Periodontal Ultrasound/Photoacoustic Imaging (PUPI)

牙周超声/光声成像 (PUPI)

• 批准号: 10323593
• 负责人: ALI HARIRI
• 金额: $ 28.15万
• 依托单位: STYLOSONIC LLC
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-09-01 至 2022-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10323593
• 关键词: Acoustics; Address; Aftercare; American; Anatomy; Architecture; Area; Artificial Intelligence; COVID-19; California; Cardiovascular system; Clinical; Clinical Research; Collaborations; Consumption; Data; Dentistry; Dentists; Devices; Diagnosis; Diagnostic radiologic examination; Early Diagnosis; Engineering; Ensure; Evaluation; Eye; Fiber Optics; Food; Gingiva; Gingivitis; Goals; Health; Healthcare; Image; Imaging Device; Imaging Techniques; Incisor; Inflammation; Inflammatory; Ink; Lasers; Light; Lighting; Link; Location; Long-Term Effects; Manikins; Manuals; Measurement; Measures; Medical; Methods; Monitor; Morphologic artifacts; Optics; Oral; Oral cavity; Oral health; Outcome; Pain; Patients; Penetration; Performance; Periodontal Pocket; Periodontitis; Phase; Physiologic pulse; Plant Roots; Problem Solving; Process; Quality of life; Reporting; Resolution; Risk; Scanning; Signal Transduction; Squid; System; Technology; Telemedicine; Testing; Time; Tissue imaging; Tissues; Tooth Cervix; Tooth structure; Toothache; Transducers; Ultrasonography; Universities; Validation; Variant; Visual; Work; accurate diagnosis; accurate diagnostics; acoustic imaging; base; bone; cloud based; cytokine; data acquisition; design; human subject; imaging modality; imaging system; innovation; instrumentation; miniaturize; oral care; photoacoustic imaging; prototype; recruit; sensor; soft tissue; tool; touchscreen; treatment response; underserved community

PROJECT SUMMARY The objective of this proposal is to design and validate a Periodontal Ultrasound/Photoacoustic Imaging (PUPI) device which can non-invasively measure periodontal pocket depth, clinical attachment loss based on cementoenamel junction (CEJ) location, gingival biotype and inflammation. Current periodontal evaluation methods are inaccurate because they are based on visual inspection and periodontal probing. While radiography offers detailed information about hard tissues such as bone and teeth, more detailed information about soft tissue is usually missed in radiography. Ultrasound/photoacoustic approach has been used in soft tissue imaging but rarely in dentistry because they have a large size transducer which limits the entire oral cavity scan. This is a fundamental limitation of existing technology. To solve this problem, StyloSonic LLC will construct and validate a miniaturized handpiece with a compact laser diode for ultrasound/photoacoustic imaging to provide key periodontal metrics. PUPI offers real-time, accurate, and repeatable measurements with utility in diagnosis and therapy monitoring. That is the value of this proposal. The workflow will include two parts: Aim 1 will design and fabricate the PUPI prototype and Aim 2 will evaluate the fundamental functionality of the device and confirm the validation in a pilot clinical study in collaboration with Dr. Casey Chen at University of Southern California. 100 teeth (5-10 patients) with moderate periodontitis (pocket depth: 4-6 mm) will be evaluated with PUPI and manual probing method before and 4-week after the nonsurgical treatment (i.e., scaling and root planning). That will give us 80% statistical power assuming an alpha of 0.05 based on our preliminary data. Our goal is to build a handpiece that can easily scan the entire oral cavity. We will test the designed miniaturized handpiece using an oral care manikin. We hypothesize that the correlation coefficient between probing and PUPI is R2 > 0.8. We also hypothesize that the PUPI will show a significant difference in pocket depth, clinical attachment loss, gingival biotype and inflammation before and four weeks after treatment (p <0.05). This approach is innovative because for the first time, the miniaturized handpiece of PUPI will provide anatomical and functional information of the entire gingiva architecture. In addition, PUPI will enable accurate diagnostics and therapy monitoring which add enormous value for recommended treatment and ensure best outcomes. The clinical impact is the proposed device will assist dentists and periodontists to accurately diagnose gingivitis in the early stage and reduce the rate of advanced periodontitis. This work will introduce a non-invasive and non- ionizing dual modality imaging technique which has significant impacts on oral health care.

项目摘要 本提案的目的是设计和验证牙周超声/光声成像（PUPI） 一种可以非侵入性地测量牙周袋深度、临床附着丧失的装置， 牙骨质-牙釉质交界处（CEJ）位置、牙龈生物型和炎症。当前牙周评估 这些方法是不准确的，因为它们是基于视觉检查和牙周探测。当放射线照相术 提供有关硬组织（如骨骼和牙齿）的详细信息， 在放射摄影中通常会被遗漏。超声/光声方法已经用于软组织成像， 在牙科中很少，因为它们具有限制整个口腔扫描的大尺寸换能器。这是一 现有技术的根本局限性。为了解决这个问题，StyloSonic LLC将构建并验证 一种小型化手持件，带有用于超声/光声成像的紧凑型激光二极管， 牙周指标PUPI提供实时、准确和可重复的测量，可用于诊断和 治疗监测这就是这项建议的价值所在。该工作流程将包括两个部分： 目标1将设计和制造PUPI原型，目标2将评估 设备，并确认在一项试点临床研究中与凯西陈博士在大学合作的验证。 南加州。将对100颗中度牙周炎（牙周袋深度：4-6 mm）的牙齿（5-10名患者）进行 在非手术治疗前和治疗后4周用PUPI和手动探测法进行评估（即，缩放 根规划）。这将使我们有80%的统计能力，假设α为0.05，基于我们的初步 数据我们的目标是制造一种可以轻松扫描整个口腔的手机。我们将测试设计的 使用口腔护理人体模型的小型化手持件。我们假设， 探测和PUPI是R2 > 0.8。我们还假设，PUPI将显示口袋中的显著差异， 治疗前和治疗后4周，临床附着丧失，牙龈生物型和炎症（p <0.05）的范围内。 这种方法是创新的，因为PUPI的微型手柄将首次提供解剖学上的 和整个牙龈结构的功能信息。此外，PUPI将实现准确的诊断 和治疗监测，为推荐的治疗增加了巨大的价值，并确保最佳结果。的 临床影响是所提出的设备将帮助牙医和牙周病医生准确诊断牙龈炎， 降低晚期牙周炎的发病率。这项工作将介绍一种非侵入性和非- 电离双模态成像技术对口腔保健有重要影响。