status should be considered. Third, exposure factors including quantity, route, length of exposure, accumulation in tissues, and excretion characteristics also must be weighed in determining the significance of currently available data.

Side effects from tooth restorative materials can be local or systemic, the result of direct injury, or the result of toxic or allergic reactions. Local side effects are due to inflammatory changes or are associated with hypersensitivity to specific materials. The incidence of allergic reactions appears to be small and idiosyncratic. Evidence from case studies has indicated that allergic reactions may occur with metals, including mercury, silver, copper, tin, nickel, chromium, and cobalt. Organic components of composites (e.g., methyl methacrylate) or their degradation products (e.g., formaldehyde) also can be sensitizing agents. Particulate substances may induce foreign body reactions such as silica granulomata.

There is little scientific evidence that tooth restorative materials induce systemic toxicity. Elemental mercury can be released from amalgams, and mercury has been found in the brain and kidney of humans and animals. However, except for dental personnel who have had excessive exposure due to repeated mishandling, altered brain or kidney function has not been correlated with dental amalgam exposure. Confirmed fetal effects from the use of dental amalgam have not been reported. The toxic potential of the other tooth restorative materials has been incompletely studied.

Although there is reasonably good evidence that mercury from dental amalgams contributes to the total body burden of this heavy metal, the relative contribution from dental amalgam has not been clearly determined. Large population studies of patients and dental personnel have not provided convincing data linking any specific disease to the body burden of mercury attributable to dental amalgam. On the other hand, there are numerous anecdotal reports of the association of a variety of neurologic, neuropsychiatric, and allergic diseases with the presence of dental amalgam, with palliation following removal being reported in some but not all cases. Even in such published reports, the severity of the symptoms has varied widely, and, in many cases, symptoms have been nonspecific. Further, the contribution of a placebo effect has not been evaluated. Based on reports in the literature, the incidence of adverse effects would appear to be extremely low. Interpretation of the literature is complicated by this relatively low incidence, and each individual case must be evaluated for other contributing factors such as age of the patient, the specific composition of the restorative material, other sources of environmental exposure to mercury, relative intake of mercury via food, and individual variations in tolerance. Thus, it seems from a review of the literature that the bulk of the present scientific evidence indicates that the degree of exposure to mercury via dental amalgam is insufficient to be considered a health risk in all individuals.

The evidence suggests that other restorative materials such as casting alloys, composites, glass ionomers, and ceramics can induce local reactions in some individuals. The incidence appears to be low based on the number of case reports in the literature and results from dental patient questionnaires. Systemic toxicity of these non-amalgam restorative materials also appears to be low.

The paucity of reports of systemic toxicity with the use of dental restorative materials could be due to a true "biological inertness" of the materials or could be due to other factors. For example, symptoms resulting from dental treatment might be reported to medical rather than dental personnel, with the correlation between dental restorative materials and systemic effects thereby being missed. The amount of potentially toxic residues released from restorations may be too low to cause a clinically detectable effect. In addition, clinical effects might develop over months or years rather than immediately after restoration or become manifest in tissues rendered more susceptible by other disease. Furthermore, most previous studies of restorative materials have involved subjective questionnaires rather than objective physiological and laboratory measurements. Tooth restorative materials generally have not been studied in properly designed longitudinal studies.

In summary, very few patients appear to be at risk of developing a local toxic or allergic reaction in response to the placement of restorations. Even when such reactions occur, they may not be clinically significant.

Do Materials for Tooth Restorations Contribute To Systemic Disease and Reactions?

Virtually all restorative materials contain constituents that, in excessive amounts and under certain circumstances, can contribute to systemic disease or adverse reactions. On the other hand, there is no clear evidence that these constituents in restorative materials are released in sufficient quantities and forms to produce toxic effects and hypersensitivity in humans. Although silver amalgam and the mercury it contains has received considerable attention, there is no substantiated evidence that its potential side effects in humans (i.e., neurotoxicity or immunologically mediated hypersensitivity) are more significant than those of alternative restorative materials containing substances such as tin, manganese, methyl methacrylate, chloroform, uranium oxide, and lithium. Data indicate that the level of exposure to these materials, particularly silver amalgam, has declined dramatically. The proportion of children and young adults with no restorations has increased over several decades, and perhaps as important, in those with restorations, the average number of restorations and their size has declined, further minimizing risk.

