Advances in Dental Research

Ensuring the Global Availability of High-quality Dental Restorative Materials J. Ferracane, J. Fisher, J.L. Eiselé and C.H. Fox ADR 2013 25: 41 DOI: 10.1177/0022034513502208 The online version of this article can be found at:

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Ensuring the Global Availability of High-quality Dental Restorative Materials the possibility that key decision-makers will provide the needed support to achieve the research agenda agreed upon by this diverse group of stakeholders.

J. Ferracane1*, J. Fisher2, J.L. Eiselé3, and C.H. Fox4 1

Restorative Dentistry and Biomaterials and Biomechanics, Oregon Health & Science University, 611 W. Campus Drive, Portland, OR 97239, USA; 2Université Claude Bernard Lyon I, Faculté d’Odontologie, 11, Rue Guillaume Paradin, 69372 Lyon Cedex 08, France; 3FDI World Dental Federation, Avenue Louis Casai 84, Case Postale 3, CH-1216 Cointrin, Geneva, Switzerland; and 4International Association for Dental Research, 1619 Duke Street, Alexandria, VA 22314, USA; *corresponding author, [email protected] Adv Dent Res 25(1):41-45, 2013

This is information presented at the IADR Dental Materials Innovation Workshop, December 10-12, 2012, King’s College London, UK. Sponsored by the International Association for Dental Research, FDI World Dental Federation, World Health Organization, United Nations Environmental Programme, and King’s College London Dental Institute.

Abstract The Minamata Convention, a global legally binding instrument (treaty) on mercury, has been the catalyst for the emerging agenda on global dental materials research. If the current and future challenges of oral health maintenance and healing on a global scale are to be met, a logical and effective research agenda for the discovery and introduction of new, environmentally sustainable, dental materials must be developed through a coordinated effort involving materials scientists, dental clinicians, representatives of industry, members of regional and national regulatory bodies, and advocacy from research organizations. For universal impact, this agenda should be created with awareness of several important ongoing initiatives, such as the WHO non-communicable diseases action plan, the UN sustainable development agenda, and the IADR Global Oral Health In Inequalities Research Agenda (GOHIRA). A significant contributor to this cause is the FDI and its membership, who, through their Vision 2020 initiative, acknowledge their role and responsibility in globally preventing and managing dental disease and providing leadership to the profession in terms of information dissemination and affecting change. Dental researchers also have an obligation to advocate for appropriate funding to match the identified research needs, thus enhancing


he development of materials to meet the current and future challenges of oral health maintenance and healing on a global scale is a goal of primary interest to the dental profession. The usual difficulties involved in producing high-quality materials that are biocompatible, durable, and easy to use are further complicated by the need to distribute such materials throughout the world at low cost. Further, the materials must be environmentally sustainable and stable during transport and storage in diverse environments. While some current materials already struggle to meet these requirements, additional regulatory policy changes ensure that new materials will be needed to achieve the goals. Clearly, a unified and coordinated effort involving materials scientists and clinicians, representatives of industry, members of regional and national regulatory bodies, and advocacy from research organizations is required to respond adequately to this challenge by developing a logical and effective research agenda for new dental materials. The following are summaries addressing this issue, based on presentations at the IADR Dental Materials Innovation Workshop held in London, England, December 10-11, 2012.

United Nations (UN) and World Health Organization (WHO) Policy and Strategies The current global policy framework offers IADR and its partners a rare opportunity to create a broad and diverse multi-sectoral and multi-stakeholder alliance to deliver a socially, economically, and environmentally sustainable dental materials research agenda, one which seeks to quantify and contribute to health and development outcomes. This section will outline examples of how the current agendas of policy and strategies of the United Nations (UN) and the World Health Organization (WHO) will affect the dental materials research agenda of the IADR and will suggest the need for the dental research community to build bridges within the broader UN policy framework. As described earlier by Dr. David Piper, the Minamata Convention and other UN initiatives related to the oral health research agenda have been referenced in the outcomes document of the United Nations Conference on Sustainable Development

Key Words UN, WHO, environmental impact, social development, economic development, research, oral health.

