Turner Innovations proposes to develop a 3D intra-oral x-ray imaging system for use in dental clinics. Current 2D radiographs are often ambiguous for caries detection, are not usually able to visualize fractures in a tooth, and because they are plane projections they can miss tooth curvature and other anomalies important to dental diagnosis and treatment. Cone-beam computed tomography (CBCT) is a 3D imaging technique gaining broad acceptance in the oral and maxillofacial community, but the radiation dose to the patient is significantly higher than with 2D radiographs. When imaging a single tooth anatomy it is not appropriate to use CBCT due to the high radiation dose. What is needed is a 3D imaging system for dentistry that has superior resolution to intra-oral radiography for caries detection and crack detection, with much lower radiation dose than CBCT for canal visualization and implants planning. In order to achieve clinical acceptance, the system should be automated for simple operation with minimal operator manipulation, and perform rapid 3D image reconstructions to minimize the required imaging time. Turner Innovations, with previous success in dental hand-held x-ray products, proposes this total solution through this SBIR Phase I and Phase II funding. The objective of Specific Aim 1 is to build an automated breadboard prototype that will allow the dental staff to collect 3D images with a simple technique comparable to that used for a single 2D radiograph. Specific Aim 2A is a characterization study that explores the image quality from the prototype as a function of number and angle of the 2D projections. Specific Aim 2B is a patient dose estimation at each of the collection conditions from Specific Aim 2A, and a subsequent analysis of the trade-offs between image quality and patient dose. In Phase II we will build a fully functional prototype 3D imaging system with improved motion automation and integrated source/detector control in a housing suitable for installation at a dental clinic. User software will be developed with a GPU implementation of reconstruction and visualization software. Characterization of the system will be performed, and the need for any fiducially reference points to compensate for patient motion will be evaluated. Significant potential image artifacts will be evaluated, i.e. from metal fillings, etc. We will devlop a clinical protocol for using automated 3D tomosynthesis in the dental practice. Turner Innovations has successfully brought several devices to successful commercialization including the NOMAD, a hand held x-ray device through their former company Aribex where PI, Dr. Clark Turner was founder and CEO. They are confident in their ability to bring this technology through the regulatory pathway and into successful commercialization.
Public Health Relevance Statement: Public Health Relevance: Turner Innovations proposes to develop a 3D intra-oral x-ray imaging system for use in dental diagnostics. This simple and easy to use system will allow dentists and dental technicians to improve caries (cavity) detection, crack detection, perform implant planning on single teeth, and improve imaging for root canal procedures. All of this will be done at much lower radiation dose to the patient than other 3D imaging techniques.
NIH Spending Category: Bioengineering; Dental/Oral and Craniofacial Disease; Diagnostic Radiology; Infectious Diseases
Project Terms: Achievement; Anatomy; arm; Automation; base; Clinical; clinical application; Clinical Protocols; Collection; commercialization; Communities; Computer software; Computers; cone-beam computed tomography; Dental; Dental caries; Dental Clinics; Dental General Practice; Dental Radiography; Dental Staff; Dental Technicians; Dentistry; Dentists; design; Detection; detector; Development; Devices; Diagnosis; Diagnostic; Diagnostic radiologic examination; Dose; Evaluation; experience; Fracture; Funding; Hand; Housing; Image; Imagery; imaging system; Implant; improved; innovation; Intervention; light (weight); Low Dose Radiation; maxillofacial; Mechanics; meetings; Metals; Morphologic artifacts; Motion; operation; Oral; Patients; Phase; Procedures; Protocols documentation; prototype; public health relevance; Publishing; Pulp Canals; Radiation; Reading; reconstruction; Regulatory Pathway; Resolution; Small Business Innovation Research Grant; Solutions; Source; success; System; Techniques; Technology; Three-Dimensional Image; Three-Dimensional Imaging; Time; tomography; Tooth structure; Translations; Tube; Variant; Visualization software; X-Ray Computed Tomography