Allergy and hypersensitivity are immunologic reactions against foreign substances. They are classified as one of four types according to the standard Gell and Coombs classification. With regard to mercury in amalgams and other restorative metals, there is no evidence that Type I, II, or III reactions develop. If immunologic hypersensitivity to these metals does occur, it is likely to be a delayed hypersensitivity reaction (Type IV).

Mercury and other metals have been reported to produce local, immunologically mediated reactions in occupational settings. For a systemic delayed-type hypersensitivity reaction to mercury from amalgams to occur, there must be lymphocytes with specific reactivity to mercuric salts and sufficient absorption of mercury by ingestion or inhalation to produce a challenging antigenic load of mercuric salts. A hypersensitivity reaction to mercury from amalgam had been reported in about 50 cases since 1905. It is far from certain, however, that these cases were true immunologic reactions.

Systemic hypersensitivity reactions to mercury thus remain unproven. If they do exist, they are extremely rare, and the antigenic load responsible for these reactions could be from sources of mercury other than amalgams.

Inorganic mercury toxicity from occupational mishandling must not be confused with the purported effects from amalgam restorative treatment. Reports of neurological and psychiatric effects induced by dental amalgam are largely anecdotal. Estimating these effects of mercury from dental amalgam based on the current literature is difficult for the following reasons:

  • Reported "effects" on behavior have been obtained using subjective means that can be influenced by observer or patient bias.
  • The effects of inorganic mercury on the nervous system are nonspecific in that they can be induced by a wide range of mechanisms.
  • "Improvement" after removal of dental amalgam may be coincidental, especially when the total exposure has not been determined.
  • Not all sources of mercury and their exposure durations that contribute to the total body burden are identified routinely. Mercury exposure from dental amalgam must be put into perspective with total mercury intake from the diet, ambient air, water, cosmetics, and drug therapy.
  • Other factors can influence the dose of amalgam constituents available to interact with the central nervous system (CNS) (e.g., alcohol consumption, use of tobacco, bruxism, oral versus nasal breathing, gum chewing, iron-deficiency anemia and other dietary deficiencies, acatalasia, and drug therapies).
  • Susceptibility of the CNS can vary with critical periods of brain development. Experience with other agents damaging the nervous system (e.g., lead, radiation, alcohol, etc.) has demonstrated that we might expect a wide range of potential CNS dysfunction, depending on the stage of development at the time of exposure.

 

Mercury can be neurotoxic to dental personnel if it is repeatedly mishandled during trituration, placement, or removal of amalgams. The brain is considered the critical target organ. Chronic exposure to high levels of elemental mercury vapor (the form of mercury most likely encountered when handling dental restorative materials) can affect the nervous system, but the development of symptoms and significant exposure can be prevented when appropriate handling precautions are heeded.

The kidney also has been identified as a major organ for sharing the body burden of mercury. Studies of individuals with long-term low-level occupational exposure to mercury vapor have not demonstrated any significant renal function abnormalities. At present, no scientific evidence exists that mercury from dental amalgam contributes to renal disease in dental workers or their patients.

What Are the Benefit/risk Ratios of Different Tooth Restorative Materials?

Benefits include ease of placement of the material for both the patient and dental personnel involved, costs, longevity, ability to maintain and improve such functions as eating and speaking, freedom from pain, esthetics, and effect on tooth life expectancy. All these benefits should be assessed in light of their contribution to the dental, oral, and general health and well-being of the patient. The risks associated with these materials may be short- or long-term, localized or systemic, and may pertain to special population groups such as pregnant women, young children, dental personnel, or individuals with particular immunological predispositions.

Lack of reliable quantitative estimates of the risks and benefits of the various dental materials discussed at this conference precludes calculation of benefit/risk ratios. The paucity of scientific data concerning risks associated with restorative dental materials was apparent. As a result, benefits and risks can only be compared in qualitative rather than quantitative terms.

Different clinical conditions require restorative materials with particular qualities and characteristics, including malleability, strength, and esthetics. Although for some restorative needs, more than one material fulfills the requirements, for others, only one is appropriate. However, the benefits of single tooth restorative materials are similar when the materials are selected properly. Composites, glass ionomer cements, and ceramics provide excellent esthetics and, as technological developments progress, improved longevity. Amalgams, cast alloys, and ceramics, however, offer additional strength and durability.

All materials introduced into the oral cavity may present some risk to the general population. Individuals and groups may experience greater risks because of heredity or unusual clinical characteristics. Taking all the scientific evidence that is presently available, the benefits of existing dental restorative materials far exceed the currently documented risks at patient exposure levels to these materials.