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(Rio +20), ‘The Future We Want’ (No authors listed, 2012b). While the Rio +20 outcome document is high-level policy, it shares the same aspirations and thematic areas as the International Association of Dental Research (IADR) Global Oral Health In Inequalities Research Agenda (GOHIRA). Alignment and harmonization with the UN Sustainable Development policy agenda will facilitate GOHIRA’s call for ‘imaginative steps to get research findings into practice, policy and health systems’. It will also ensure consistency and coherence among global policy, the implementation of any future dental materials research agenda, and commercialization of dental devices, technologies, and materials. Such a sustainable development policy–based approach would have 2 principal benefits. First, it would create an enabling environment for dental research, where dental researchers could collaborate with other sectors and contribute to multisectoral goals. This would strengthen existing relationships as well as help establish new ones. At the same time, it would raise awareness of and promote communication on dental research across different sectors. Second, adopting the 3 dimensions of sustainable development–namely, inclusive, sustainable, and equitable economic growth, social development, and environmental protection to frame a global dental materials research agenda–will facilitate effective planning and management. This is essential given the urgency, complexity, and scope of the challenge to implement the provisions for dental amalgam described in the Minamata Convention. The Minamata Convention, a global legally binding instrument (treaty) on mercury, has been the catalyst for the emerging agenda on global dental materials research. It is also a significant policy document for disease prevention and health promotion that clearly links the dental materials research agenda to the WHO Global Action Plan for Non-communicable Diseases (NCDs) 2013–2020 (WHO, 2009a). It does so by calling for the phasing down of dental amalgam by “setting national objectives aiming at dental caries prevention and health promotion, thereby minimizing the need for dental restoration”. The Convention also identifies numerous provisions for the use of dental amalgam, including the specific provision for “promoting research and development of quality mercury-free materials for dental restoration”. However, it is important to recognize that the Convention is not a stand-alone entity. It is part of a multi-sectoral framework of UN policy, instruments, and programs.

Environmental Development: Preventing Disease through Healthy Environments The UN Conference on Sustainable Development highlighted the increasing importance that governments are placing on protecting the environment and the broader social determinants of health. WHO recognizes the enormous impact that the environment has on health, in terms of both climate change and the diverse range of environmental risk factors, including physical, chemical, and biological hazards. The sound management of chemicals is critical for sustainable development, health, and the environment. The Strategic Approach to Chemicals Management (SAICM) is a policy framework to promote chemical safety around the world. The 3rd

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International Conference on Chemicals Management (Kenya, 2012) identified nanomaterials and nanotechnologies as emerging global issues, along with endocrine disruptor chemicals. SAICM is developing a health sector strategy (No authors listed, 2012a) to ensure that scientific evidence forms the basis for action in the development of effective preventive measures. Hence SAICM will be an increasingly important forum for dental materials researchers, as they look either to improve current dental materials or to develop new ones.

Green Economy — Sustained, Inclusive, Equitable Economic Growth The environmental impact of dental devices, technologies, and materials must be viewed as integral to the design of a global dental materials research agenda. Project Optimize, a collaboration between the World Health Organization (WHO) and PATH (Program for Appropriate Technology in Health), is ensuring that delivery and waste management systems are as advanced and innovative as the products they support. This environmentally sound ‘life cycle’ approach to dental products and services is an economic imperative and will strengthen socially responsible behavior as well as sustainable growth and development. The International Organization for Standardization (ISO) provides a range of tools in its ISO 14,000 standard, which allows for a common and shared pathway toward environmental sustainability and responsibility.

