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.

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.