NIDCR Strategies to Advance Novel Therapies and Treatments for Dental Structures Think Tank Summary: Restoration

Date of Event: September 7, 2022, 1:00 p.m.–5:00 p.m. (EST)

Points of Contact

Background and Objectives

NIDCR convened a two-day virtual Think Tank with a diverse panel of experts representing multiple domain areas to discuss the most critical and challenging questions on Strategies to Advance Novel Therapies and Treatments for Dental Structures, both, representing areas of high priority investment for NIDCR. The Think Tank utilized an open discussion format on Key Themes in dental restoration and tooth structure remineralization. Human teeth have a complex structure with an inner core of highly vascular, soft, and delicate pulp surrounded by the highly mineralized enamel and dentin tissues. Emerging biomimetic approaches aim to repair affected dentition mimicking the characteristics of a natural tooth in terms of appearance, biomechanical, and functional competences. New emerging materials can enable regeneration through inductive properties, including structural materials, optimizing ceramics for 3D printing and other advanced fabrications. Learning from other fields such as regenerative medicine (e.g., bone grafts), natural materials, and clinical performance of existing approaches would improve development and clinical performance of next generation restorative materials.

Key Themes and Recommendations

What are major hurdles and strategic solutions to advancing access to and use of currently available composite restorative materials?

Challenges

• Lack of focus on long-term performance of bonding layers at the interface between the tooth and restorative composite material.
• Lack of consideration of the biological component of patient factors impacting performance of restorative composite materials.
• Limited clinical lifespan of resin composite restorations (<10 years). It is not uncommon for a dentist to replace a filling in two years. There is also limited availability of robust effectiveness data on clinical lifespan of dental restorative materials.
• Limited dental school training on the use of different types of restorative materials in real-world practice and operator impact on restoration longevity.

Opportunities

• Embrace digital dentistry technologies to facilitate decision making and oral care delivery, such as use of advanced detection and analytics, scanners, CAD-CAM, 3D printing, specialized materials and others, to enable less preparation time compared to putting the composite on the restoration.
• Promote technical and entrepreneurial training in dental programs and improve dentist perceptions about operator effects on early failure modes of dental restorations.
• Development of new dental restorative composite materials that can effectively and quickly integrate into clinical use while overcoming current limitations of restorative approaches.
• Bride gaps in availability of reliable clinical data on long-term performance of dental restorative composites materials, including addressing potential failure modes at the tooth-restoration interface to improve the predictiveness of preclinical development.

What are major hurdles and strategic solutions to accelerating the clinical translation of next-generation dental restorative materials?

Challenges

• Adoption of new technologies can be a challenge in dentistry. High cost of restorative materials and the limited availability of funds related to professional development can limit investments, risk taking, and progression of restorative material development.
• Academic researchers, dentists, and novice small business innovators often have limited understanding on how to navigate the regulatory process, achieve important technology transfer milestones, and lead an entrepreneurial venture to translate innovation to market.
• High-risk populations often experience high level of disparities in oral health care and access to care.
• Concerns about the range in quality in 3D printing. Most printers are not measuring to the level necessary. Better ways to improving fabrication workflows through data led strategies, especially with a high-throughput lab vs. in-clinic, or office setting, and enabling availability of better performing materials optimized for specific use cases.

Opportunities

• Promote NIDCR programs to develop novel dental restorative materials. Consider consortium type opportunities that geared toward restorative materials development and education in entrepreneurship at early stages in dental schools.
• Cultural changes are needed. Initial training and working across disciplines to spin off ideas and products needs to be and early focus. Increase the interaction between dental and engineering schools and technology transfer offices.
• Novel materials are necessary to achieving better adhesion at the tissue-material interface and lasting clinical longevity (>10 years). Adoption of relevant, fit for purpose, digital technologies are needed. Exploring the potential value of different materials (resin-based or different chemistries) from outside of polymer science might be beneficial.
• Many digital technologies are moving into supporting dental, oral, and craniofacial applications, such as diagnosis and treatment of cleft palate. Mining real world data from dental schools, practice-based research networks, and patient health records has potential to enhance data-driven discovery and build confidence in new technologies.

How can real-world-data and real-world-evidence be leveraged to optimize research and development of novel restorative materials?

Challenges

• Disconnect between short-term controlled studies and practical, clinical adoption driven by long-term real-world data.
• Stakeholders do not always value real-world data, lack of shared failure data, and discrepancies between what the real-world data says. For example, dental implant success compared with some of the more controlled studies that have been published and submitted to the FDA.
• Long-term data and accessible databases are needed for dentists to change behaviors and have confidence in new products. AI and other digital technologies may facilitate the integration, harmonization, accessibility, and integrity of electronic health and dental patient-level data.
• Clinical trials do not currently provide comprehensive evidence to support evidence-based dentistry, and long-term clinical trials are often lacking in the literature.