Social Development: Toward Universal Health Coverage The policy basis for the preventive approach to caries management has been established through the 2011 FDI World Dental Federation General Assembly resolution “Classification of caries lesions of tooth surfaces and caries management systems” (Fisher et al., 2011). This triangular policy linkage paves the way for innovation in minimal intervention and remineralization techniques and technologies, in addition to research into current and future alternatives to dental amalgam (Ismail et al., 2013). The life-course approach as described in the WHO NCD Global Action Plan will facilitate the development of an integrated public health and person-centered approach, as well as strengthening initiatives aimed at early childhood development. One of the strategic objectives of the UN Partnership for Maternal, Newborn and Child Health is to promote accountability for resources and results. This highlights the convergence of many UN agency strategies with the WHO’s universal health coverage, which is ‘increasingly seen as being critical to delivering better health and as a unifying goal for health system development’. The UN Sustainable Development framework could help the oral health sector work in a more collaborative and coordinate manner to address social determinants and equity issues (Fisher et al., 2012). In summary, the Minamata Convention has direct implications for dental materials research, but re-framing our approach to contribute to the WHO non-communicable diseases action plan and the UN sustainable development agenda offers an opportunity to implement GOHIRA in a comprehensive and sustainable manner.

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Industry Supply Chain for Dental Materials Industry is a major contributor to the goal of maintaining oral health worldwide, and its role is complex. While evidence of contributions to sustainable materials development and distribution based on demand and overall oral health benefits is substantial, industrial partners operate under the model of increasing shareholder value within a social responsibility construct. Therefore, the practical coordination of research programs across private industry, research organizations, safety regulatory bodies, and worldwide health organizations is critical to a successful relationship. Industry representatives often find the challenge of producing complex materials for a more select market simpler than providing more routinely used materials to a more global market. Specific issues relating to these difficulties involve regulations governing the transport of certain materials, components, and equipment across continental or national borders. Also, the challenge of providing materials and, perhaps more importantly, appropriate packaging that ensures stability to those in need in environments of temperature extremes is highly complex.

The Role of National Dental Associations FDI World Dental Federation is the umbrella organization for 130 National Dental Associations (NDAs), representing over one million dentists. FDI is a unique body whose purpose is to share information among members, set up global policy agendas, and implement those at the regional and country levels. FDI seeks to be the worldwide, authoritative, and independent voice of the dental profession to promote optimal oral and general health, to support the member associations in enhancing the ability of their members to provide oral health care to the public, and to advance and promote the ethics, art, science, and practice of dentistry. Within the United Nations agencies, decisions are made by the member states. It is then crucial for FDI to be able to convey these decisions and messages to national deciders through the NDAs. FDI and its membership acknowledge that they have a singular role and responsibility in terms of caries management and leadership in any process of change. Together, they are working to reduce the burden of caries in the population worldwide. Their actions take place in the sphere of political advocacy, professional and public education, risk assessment, oral health assessment, evidence-based disease management, and programs for caries prevention, private practice, and public health (Fisher et al., 2011).

Advocating with National Dental Associations On issues like dental restorative materials, FDI is in a unique position to ensure the global availability of high-quality materials, taking into account the existing local specificities, needs, and legislations. During the negotiations of the Minamata Convention on a global, legally binding instrument on mercury, FDI and its members supported the WHO approach on phasedown of dental amalgam (WHO, 2009b) based on: (1) increased prevention and health promotion, (2) best management practices and environmentally sound life-cycle management, (3) research

on advanced restorative materials, and (4) education of current and future dentists. This was reaffirmed in a resolution approved in 2012 (FDI, 2013). The strategic approach was to provide all NDAs with the document: Use and Future Use of Materials for Dental Restoration. FDI Advocacy Toolkit (FDI, 2012), providing the necessary tools for dental professionals to develop supporting arguments when meeting with ministry representatives and to inform their own community. FDI will take a similar role on possible upcoming issues such as endocrine disruptors or nanoparticles, emphasizing the necessity for basic, translational, and clinical research for the development of high-quality dental restorative materials.

