Priorities for Future Innovation, Research, and Advocacy in Dental Restorative Materials T. Watson1, C.H. Fox2, and E.D. Rekow3* 1

King’s College London Dental Institute, Department of Biomaterials, Biomimetics, and Biophotonics, Guy’s Tower, Guy’s Hospital, London SE1 9RT, England; 2International Association for Dental Research, 1619 Duke Street, Alexandria, VA 22314, USA; and 3King’s College London Dental Institute, Central Office, Guy’s Tower, Guy’s Hospital, London SE1 9RT, England; *corresponding author, [email protected] Adv Dent Res 25(1):46-48, 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 Innovations in materials science, both within and outside of dentistry, open opportunities for the development of exciting direct restorative materials. From rich dialog among experts from dental and non-dental academic institutions and industry, as well as those from policy, research funding, and professional organizations, we learned that capitalizing on these opportunities is multifactorial and far from straightforward. Beginning from the point when a restoration is needed, what materials, delivery systems, and skills are needed to best serve the most people throughout the world’s widely varied economic and infrastructure systems? New research is a critical element in progress. Effective advocacy can influence funding and drives change in practice and policy. Here we articulate both research and advocacy priorities, with the intention of focusing the energy and expertise of our best scientists on making a difference, bringing new innovations to improve oral health.

Background

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nnovation in materials science beyond the confines of dentistry has created new classes of materials, delivered ever-improving physical properties with meso-, nano-, and even smaller fillers, inspired new fabrication techniques, and many others. But what are these innovations, and how do we capitalize on them DOI: 10.1177/0022034513504437

to deliver future restorative materials? In December 2012, a workshop focusing on this question was co-sponsored by the International Association for Dental Research (IADR), the World Health Organization (WHO), United Nations Environmental Program (UNEP), the FDI World Dental Federation, and King’s College London Dental Institute. Because caries remains ubiquitous throughout the world, with significant disparities across subpopulations, the workshop participants focused on innovation for direct restorative materials for use in a variety of clinical settings. Rich discussion informed by experts from dental and non-dental academic institutions, industry, funding agencies, regulatory agencies, and professional organizations raised many provocative questions, elucidating priorities for research and advocacy.

Research Priorities Many restorative materials exist, but none has survived the test of history for as long as amalgam, and few are as forgiving of operator skill and patient-related influences as amalgam (Bayne et al., 2013). While dental amalgam has been proven safe and effective for human use, environmental concerns about mercury are clouding the future of amalgam as a material of choice (Petersen, 2008; Ferracane et al., 2013). As we consider alternatives, success is often characterized by clinical lifetime. That, in turn, depends upon complex interactions among the patient, the restorative material, and the clinician/ operator who places the restoration. Patient-related factors include patient demographics, oral health, tooth condition, and the perceived value of alternative treatment options (Bayne, 2007, 2012). The materials available are influenced by the state of the science, emerging innovations, properties, safety factors, regulatory constraints, economic considerations, environmental impact throughout the lifetime of the material (from production to removal from the environment), geographic location (not all materials are available in all markets throughout the world), and corporate priorities (Thompson et al., 2013; Ferracane et al., 2013; Rekow et al., 2013). The clinician/operator adds a further variable to this mix, bringing different education standards and levels of skill but also pressures from the health care system in which he or she operates, and biases based on information he or she chooses to use regarding the material (Schulte et al., 2011; Pitts et al., 2013). All of these are strongly influenced by the

Key Words biomedical research, dental restoration, private-public sector cooperation, dental economics, dental materials, advocacy.

