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）：II期项目的标题为“仪器系统和微创牙周手术”（MIS）的技术，旨在（1）进一步开发在I期努力中创建的仪器系统，（2）在临床研究中证明了仪器系统的临床功效和MIS。在第一阶段的努力中开发了两种仪器技术：（a）一种“飞行射击”装置，该设备附在内窥镜上，以防止牙周手术期间内窥镜的雾化和结垢，以及（b）旋转装置，用于拆卸肉芽组织，用于通过临时性进行临时性的小型外科手术。手术系统在人类手术期间使用时，手术系统的有效性以及测量微创手术程序的结果。安全研究将衡量空袭将空气引入外科组织（称为组织肺气肿）的可能性，并且颗粒组织去除仪器可能会刮擦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的头上进行，肉芽组织去除研究将在提取的人牙上进行。这两项研究都将在达拉斯牙科设计的设施中进行。人类临床研究将在贝勒牙科学院的牙周系进行。使用在第一阶段开发的手术系统对三十例患者进行的最低侵入性再生手术。将分析长期结局和患者改善。许多健康益处与开发易于使用的仪器系统进行牙周再生手术有关。已经证明MIS会导致患者的疼痛减轻，更快的愈合和改善的长期健康结果。3，4此外，易于使用的仪器系统可通过使非专家进行MIS来增加医疗服务的机会并降低治疗成本。 公共卫生相关性：第二阶段项目的标题为“仪器系统和微创牙周手术”（MIS）的技术，旨在创建一种手术仪器系统，该仪器系统将促进旨在重新生长组织（骨骼，韧带，牙龈等）的非常小的切口牙周手术的性能。与传统的侵入性外科手术技术相比，医学中的小切口手术已显示出减轻疼痛，更快地恢复常规活动，并改善了长期手术后的外科手术结果。最低侵入性的牙周手术的使用已显示出相似的益处，可能会对牙周疾病患者产生同一患者和公共卫生的益处。