Demonstration Projects with National Partners Another opportunity for FDI is to set up collaborative projects with some of its members. FDI is partnering with the United Nations Environmental Programme (UNEP), WHO, and IDM (International Dental Manufacturers) in a pilot project on dental amalgam phasedown in East Africa. The NDAs from Kenya, Tanzania, and Uganda are leading the project at the national level. FDI is providing support through a “training the trainers” program, based, to a large extent, on material provided by other NDAs familiar with the topic. It is very much hands-on, involving the examination of patients, a demonstration of amalgam separators, and waste-handling. Nine amalgam separators will be generously provided by IDM for the pilot. The aim of this project is to give NDAs the necessary instruments to offer improved care to patients, information about prevention and restorative materials, and to raise the profile of oral health as a part of global health. The lessons learned from the pilot will be used to make information and educational materials available to all FDI members, so that, if necessary, this can be adapted and used for the education of the dental community.

A Vision for the Future of Oral Health Through the Vision 2020 initiative (Glick et al., 2012), the FDI membership has reaffirmed the Federation’s role as the global representative body of Dental Medicine and Oral Health. FDI goals for 2020 include 5 main elements: meeting the increased need for oral health care, expanding the role of health care professionals, shaping a responsive educational model, mitigating the impact of socio-economic dynamics, and fostering fundamental and translational research and technology. Vision 2020 will be the roadmap leading the actions of FDI and the NDAs. More than ever, in a global world, the role of FDI is to “lead the world to optimal oral health”. This includes setting up a proactive framework with the NDAs, such as Vision 2020, providing specific advocacy material on issues of importance for its members, and raising the profile of oral health in the research and clinical communities.

Research Advocacy Targeted at Government and Private-Industry Sources The availability of dental restorative materials operates in a complex milieu of technical feasibility, governmental regulatory

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approvals, professional understanding and incorporation into their practices, and patient acceptance. Ideally, a dental restorative material should meet all required clinical specifications, meet regulatory requirements, be easily incorporated into professional practice, and meet patient expectations. Should a material fall short in any of these areas, further research is needed. Another area of concern for the profession is the environmental life cycle of the dental restorative material, from sourcing, to manufacturing and processing, to clinical use, and to waste generated in the clinic environment, and even to waste generated from cremation. On behalf of our patients, the dental researcher has an obligation to advocate for appropriate funding to match research needs (Nurse and Fox, 2012). This usually means providing information and serving as a resource to elected representatives and their staffs at a national, state, and/or provincial level. Depending on the form of government, elected officials then allocate available funding to various agencies or ministries, such as the Ministry of Health, Ministry of Education, Ministry of Science, Department of Health and Human Services, etc. In non-elected forms of government, there are key government officials who can be approached regarding the need for biomedical research funding. In addition, there are private foundations, such as the Bill and Melinda Gates Foundation and Wellcome Trust, private industry, and academic institutions that provide funding for biomedical research. Once the right audience is identified, communicating the research needs in a direct, succinct, compelling, and effective manner is paramount. Stating the health and economic burden of oral diseases will be important to policy-makers. National databases can be mined for information like total dental expenditures from public and private sources or the percentage of national health expenditures going to dental care. While the macroeconomics of dental care delivery is important, it is also important to personalize the message by framing the argument in the form of a story. Relay the research needs using a patient or specific community that would have benefitted from a research advance. For approaching foundations, the research needs should be framed in relation to the foundation’s mission. The research advocacy message can be delivered in the offices of policy-makers or foundation staff, but often the most effective location to deliver the message is the site where the research is taking place or where the research needs can be most visibly demonstrated. Key decision-makers should be invited to research institutions or community clinics. The presence of elected officials should be promoted to local media, since positive press coverage will always be welcome. There is never a wrong time for research advocacy, but timing the advocacy message to when key decisions on funding are taking place will maximize the return. Researchers who take an active role in advocacy will then become a known and trusted resource for policy-makers’ future decisions. Given that other health research areas with higher disease burdens often dwarf dental research needs, it is important to work in coalition with other medical research advocacy organizations. Given the ever-unfolding associations between oral health and