What Should Be the Future Directions for Research On Materials for Tooth Restorations?

 

  1. Carry out long-term epidemiological and multidisciplinary studies to determine whether there is a link between restorative materials and the incidence of local and/or systemic effects and establish the benefit/risk ratios of these materials.
  2. Determine the long-term effects of dental restorative materials on the developing organism.
  3. Develop new methods and materials for restoring teeth such as utilizing bonding agents with improved composites, amalgams, and new biocompatible materials that minimize removal of healthy tooth structure, release cariostatic agents, and reduce the risk of side effects.
  4. Determine the composition, degradation, release pattern, and pharmacokinetics of all restorative materials and their components under a variety of conditions. The effects of such materials and their components on cells, tissues, and organs should be established.
  5. Investigate the cellular and molecular mechanisms by which mercury at different concentrations damages different types of cells and tissues, e.g., oral cavity, nervous system, kidney, etc.

Conclusions and Recommendations

Conclusions

Current dental restorative materials can be used effectively for restoring teeth for functional or esthetic reasons. Virtually all restorative materials have components with potential health risks. However, there is no scientific evidence that currently used restorative materials cause significant side effects. Available data do not justify discontinuing the use of any currently available dental restorative materials or recommending their replacement.

Although mercury vapor is released from dental amalgam, the quantities released are very small and do not cause verifiable adverse effects on human beings. While there is no scientific evidence that existing dental restorative materials are not safe, it must be recognized that the supporting data are incomplete.

Recommendations

 

  1. Manufacturers of all restorative materials should provide an insert or "stickers" listing the constituents used to formulate each material. This information should be referenced in each patient's chart.
  2. Dentists should install devices to recover waste amalgam residues in their offices for recycling to reduce environmental contamination.
  3. A specific Food and Drug Administration program should be established for reporting and investigating adverse reactions to dental restorative materials.

Technology Assessment Panel

William D. McHugh, D.D.S.
Conference and Panel Chairperson
Director
Eastman Dental Center
Associate Dean for Dental Affairs
University of Rochester
Rochester, New York
Alexia Antczak-Bouckoms, D.M.D., M.P.H., Sc.D.
Assistant Professor of Dental Public Health
Department of Health Policy and Management
Harvard School of Public Health
Boston, Massachusetts
Stephen A. Eklund, D.D.S., M.H.S.A., Dr.P.H.
Associate Professor of Dental Public Health
School of Public Health
University of Michigan
Ann Arbor, Michigan
Joseph L. Fleiss, Ph.D.
Professor and Head
Division of Biostatistics
Columbia University School of Public Health
New York, New York
Michael Kashgarian, M.D.
Professor of Pathology and Biology
Department of Pathology
Yale University School of Medicine
New Haven, Connecticut
Phyllis J. Mullenix, Ph.D.
Head
Department of Toxicology
Forsyth Research Institute
Boston, Massachusetts
Ray A. Muston, M.B.A., Ed.D.
Associate Professor
Planning, Policy and Leadership Studies
University of Iowa
Iowa City, Iowa
Frank G. Oppenheim, D.M.D., Ph.D.
Chairman and Professor
Department of Periodontology and Oral Biology
Boston University Goldman School of Graduate Dentistry
Boston, Massachusetts
Roy Patterson, M.D.
Chief
Division of Allergy and Immunology
Professor of Medicine
Northwestern University Medical School
Chicago, Illinois
Richard L. Pober, Sc.D.
Laboratory Manager
Ceramics Processing Research Laboratory
Massachusetts Institute of Technology
Cambridge, Massachusetts
Gary O. Rankin, Ph.D.
Professor and Chairman
Department of Pharmacology
Associate Dean for Biomedical Graduate Education and Research Development
Marshall University School of Medicine
Huntington, West Virginia
Jeanne C. Sinkford, D.D.S., Ph.D.
Professor and Dean Emeritus
Howard University College of Dentistry
Washington, D.C.
Anthony Paul Turel, Jr., M.D.
Director
Department of Neurology
Geisinger Medical Center
Danville, Pennsylvania
Robert Vickers, D.D.S., M.S.D.
Professor
Division of Oral Pathology
University of Minnesota School of Dentistry
Minneapolis, Minnesota

