Instrument System and Technique for Minimally Invasive Periodontal Surgery (MIS)

微创牙周手术 (MIS) 仪器系统和技术

• 批准号: 8064802
• 负责人: Stephen K. Harrel
• 金额: $ 34.68万
• 依托单位: DENTAL DESIGNS OF DALLAS
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-04-01 至 2013-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8064802
• 关键词: Abattoirs; Air; Animals; Bone Tissue; Clinical; Clinical Research; Clinical Treatment; Data Collection; Dental Facilities; Dentistry; Development; Devices; Endoscopes; Fogs; Funding; Goals; Granulation Tissue; Head; Healed; Health; Health Benefit; Health Services Accessibility; Human; Ligaments; Manufacturer Name; Marketing; Measures; Medicine; Methods; Minimally Invasive Surgical Procedures; Natural regeneration; Operative Surgical Procedures; Optics; Outcome; Outcome Measure; Pain; Patient Care; Patient Recruitments; Patients; Performance; Periodontal Diseases; Phase; Procedures; Production; Public Health; Pulmonary Emphysema; Research; Safety; Science; Small Business Innovation Research Grant; Surgeon; Surgical Instruments; Surgical incisions; Surveys; System; Techniques; Technology; Testing; TimeLine; Tissues; Tooth Tissue; Tooth structure; Treatment Cost; United States National Institutes of Health; base; clinical efficacy; college; commercialization; design; effectiveness measure; healing; improved; instrument; instrumentation; minimally invasive; phase 1 study; prevent; programs; public health relevance; regenerative; safety study; success; tooth surface

DESCRIPTION (provided by applicant): The Phase II project entitled Instrument System and Technique for Minimally Invasive Periodontal Surgery (MIS), is designed to (1) further develop the instrument system created in the Phase I effort and (2) demonstrate the clinical efficacy of the instrument system and MIS in a clinical study. Two instrument technologies were developed during the Phase I effort: (a) an "Airshield" device that attaches to an endoscope to prevent fogging and fouling of the optics of the endoscope during periodontal surgery and (b) a rotary device for removing granulation tissue through the small surgical openings used for minimally invasive periodontal surgery.1, 2 This study will consist of safety studies for the two instruments and a clinical study that will measure the effectiveness of the surgical system when used during surgery on humans as well as measure the outcomes of the minimally invasive surgical procedures. The safety study will measure the possibility of the Airshield introducing air into the surgical tissue (referred to as tissue emphysema) and the possibility that the granulation tissue removing instrument might scratch or damage the tooth surface. The tissue emphysema study will be performed on slaughterhouse animal heads and the granulation tissue removing study will be performed on extracted human teeth. Both of these studies will be performed at the facilities of Dental Designs of Dallas. The human clinical study will be performed at the Periodontal Department of Baylor College of Dentistry. Minimally invasive regenerative surgery will be performed on thirty patients using the surgical system developed during Phase I. The long term outcomes and patient improvement resulting from the surgery will be analyzed. Many health benefits are associated with developing an easily used instrument system for performing periodontal regenerative surgery. MIS has been shown to result in less patient pain, faster healing, and improved long term health results.3, 4 Additionally, an easily used instrument system for MIS will increase access to care and reduce treatment costs by making it possible for non-specialist to perform MIS. PUBLIC HEALTH RELEVANCE: The Phase II project entitled Instrument System and Technique for Minimally Invasive Periodontal Surgery (MIS), is aimed at creating a surgical instrument system that will facilitate the performance of very small incision periodontal surgery designed to re-grow tissue (bone, ligaments, gums, etc.) lost to periodontal disease. Small incision surgery in medicine, when compared to traditional invasive surgical techniques, has been shown to result in less pain, more rapid return to routine activities, and improved long term post surgical results. The use of minimally invasive periodontal surgery has been shown to have similar benefits and will likely result in these same patient and public health benefits for patients with periodontal disease.

描述（由申请人提供）：第二阶段项目名为微创牙周手术（MIS）的器械系统和技术，旨在(1)进一步发展在第一阶段努力中创建的器械系统，(2)在临床研究中证明器械系统和MIS的临床疗效。在第一阶段的努力中开发了两种仪器技术：(a)附着在内窥镜上的“Airshield”装置，以防止在牙周手术期间内窥镜的光学雾化和污染；(b)通过用于微创牙周手术的小手术开口去除肉芽组织的旋转装置。这项研究将包括两种器械的安全性研究和一项临床研究，该研究将测量手术系统在人类手术中使用时的有效性，并测量微创手术程序的结果。安全性研究将测量Airshield将空气引入手术组织（称为组织肺气肿）的可能性，以及去除肉芽组织的仪器可能刮伤或损坏牙齿表面的可能性。组织肺气肿研究将在屠宰场动物头部进行，肉芽组织去除研究将在拔出的人类牙齿上进行。这两项研究都将在达拉斯牙科设计中心进行。人类临床研究将在贝勒牙科学院牙周病学系进行。微创再生手术将使用第一阶段开发的手术系统对30名患者进行。将分析手术的长期结果和患者的改善情况。许多健康益处与开发一种易于使用的仪器系统进行牙周再生手术有关。MIS已被证明可以减少患者的疼痛，更快地愈合，并改善长期的健康结果。3,4此外，易于使用的管理信息系统仪器系统将增加获得护理的机会，并通过使非专业人员能够执行管理信息系统来降低治疗费用。