Dental Amalgam
and Alternative Direct Restorative Materials Dental Amalgam
and Alternative Direct Restorative Materials 
WHO Consultation on Dental Amalgam and its Alternatives
Geneva, 3-7 March 1997
List of Participants ........................................................................... i
Acknowledgements ......................................................................... iii
List of Contents ............................................................................. v
Executive Summary ........................................................................ vii
Consensus Statement on Dental Amalgam ..................................................... ix
Research Agenda .......................................................................... xiii
Risks and Benefits of Direct Restorative Materials as Alternatives to Amalgam, E. Reich ............. 1
Direct Restorative Dental Materials in Oral Health Care - Amalgam,
Composites and Glass lonomers, P. Kosella, J.S. Infirri, G.N. Pakhomov .......................... 17
Toxic and Allergenic Risks Due to Dental Biomaterials, M. Golberg and G. Zeilig ................. 35
Mercury Exposure from Dental Amalgam Fillings: Absorbed Dose and the
Potential for Adverse Health Effects, J.R. MackertJr. and A. Berglund ........................... 45
Dental Amalgam and Human Health, Current Situation - A New Zealand
Review, T.W. Cutress ....................................................................... 61
Evaluation of Toxic Effects of Resin Based Restorative Materials,
A. Schedle, J.E. Dahl, W. Parzefall, W. Aberer, A. Hensten-Pettersen............................. 73
Prevention and Policy of Avoiding Environmental Contamination of Mercury
from Oral Care, Including Amalgam Waste Management Issues, D.M. Meyer .................... 93
Occupational Health Problems Associated with Dental Materials, A. Henston-Pettersen ........... 99
Dental Amalgam. A Report With Reference to The Medical Devices
Directive 93/42/EEC from an Ad Hoc Working Group
Mandated by the European Commission, I.R. Cooper ......................................... 105
Reporting of Adverse Reactions to Dental Biomaterials Criteria and
Preliminary Results from the Norweigian Registry, N.R. Gjerdet ............................... 139
The Use and Safety of Dental Amalgam: An Overview of Research and a
Proposed Research Agenda, N.S. Braveman ................................................. 149
Summaries of Six Review Papers, T.W. Cutress, A. Berglund .................................. 171
The Use of Dental Amalgam in Sweden, A. Berglund ......................................... 183
Perceptions in the Selection of Dental Restorative Materials, E. Widstrom ....................... 195
Dental Amalgam: Utilization Trends, Alternative Therapies and National Policy,
D. Jacobson and C. Eccleston ............................................................... 205
Policy of the United Kingdom on the Use of Dental Amalgam, I.R. Cooper ...................... 217
Dental Amalgam and Human Health, Current Situation - A New Zealand Review,
T.W. Cutress ............................................................................. 223
Update of Amalgam use in Japan, M. Nakata ................................................ 237
Policy and Situation in Germany With Respect to Dental Amalgam, E. Reich .................... 233
The Use of Dental Amalgam in Africa, S.J. Thorpe ............................................ 239
National Policies on Amalgam Use in Eastern Mediterranean Region, S.A. Hussein .............. 243
This non-serial publication by the WHO Oral Health Programme is based on spedally prepared working papers and presentations made at the WHO Consultation on assessing the risks and benefits to health, oral care and the environment using dental amalgam and its alternatives. Some of the material was made available to the participants prior to the meeting, including detailed reviews of scientific literature related to dental amalgam and other direct restorative materials. Single reprints and abstracts of publications were also at hand and some were circulated prior to the meeting. All these documents formed the basis for detailed discussions which were initiated by reviewing the 1995 WHO/FDI Consensus Statement on Dental Amalgam. The names and addresses of the participants and their affiliations is attached in Annex 1.
In his opening statement Dr N.P. Napalkov, Assistant Director-General, on behalf of Dr Hiroshi Nakajima, Director-General of WHO, requested participants to review and update the WHO/FDI Consensus Statement on Dental Amalgam, to prepare a proposal for a research project on assessing the risks and benefits of dental amalgam use, and alternative restorative materials, and to identify the possibility of establishing a network between national and international groups and individuals for global monitoring of all issues related to me use of dental restorative materials. In fact the idea to organize this meeting was made in 1995 when WHO started to receive numerous requests from WHO Member States, organizations and individuals on various aspects related to the use of dental amalgam following the distribution of the WHO/FDI Consensus Statement on Dental Amalgam. The FDI World Dental Federation, which is a non-governmental organization in official relations with WHO, was invited to contribute. After approval by the FDI Council, a joint WHO/FDI Consensus Statement was then distributed in the form of a note verbale by the Director-General of WHO to all WHO Member States on 25 October 1995.
To provide more information to the Member States, WHO/ORHwas requested to review again the WHO/FDI Consensus Statement and if necessary draft a relevant document on dental amalgam use, taking into account the benefits, but also risks for individual, occupational, and environmental health of restorative materials. The project was thoroughly scrutinized by the WHO Programmes on Environmental Health and Occupational Health.
Being firmly convinced only the prevention of dental diseases can solve all the problems in relation to the use of restorative materials, it should be emphasized that the complete eradication of dental caries may not be possible in the foreseeable future. Consequently, the approaching problems should be addressed, not only in relation to dental amalgam, but also to composites, glass ionomers and mercury free alloys. Thus, the WHO Consultation was limited to direct restorative materials, that is, materials which are pliable and inserted into the tooth during the same visit as the caries is removed. Indirect restorations usually required two visits to the dental office. They comprise of inlays, onlays and crowns which are prepared from dental casting alloys, ceramics or rarely from resin based materials. These indirect restorations are from 5-8 times more expensive than amalgam restorations.
Referring to requests received from Member States and individuals, it is clear that even by updating the WHO Statement it will still be difficult to meet all of the needs, since there are many important public health issues related to restorative dental material use which require coordinated global activities, including laboratory and clinical research, effective exchange of information between countries, institutions and individuals. In this connection, participants of the meeting have defined me major need for further research and to establish a global project based on registries of side effects of dental restorative materials. Two such registries have already been initiated by the
Departments of Health and Social Welfare in Norway and Sweden. Other countries are urged to start similar projects and the WHO will coordinate their efforts on a global basis and produce reports as needed.
The participants of the meeting have agreed that the main outcomes of the Consultation should be published as a WHO/Oral Health Programme document. It is believed this material as presented in this publication could assist health authorities and the public to understand and reflect on the current situation of dental restorative materials. Another reason for the publication of this book is for effective and rapid exchange of information on the topics discussed at the meeting and to prevent misunderstandings or misinterpretations of the results from various research projects or actions undertaken and policies implemented by some Member States in respect of the use of dental materials.
Gennady Pakhomov and Ivar A. Mjor