Speakers

Kenneth J. Anusavice, Ph.D., D.M.D.
"Biodegradability of Dental Ceramics"
Professor and Chairman
Department of Dental Biomaterials
College of Dentistry
University of Florida
Gainesville, Florida
Dorthe Arenholt-Bindslev, D.D.S., Ph.D.
"Dental Amalgam: Environmental Aspects"
Associate Professor
Department of Oral Medicine and Diagnosis
Royal Dental College
Aarhus C, Denmark
Stephen C. Bayne, M.S., Ph.D.
"Dental Composites/Glass Ionomers: Clinical Reports"
Section Head of Biomaterials
School of Dentistry
University of North Carolina
Chapel Hill, North Carolina
Rafael L. Bowen, D.D.S.
"Dental Composites/Glass Ionomers: The Materials"
Director
ADAHF Paffenbarger Research Center
National Institute of Standards and Technology
Gaithersburg, Maryland
Thomas W. Clarkson, M.D., Ph.D.
"Principles of Risk Assessment"
Professor and Director
Environmental Health Sciences Center
University of Rochester School of Medicine
Rochester, New York
Chester W. Douglass, D.M.D., Ph.D.
"Future Needs for Dental Restorative Materials"
Professor and Chairman
Department of Dental Care Administration
Harvard School of Dental Medicine
Boston, Massachusetts
Carl W. Fairhurst, Ph.D.
"Dental Ceramics: The State of the Science"
Regents' Professor
Medical College of Georgia
School of Dentistry
Augusta, Georgia
Palle Holmstrup, Dr.Odont., D.D.S., Ph.D.
"Oral Mucosa and Skin Reactions Related to Amalgam"
Professor of Periodontology
Department of Periodontology
Royal Dental College
Copenhagen N, Denmark
K. Sune Larsson, D.D.S., Ph.D.
"Teratological Aspects of Dental Amalgam"
Professor and Head
Department of Odontological Toxicology
Karolinska Institute
Huddinge, Sweden
Linda C. Lucas, Ph.D.
"Biodegradation of Restorative Metallic Systems"
Associate Professor of Biomedical Engineering
University of Alabama at Birmingham
Birmingham, Alabama
J. Rodway Mackert, Jr., D.M.D., Ph.D.
"Side Effects of Dental Ceramics"
Department of Restorative Dentistry
Medical College of Georgia
School of Dentistry
Augusta, Georgia
Miroslav Marek, Ph.D.
"Interactions Between Dental Amalgams and the Oral Environment"
Professor
School of Materials Engineering
Georgia Institute of Technology
Atlanta, Georgia
Sally J. Marshall, Ph.D.
"Dental Amalgam: The Materials"
Professor and Vice Chair for Research
Department of Restorative Dentistry
University of California at San Francisco
School of Dentistry
San Francisco, California
Ivar A. Mjo[umlaut]r, B.D.S., M.S.D., M.S., Dr.Odont.
"Problems and Benefits Associated with Restorative Materials: Side and Cost-Benefit Analysis"
Director
Nordisk Institutt for Odontologisk Materialpr�vning
Scandinavian Institute of Dental Materials
Haslum, Norway
Harold F. Morris, D.D.S., M.S.
"Casting Alloys: The Materials and 'the Clinical Effects'"
Director
Clinical Research Center for Restorative Materials
Veterans Medical Center
Ann Arbor, Michigan
Erik Christian Munksgaard, Dr.Odont., Ph.D.
"Toxic and Allergic Reactions Induced by Dental Restorative Materials"
Associate Professor
Department for Technology
Royal Dental College
Copenhagen, Denmark
Gudbrand �ilo, Dr.Odont.
"Biodegradation of Dental Composites/Glass Ionomer Cements"
Head
Physical/Chemical Division
Nordisk Institutt for Odontologisk Materialpr�vning
Scandinavian Institute of Dental Materials
Haslum, Norway
John W. Osborne, D.D.S., M.S.D.
"Dental Amalgam and Mercury Vapor Release"
Professor and Director of Clinical Research
University of Colorado
School of Dentistry
Denver, Colorado
Arne Hensten-Pettersen, Dr.Odont.
"Casting Alloys: Side Effects"
Senior Scientist
Nordisk Institutt for Odontologisk Materialpr�vning
Scandinavian Institute of Dental Materials
Haslum, Norway
John W. Reinhardt, D.D.S., M.S., M.P.H.
"Side Effects: Mercury Contributions to Body Burden from Dental Amalgam"
Harold R. Stanley, B.S., D.D.S., M.S.
"Dental Composites/Glass Ionomers--Side Effects: Local (Pulp and Soft Tissue) and Systemic Responses"
Professor Emeritus
Department of Oral Diagnostic Sciences
University of Florida
College of Dentistry
Ormond Beach, Florida
Michael F. Ziff, D.D.S.
"Documented Clinical Side Effects to Dental Amalgam"
Private Practice
Orlando, Florida

