Intraoral Ultrasound Probe for Dental Hard Tissue Imaging

描述（由申请人提供）：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，已被美国牙髓医师协会基金会特别确定为首要研究重点。目前，牙医使用患者病史、视觉检查、全面的牙髓检查和x线摄影来诊断牙裂。然而，临床体征和症状变化很大，往往不足以达到精确的诊断；与裂缝相关的体征和症状也与其他非常常见的诊断有关。虽然牙釉质中可见的断裂线和牙冠自然体积与修复体的高比率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，而不适用于单个患者的裂缝诊断。牙科x光片或锥形束计算机断层扫描通常在发生分离之前不会显示发际线裂缝本身，仅显示细菌定植和炎症或感染后的骨损伤。一种廉价、便携、非侵入性、非电离的裂缝识别方法将具有重要的治疗价值。准确的诊断将允许选择适当的干预措施：不干预、监测、根管治疗和/或冠状覆盖或拔牙。我们的方法是使用超声作为一种非侵入性的成像工具来检测牙齿的骨折。超声在检测物理不连续性（如骨折或脱落修复体）方面非常有效，即使这种不连续性小于声波波长。超声波也有穿透大多数坚硬结构的能力，包括修复——这是射线摄影难以完成的任务。因此，超声检查可以通过早期发现牙齿缺陷以及制定治疗计划，避免治疗不足或过度或不适当，为患者提供显著的益处。超声波的另一个好处是它本身是非电离的，因此避免了与放射照相相关的健康风险。提出的新型探针设计将有效地将超声能量直接耦合到牙齿中，并且能够成像牙齿内部的表面和次表面特征，包括骨折，龋齿和牙髓腔的边界。该提案将侧重于牙齿骨折；然而，探针将被设计用于整个牙齿的体积成像。第一阶段SBIR工作的重点是设计和集成用于牙齿骨折成像的定制超声探头，并通过体外和离体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.