Intraoral Ultrasound Probe for Dental Hard Tissue Imaging

描述(申请人提供)：牙齿骨折的检测和诊断是一个困难但非常常见的临床问题，已被美国牙髓协会基金会明确确定为首要研究重点。目前，牙科医生使用病史、目视检查、全面的牙髓检查和X线片来诊断隐裂牙。然而，临床体征和症状的变异性很大，往往不足以做出准确的诊断；与裂缝相关的体征和症状也与其他非常常见的诊断有关。虽然牙釉质中存在可见的折裂线和修复体与总自然冠体积的比例较高与牙齿断裂的发生率增加有关，但这一发现适用于患者群体，而不适用于个别患者的裂缝诊断。牙科X光片或锥形束计算机断层扫描通常不会显示细微的裂缝本身，直到发生一些分离，只有在细菌定植和炎症或感染之后才会显示随后的骨损伤。一种廉价、便携、非侵入性、非电离的识别裂缝的方法将具有重大的治疗价值。准确的诊断将允许选择适当的干预措施：无干预、监测、根管治疗和/或冠状覆盖或拔除。我们的方法是使用超声波作为一种非侵入性成像工具来检测牙齿骨折。超声在检测物理不连续方面非常有效，例如骨折或分离的修复体，即使这些不连续比声波波长更小。超声波还具有穿透大多数坚硬结构的能力，包括修复体--这是一项对放射学来说很困难的任务。因此，超声检查可以及早发现牙齿缺陷并制定治疗计划，避免治疗不足或过度或不适当，从而为患者带来显著的好处。超声波的另一个好处是它本身是非电离的，从而避免了与放射成像相关的健康风险。建议的新型探头设计将有效地将超声波能量直接耦合到牙齿中，并能够对牙齿内的表面和亚表面特征进行成像，包括骨折、龋齿和牙髓室的边界。这项建议将重点放在牙齿骨折上；然而，该探头将设计为对整个牙齿进行体积成像。这项第一阶段SBIR工作的重点是设计和集成一种用于牙齿骨折成像的定制超声波探头，并通过体外和体外研究证明技术可行性。

DESCRIPTION (provided by applicant): The detection and diagnosis of fractures in teeth is a difficult but very common clinical problem that has been specifically identified as a top research priority by the American Association of Endodontists Foundation. Currently, dentists use patient history, visual examination, comprehensive endodontic examination and radiography to diagnose cracked teeth. However, clinical signs and symptoms are highly variable and are often insufficient to reach a precise diagnosis; signs and symptoms associated with cracks are also associated with other very common diagnoses. Although presence of a visible fracture line in enamel and a high ratio of restoration to total natural crown volume are associated with an increased incidence of tooth fracture, this finding applies to a patient population, not to the diagnosis of cracks in individual patients. Dental radiographs or cone beam computed tomographs generally do not show hairline cracks themselves until some separation has occurred, only subsequent bony damage following bacterial colonization and inflammation or infection. An inexpensive, portable, non-invasive, non-ionizing method of identifying cracks would have significant therapeutic value. Accurate diagnosis would allow selection of appropriate interventions: none, monitoring, root canal treatment and/or coronal coverage, or extraction. Our approach is to use ultrasound as a non-invasive imaging tool for the detection of fractures in teeth. Ultrasound is highly effective in detecting physical discontinuities such as fractures or detached restorations, even if such discontinuities are smaller than the acoustic wavelength. Ultrasound also has the ability to penetrate most hard structures, including restorations - a task that is difficult for radiography. Therefore, ultrasonography may provide a significant benefit to patients by allowing early detection of tooth defects as well as treatment planning, avoiding under- or over- or inappropriate treatment. An additional benefit of ultrasound is that it is inherently non-ionizing, thereby avoiding the health risks associated with radiography. The proposed novel probe design will efficiently couple ultrasound energy directly into the tooth, and will be capable of imaging surface and sub-surface features within the tooth, including fractures, caries, and the boundaries of the pulp chamber. This proposal will focus on tooth fractures; however, the probe will be designed for volumetric imaging of the whole tooth. The focus of this Phase I SBIR effort is to design and integrate a customized ultrasound probe for imaging of tooth fractures, and to demonstrate technical feasibility through in vitro and ex vivo studies.