Planning Committee

Joyce A. Reese, D.D.S., M.P.H.
Planning Committee Chairperson
Health Scientist Administrator
National Institute of Dental Research
National Institutes of Health
Bethesda, Maryland
Rafael L. Bowen, D.D.S.
Director
ADAHF Paffenbarger Research Center
National Institute of Standards and Technology
Gaithersburg, Maryland
Elsa A. Bray
Program Analyst
Office of Medical Applications of Research
National Institutes of Health
Bethesda, Maryland
Mary Daum
Writer/Editor
National Institute of Dental Research
National Institutes of Health
Bethesda, Maryland
John H. Ferguson, M.D.
Director
Office of Medical Applications of Research
National Institutes of Health
Bethesda, Maryland
William H. Hall
Director of Communications
Office of Medical Applications of Research
National Institutes of Health
Bethesda, Maryland
Alice Horowitz
Coordinator
Health Promotion and Science Transfer
National Institute of Dental Research
National Institutes of Health
Bethesda, Maryland
Susan Johnson
Acting Chief
Office of Communications
National Institute of Dental Research
National Institutes of Health
Bethesda, Maryland
Miroslav Marek, Ph.D.
Professor and Associate Director
School of Materials Engineering
Georgia Institute of Technology
Atlanta, Georgia
Sally J. Marshall, Ph.D.
Professor and Vice Chair for Research
Department of Restorative Dentistry
University of California at San Francisco School of Dentistry
San Francisco, California
William D. McHugh, D.D.S.
Director
Eastman Dental Center
Associate Dean for Dental Affairs
University of Rochester
Rochester, New York
Ivar A. Mjo[umlaut]r, B.D.S., M.S.D., Dr.Odont.
Director
Nordisk Institutt for Odontologisk Materialpr�vning
Scandinavian Institute of Dental Materials
Haslum, Norway
Harold F. Morris, D.D.S., M.S.
Director
Clinical Research Center for Restorative Materials
Veterans Medical Center
Ann Arbor, Michigan
Gregory Singleton, D.D.S.
Chief Dental Officer
Center for Devices and Radiological Health
Food and Drug Administration
Rockville, Maryland
Dennis C. Smith, Ph.D., D.Sc., F.R.S.C.
Professor and Head
Department of Biomaterials
Director
Centre for Biomaterials
Faculty of Dentistry
University of Toronto
Toronto, Ontario Canada
Harold R. Stanley, B.S., D.D.S., M.S.
Professor Emeritus
Department of Oral Diagnostic Science
University of Florida College of Dentistry
Ormond Beach, Florida

Conference Sponsors

National Institute of Dental Research
Harald Lo�aut;e, D.D.S.
Director
NIH Office of Medical Applications of Research
John H. Ferguson, M.D.
Director

About the NIH Technology Assessment Program

NIH Technology Assessment Conferences and Workshops are convened to evaluate available scientific information related to a biomedical technology when topic selection criteria for a Consensus Development Conference are not met. The resultant NIH Technology Assessment Statements are intended to advance understanding of the technology or issue in question and to be useful to health professionals and the public.

Some Technology Assessment Conferences and Workshops adhere to the Consensus Development Conference format because the process is altogether appropriate for evaluating highly controversial, publicized, or politicized issues. Other Conferences and Workshops are organized around unique formats. In this format, NIH Technology Assessment Statements are prepared by a nonadvocate, nonfederal panel of experts, based on: (1) presentations by investigators working in areas relevant to the consensus questions typically during a 1-1/2-day public session; (2) questions and statements from conference attendees during open discussion periods that are part of the public session; and (3) closed deliberations by the panel during the remainder of the second day and morning of the third. This statement is an independent report of the panel and is not a policy statement of the NIH or the Federal Government.

Preparation and distribution of these reports are the responsibility of the Office of Medical Applications of Research, National Institutes of Health, Bldg 31, Room 1B03, Bethesda, MD 20892.

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