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health and vigor of the research and advocacy environment (Ferracane et al., 2013). So the first priority is to decide what problem we are trying to address. If clinical performance is the priority, how long should the restoration last? From the literature, we know that lifetime differences between controlled clinical studies and practice-based studies differ, sometimes rather dramatically (Bayne, 2012), suggesting that survival is highly dependent on the operator. Furthermore, it has been suggested that changing dentists also shortens the time to restoration replacement (Bayne, 2007). Should simple material(s) be created that require only one operative placement stage vs. multiple materials with multiple steps like etch, line, seal, fill? Or should an over-engineered material be developed that can be exceptionally forgiving of operator skill? Innovations beyond the traditional borders of dentistry need to be explored and may offer interesting alternatives for the future (Thompson et al., 2013). But how long will it take to modify, test, and introduce these new materials – and what will it cost to do so? There remains, of course, the tricky question of how we can ensure that new materials can deliver the expected lifetimes. We need to establish laboratory tests that reliably predict clinical performance and lifetimes. While some tests of materials properties and failure modes correlate with short-term clinical performance, few take into account potential allergic reactions, the influence of oral fluid absorption, systemic toxicity, ‘emotional toxicity’, and operator variations and ‘errors’ (Bayne, 2012). An important question is, what is the trajectory of the lifetime of the tooth when the restorative material has been placed? When failures occur, what failure modes are acceptable, and is it possible to repair the restoration or must it be replaced? With replacement, must additional tooth structure be removed? Interestingly, failure modes for most materials are time-dependent; early failures are highly correlated with operator-related factors, whereas later failures depend more on materials properties (Bayne, 2012). What exactly do we expect the restorative material to deliver? Should it simply fill the tooth, as is the case with amalgam? Must it also seal the material-enamel/dentin interfaces, as is the case with composite materials? Or, should it heal the tooth, as is now possible with some existing materials, where bioactive and biomimetic properties encourage pulpal regeneration and reduce likely breakdown of the tooth-restoration interface (Bertassoni et al., 2011; Burwell et al., 2012; Thompson et al., 2013)? The application(s) to be considered are equally important in the design of new materials (Rekow et al., 2013). Choices for some areas of the world are more challenging than for others (Ferracane et al., 2013; Rekow et al., 2013). The existing infrastructure is hugely influential. Some communities cannot rely on the predictable availability of electricity, making light-curing and the need for refrigerated storage impractical. Economic conditions, combined with health care system constraints, may limit high-end cost options. Access to care, including highly trained professional care, is yet another consideration. Dental caries affects between 60% and 90% of schoolchildren and the majority of adults throughout the globe (Petersen, 2008), yet

some areas of the world are estimated to have only one dentist for over 1.2 million people (FDI, 2012). This raises the question of whether efforts at innovation should focus on the creation of a single material or a collection of materials for different applications/ economies/geographies. In parallel, consideration must be given to what else is needed to ‘make the material work’ (i.e., curing lights, CAD/CAM systems, etc.). Together, these questions determine four priorities for research: (1) Define the problem to be solved. (2) From the problem definition, establish a specification for new restorative materials. (3) Explore future options from outside of dentistry that can be applied or tailored to dentistry’s needs. (4) Establish laboratory tests that predict reliably clinical performance and lifetimes.

Advocacy Priorities Patient knowledge informing their choices, the availability of restorative materials, and clinical/operator education and knowledge base are influenced by advocacy (Ferracane et al., 2013). The IADR can and should play a strong advocacy role. Through untiring efforts, it has created excellent linkages and networks with the research community, funding agencies, private industry, government policy, and professional organizations. Advantages, limitations, and indications for the use of existing materials can be integrated into the IADR’s knowledge community, providing a resource for researchers, clinicians, the public, and policy-makers (Bayne et al., 2013; Ferracane et al., 2013; Pitts et al., 2013). In-depth understanding of materials and dental science is essential for the development and understanding of the performance of new materials, as well as for establishing laboratory tests that reliably predict clinical performance and lifetimes. Government funding levels to support materials research have fallen over the past decade. Equally disturbing is the reduction in scientists being trained to fill research positions in dental schools (and industry). Together, this has shifted innovation from university to industry settings. Unquestionably, industrybased research is important, but understandable intellectual property concerns have the potential to limit the free flow of information that might otherwise be possible. The IADR and its members can advocate rectifying these funding challenges (Nurse and Fox, 2012). Suppliers of restorative materials are influenced significantly by a host of constraints, including: regulatory approvals at multiple levels; environmental influences throughout the production of restoratives from raw materials; delivery to the clinician/ operator across international borders (with associated and intrinsic tax structures, storage requirements, and regulatory approvals); cost pressures ensuring that either financial or social value is delivered to the corporation; and a host of other issues (Rekow et al., 2013). As in the case of amalgam, professional organizations and governments are challenged with recommending appropriate methods of minimizing the impact of

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Watson et al.

restoration waste and removed restorations on the environment (Bayne et al., 2013; Ferracane et al., 2013). At present, there is little harmonization of standards across borders for these issues (Ferracane et al., 2013). Through its relationships with WHO, UNEP, FDI, ADA, and other professional organizations, the IADR leadership and its members can catalyze discussions, leading to actions to facilitate the introduction and flow of materials to caregivers throughout the world. To summarize, based on the workshop discussions, advocacy priorities are that we should: (1) capitalize on IADR’s Knowledge Community to provide a resource describing advantages and disadvantages of existing materials and make it publically available; (2) advocate for research and training funding for materials scientists, with emphasis on dental materials; (3) provide a venue for the exchange of ideas and the formulation of multi-disciplinary materials science groups to involve the best scientists to address the challenges of dental restorative materials; and (4) capitalize on relationships among WHO, UNEP, FDI, ADA, and other professional organizations to harmonize standards, testing, and acceptance of approaches/materials choices.

Acknowledgments 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.

Adv Dent Res 25(1) 2013

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Priorities for future innovation, research, and advocacy in dental restorative materials.

Innovations in materials science, both within and outside of dentistry, open opportunities for the development of exciting direct restorative material...
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