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diseases and conditions such as diabetes, obesity and metabolic syndrome, atherosclerotic vascular disease, HIV-AIDS, HPV exposure, and oral cancer, we cannot operate in a dental silo. Since oral health is part of overall health, oral health care delivery should be integrated into the larger health system, and oral health research should be part of the biomedical research enterprise. Finally, it is not always about funding. There are governmental decisions made every day across multiple sectors that will have an impact on health. For instance, the purpose of this Dental Materials Innovation Workshop was to inform the decisionmaking of multiple governments in the UNEP intergovernmental negotiations on a mercury treaty to be called the Minamata Convention. In collaboration with the FDI World Dental Federation and many national dental associations, IADR has been supporting the WHO position that the continued availability of dental amalgam as one of many dental restorative materials is important for public health, and that any desired reduction in the use of dental amalgam must be coupled with an increased emphasis on prevention and health promotion, increased research into alternatives, and proper management of amalgam waste. This workshop focused specifically on the research needed on alternative dental restorations, including their biological effects, clinical outcomes, and environmental impact. Along with the UNEP Minamata Convention, the United Nations Non-communicable Disease Summit, the next World Health Organization Strategic Plan, and the formation of the European Research Council are recent international examples where oral health and oral health research advocacy messages were delivered. At the national level, there will be opportunities for advocacy as well. It is important to keep abreast of key government decisions on the horizon and be vigilant for health and oral health research implications. If we are successful in our advocacy efforts and build relationships with policy-makers, they may even come to us first.

Acknowledgment C.H. Fox serves as the Executive Director of the International Association for Dental Research. The authors received no financial support and declare no potential conflicts of interest with respect to the authorship and/or publication of this article.

References FDI (2012). Use and future use of materials for dental restoration. URL accessed on 6/25/2013 at: use_of_materials_english.pdf. FDI World Dental Federation (2013). FDI resolution on global legally binding instrument on mercury. Int Dent J 63:6. Fisher J, Glick M, FDI World Dental Federation Science Committee (2011). A new model for caries classification and management; The FDI World Dental Federation Caries Matrix. J Am Dent Assoc 143:546-551. Fisher J, Johnston S, Hewson N, van Dijk W, Reich E, Eiselé JL, et al. (2012). FDI Global Caries Initiative; implementing a paradigm shift in dental practice and the global policy context. Int Dent J 62:169-174. Glick M, Monteiro da Silva O, Seeberger GK, Xu T, Pucca G, Williams DM, et al. (2012). FDI Vision shaping the future of oral health. Int Dent J 62:278-291.

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Ismail A, Tellez M, Pitts NB, Ekstrand KR, Ricketts D, Longbottom C, et al. (2013). Caries management pathways preserve dental tissues and promote oral health. Community Dent Oral Epidemiol 41:e12-e40. No authors listed (2012a). Third session of the International Conference on Chemicals Management (ICCM3), Nairobi 17-21 September 2012. URL accessed on 6/25/2013 at: option=com_content&view=article&id=89:iccm-3-meeting-documents &catid=90:iccm-3&Itemid=527. No authors listed (2012b). Report of the United Nations Conference on Sustainable Development. URL accessed on 2/25/2013 at: http://www final%20revs.pdf. Nurse JT, Fox CH (2012). Funding for U.S. biomedical research: the case for the scientist-advocate. J Dent Res 91(Suppl 1):5S-7S. WHO (2009a). 2008-2013 Action plan for the global strategy for the prevention and control of noncommunicable diseases. URL accessed on 6/25/2013 at: WHO (2009b). Future use of materials for dental restoration. URL accessed on 6/25/2013 at: material_2011.pdf.

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Ensuring the global availability of high-quality dental restorative materials.

The Minamata Convention, a global legally binding instrument (treaty) on mercury, has been the catalyst for the emerging agenda on global dental mater...
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