Advancing Imaging, Device Production, and Clinical Capabilities in Digital Dentistry (R41/R42 Clinical Trial Not Allowed)

Purpose

Digital dentistry uses advanced materials and powerful manufacturing technologies aided by 3D imaging and processing software algorithms to produce dental devices and perform complex dental procedures. This Funding Opportunity Announcement (FOA) encourages innovation, optimization and customization of core technologies in digital dentistry that improve efficiency of oral healthcare delivery, effectiveness of clinical decision-making and outcomes of treatments associated with dental, oral and craniofacial (DOC) tissues. Among the areas of interest of this FOA, are development of digital imaging and image processing capabilities for dental radiology, and the integration of 3-dimensional additive manufacturing with imaging tools. This FOA also supports efforts to develop, integrate, adapt, optimize, and validate new and existing dental materials designed for additive manufacturing approaches in the repair, replacement and restoration of DOC tissues.

Background

New digital tools and technologies are revolutionizing dental and medical fields and making patient care easier, faster, safer, and more effective. They are modernizing the way dental devices, procedures, and products are enhancing the personalization and delivery of oral health care. Digital dentistry incorporates computer-controlled components such as: 3D cone beam computed tomography (CBCT) imaging, computer-aided-design/computer-assisted-manufacturing (CAD/CAM), and 3D printing into the clinical workflow.  All disciplines of dentistry, especially prosthodontics, restorative dentistry and orthodontics benefit from routine application of CAD/CAM for inlays, onlays, veneers, crowns, fixed partial dentures, implant abutments and full-mouth reconstruction. CAD/CAM meets three challenges in dentistry: 1) ensures adequate strength of the restoration, especially for posterior teeth; 2) creates restorations with a natural appearance; and 3) makes tooth restoration easier, faster, and more accurate than other technologies.

CAD/CAM systems are composed of three major parts: 1) data acquisition unit-intraoral scanner; 2) software for designing virtual restorations; and 3) computerized device for creating the restoration, either through subtractive (milling/grinding), or additive (3D printing) manufacturing. Both, subtractive and additive manufacturing approaches present advantages for specific clinical applications. The integration of 3D CBCT, CAD/CAM, and 3D printing with advances in biomaterials has led to major improvements in dental care and treatment delivery. Paired with CAD/CAM, 3D printing and advanced image processing functionality, CBCT can improve the success rate of interventions. Dentists can simultaneously plan the implant and restoration, produce a surgical guide, and then fabricate and place the permanent implant restoration, in some cases, all within an office and in a single patient visit with reduced risk of potential complications and improved treatment outcomes.

Gaps and Opportunities

This FOA addresses key technology gaps affecting the productivity and quality of care in dental practices. In certain cases, dental radiographs and computed tomography offer limited capacity to detect disease and accurately predict post-operative anatomy and physiology. Also, these tools are not always able to estimate mechanical force distribution through soft and hard oral tissues, dental biomaterials and their interfaces. Development and implementation of novel digital dentistry methods that integrate different imaging modalities (CBCT, MRI, ultrasound, optical) with advanced image processing algorithms and expert systems have the potential to overcome current technical limitations in assessing oral health, and reliable pre-surgical planning and surgical guidance.

To meet this challenge, this FOA is seeking to integrate advanced imaging, surgical expert systems, and computer-aided manufacturing capabilities into clinical workflow to drive patient-focused solutions. Moreover, 3D printing protocols and high-performance materials need to be optimized to complement existing capabilities to produce dental devices in a clinical setting. CAD/CAM milling uses ceramics to produce restorations while 3D printing primarily uses polymer resins, and more recently, non-precious metal alloys coated with ceramic to produce restorations.  3D printing has capabilities to be highly accurate, handle complex shapes and small dimensions not achievable through CAD/CAM.  Similar to CAD/CAM, 3D printing can also be integrated into a clinical workflow to complement existing clinical capabilities.  The advantages offered by 3D printing create significant opportunities for digital dentistry to achieve more flexible, convenient and precise patient-centered solutions that are timely, cost effective, and complementary to current approaches

Specific Objectives

This FOA invites applications that propose development and implementation of novel digital dentistry methods by integrating different imaging modalities (e.g., CBCT, MRI, ultrasound, optical) with advanced image processing algorithms and expert systems to assist in oral health assessment, pre-surgical planning and surgical guidance. Development of advanced image processing software, including artificial intelligence (AI) tools, for image detection, classification, interpretation and clinical decision making in dental radiology are highly encouraged. Performance of new imaging-based systems must be verified and validated according to sensitivity, specificity, and accuracy requirements in support of specific intended preclinical and clinical utilities.  

This FOA requires that the performance of proposed tools, materials, devices and strategies be verified and validated for human safety and effectiveness according to recognized industry standards. Product development plans may include performance testing involving preclinical studies, human testing for feasibility, usability evaluation, and use of human tissue samples or secondary analysis of imaging and metadata from existing clinical studies. A quality systems approach should be applied for product development and testing of performance requirements according to required technical characteristics and clinically relevant conditions. Research of new materials and device production techniques must account for biocompatibility, mechanical, structural, and usability criteria needed to ensure clinical performance.

Examples of research projects may include, but are not limited to the following:

• Validation of high-performance materials designed for 3D printing approaches that allow the production of dental devices in a clinical setting
• Development of smart and secure expert software systems for treatment planning that account for oral tissue biomechanics and dental material properties
• Development of dynamic surgical guidance systems for pre-surgical planning that incorporate real-time tracking capabilities with multimodal image fusion and surgical navigation
• Implementation of accurate dental image processing and AI software tools to detect disease, stratify risk and optimize patient-specific treatment
• Development of new technologies for generation of digital impressions that penetrate gingiva non-invasively without fluid effects
• Development and clinical implementation of multimodal diagnostic imaging and dedicated image processing tools for intra- and extra-oral applications

Projects that are not appropriate for this FOA include:

• Development of imaging reagents (e.g., probes, contrast agents) as a primary focus
• Biomarker discovery
• 3D printing applications that include use of biological materials (e.g., bioprinting using cells)

See Section VIII. Other Information for award authorities and regulations.