Noninvasive Dental Implant Imaging System

描述(申请人提供)：牙科种植体具有非常高的存活率，是牙科领域发展最快的领域。但是，较高的并发症发生率会导致严重的并发症、费用和失望。术前更好地了解软组织厚度和硬组织轮廓可以显著降低并发症发生率。目前用于种植手术的软组织厚度测量技术涉及到用探头或X线片对脆弱组织的机械穿透有些不准确，这对于软组织测量并不是最理想的。提出了一种非侵入性超声成像系统，它可以通过以下方式潜在地改进种植程序：术前准确的非侵入性测量软组织厚度，包括移植物；识别重要的表面骨骼特征，如孔洞；在拔牙前或种植后识别牙齿上的骨缺陷或裂隙；促进术中初始钻头的重新定向 发生穿孔；通过测量覆盖的软组织精确定位埋藏的愈合植入物。超声波非常适合于这一目的，因为：它可以在手术前或手术期间实时使用；数据位于牙医直接看到的患者身上成像的准确位置；它是非侵入性的，没有电离辐射；它可以用廉价的便携式仪器进行。如果成功，超声波系统有望通过减少手术、美容和假肢并发症所需的昂贵辅助程序来降低植入治疗的总体社会成本。此外，该系统将提高常规种植结果的质量和可预测性(特别是促进微创无瓣手术)--这对牙医和患者都很重要。这项第二阶段SBIR工作的目标是展示定制的非侵入性超声成像系统ImSight在牙科种植手术中的临床效果。该提案将侧重于定制ImSight探测器的制造、体外学习研究、探测器实施的体外优化研究、临床试验以及ImSight设备的管理测试。该系统将用于牙科植入物手术放置前的治疗计划、手术植入物放置期间、随后的手术发现期间以及长期监测。 公共卫生相关性：种植牙的存活率非常高，是牙科领域增长最快的领域，但目前受到高并发症发生率的困扰，导致 需要大量的辅助手术，功能和美容效果不是最理想的。非侵入性超声成像系统能够准确识别和测量软组织厚度、骨缺陷、牙齿和种植体裂开、颧孔和其他孔、颌骨形态以及埋藏愈合植入物的准确位置，从而有可能改进现场评估、治疗计划、外科手术程序、发现和监测。如果成功，这种廉价的系统有望降低种植治疗的总体社会成本，促进微创无瓣手术，并提高常规种植结果的质量和可预测性--这对牙医和患者都很重要。

DESCRIPTION (provided by applicant): Dental implants have very high survival rates and are the fastest growing field in dentistry. But, high complication rates result in significant morbidit, cost, and disappointment. Better pre-operative knowledge of soft tissue thickness and hard tissue contour could dramatically cut complication rates. Current soft tissue thickness measurement techniques for implant procedures involve somewhat inaccurate mechanical penetration of delicate tissues with probes or radiography which is not optimal for soft tissue measurement. A noninvasive ultrasound imaging system is proposed that can potentially improve implant procedures by enabling: accurate non-invasive preoperative measurement of soft tissue thickness, including grafts; identification of important surface bony features such as foramina; identification of bony defects or dehiscences on teeth before extraction, or implants after placement; facilitate intra-operative redirection of the initial drill should a cortical bony perforation occur; and precise location of buried healing implants with measurement of overlying soft tissue. Ultrasound is ideally suited to this purpose because: it can be used in real-time before or during surgeries; data is located to the exact site being imaged on the patient, as directly viewed by the dentist; it is non-invasive and without ionizing radiation; and it can be performed with an inexpensive portable instrument. If successful, the ultrasound system is expected to lower the overall societal cost of implant therapy by decreasing the need for expensive adjunctive procedures necessitated by surgical, esthetic and prosthetic complications. Additionally, the system will improve the quality and predictability of routine implant outcomes (especially facilitating minimally invasive flapless surgery) - important to both dentists and patients. The objective of this Phase II SBIR effort is to demonstrate the clinical efficacy of a customized noninvasive ultrasound imaging system, ImSight, for dental implant procedures. The proposal will focus on fabrication of customized ImSight probes, in-vitro learning studies, in-vitro optimization studies of probe embodiments, clinical trials, and regulatory testing of the ImSight device. The system will be used for treatment planning prior to surgical placement of dental implants, during surgical implant placement, during their subsequent surgical uncovery, and for long-term monitoring. PUBLIC HEALTH RELEVANCE: Dental implants have very high survival rates and are the fastest growing field in dentistry, but are currently beset by high complication rates resulting in the need for a great many adjunctive procedures and less than optimal functional and esthetic outcomes. A noninvasive ultrasound imaging system has the potential to improve site assessment, treatment planning, surgical procedure, uncovery, and monitoring, by enabling accurate identification and measurement of soft tissue thicknesses, bony defects, tooth and implant dehiscences, mental and other foramina, jawbone form, and the precise location of buried healing implants. If successful, the inexpensive system is expected to lower the overall societal cost of implant therapy, facilitate minimally invasive flapless surgery, and improve the quality and predictability of routine implant outcomes - important to both dentists and patients.