Opportunities

• NIDCR, Centers for Medicare and Medicaid (CMS), FDA, insurers and other key stakeholders can be critical drivers to the use of real-world data.
• Establish clinical data registries with quality data on restorative materials that account for possible biases to help guide new research. Controlled clinical trials are very different from the real-world setting and data obtained from private practices is different. The quality of data collection in restorative dentistry is low. Dental materials are not well detailed in current databases.
• Leverage big data and addressing current barriers with data silos, harmonization, standardization, and integrity.

What can we learn from other domains (e.g., regenerative medicine, natural materials, clinical performance of existing amalgam and composite restorations) to guide research and development that improves the clinical outcomes (safety and effectiveness) of novel dental restorative materials?

Challenges

• Biocompatibility studies are performed too late in development, incentives and more predictive approaches are needed for early-stage biocompatibility testing.
• Disconnect with investors, material development and manufacturing processes needs to be considered as a whole, within a systems approach.
• Need for integration of esthetics, function, effectiveness, and longevity of dental restorative materials.

Opportunities

• Understanding the biology of hard tissue formation has improved a great deal, there is incredible complexity of the systems that needs to be better understood to guide the development of biologically relevant materials.
• Realizing the value of 3D printing and other digital fabrication technologies needs more approaches optimized to restorative dentistry along with better performing materials to meet complex challenges in dentistry.
• Restoration durability is more important than strength, particularly at the bonding tooth-composite interface. Preclinical development must evaluate concerns with long term effects of acrylic degradation in the mouth and opportunities for designing new bonding mechanisms (non-covalent and covalent).
• Tooth on a chip or organ-on-a-chip ideas could drive collaborative alternative approaches to biocompatibility assessment by dental material developers.

Attendees

Jeanne Ambruster, B.A.
Chief Executive Officer
Avenues Company

Eric Anderson, Ph.D.
Chief Operating Officer
Mussel Polymers Inc.

Ana Bedran-Russo, D.D.S., Ph.D.
Professor and Chair - Department of General Dental Sciences
Marquette University

Smadar Ben-Tabou, Ph.D.
Professor, Department of Marine Biology
University of Haifa

Joseph DeSimone, Ph.D.
Sanjiv Sam Gambhir Professor of Translational Medicine and Chemical Engineering
Stanford University

Josephine Esquivel-Upshaw, D.M.D.
Professor, College of Dentistry
University of Florida

Bernhard Ganns, B.Sc., M.Sc., Ph.D.
Professor of Dentistry, Vice Dean, Research
University of Toronto School of Dentistry

Jason Griggs, Ph.D.
Professor, Associate Dean for Research
University of Mississippi Medical Center

Mike Hubbard, D.D.S., Ph.D.
Professor, Division of Medicine, Dentistry and Health Sciences
Royal Children's Hospital, Melbourne Medical School

Sharukh Khajotia, D.D.S., M.S., Ph.D.
Associate Dean for Research and Innovation, College of Dentistry
University of Oklahoma Health Sciences Center

Hyun (Michel) Koo, D.D.S., M.S., Ph.D.
Founding Director, Center for Innovation & Precision Dentistry
Professor, Department of Orthodontics
University of Pennsylvania Dental Medicine

Deirdre Lyons, Ph.D.
Assistant Professor, Marine Biology
Scripps Institution of Oceanography

Tatjana Maravic, Ph.D.
Assistant Professor, Department of Biomedical and Neuromotor Sciences
University of Bologna, Italy

Phil Messersmith, Ph.D.
Chair of Bioengineering, Professor, Departments of Bioengineering and Materials Science and Engineering
University of California, Berkeley

Carmem Pfeifer, D.D.S., Ph.D.
Professor of Restorative Dentistry, School of Dentistry
Oregon Health & Science University

Kevin Rosso, Ph.D.
Laboratory Fellow and Associate Director of the Physical Sciences Division for Geochemistry
Pacific Northwest National Labs

Paulette Spencer, D.D.S., M.S., Ph.D.
Director, Institute for Bioengineering Research
Ackers Distinguished Professor, Mechanical Engineering
University of Kansas

Yu Zhang, Ph.D.
Professor, Division of Restorative Dentistry, Preventive & Restorative Sciences
University of Pennsylvania Dental Medicine