Optimal Prevention and Control of Periodontal Disease: The Periodontal Pocket Irr

描述（由申请人提供）：牙周病是一种慢性细菌感染，影响牙龈和骨骼周围的支持牙齿。根据美国国立卫生研究院的情况说明书，估计80%的美国成年人患有某种形式的牙周病。牙龈炎是一种较温和的牙龈疾病，是由牙菌斑生物膜引起的，牙菌斑生物膜在牙龈线的底部包围牙齿，导致组织变红，发炎和溃疡，促进出血。如果不治疗，炎症反应可能足以进一步破坏牙齿周围的组织，包括牙周膜和骨，从而形成牙周袋。 研究文献确定了牙龈上和牙龈下冲洗与化疗药物控制牙龈炎和牙周炎的好处和疗效。最佳输送系统的主题，特别是口腔家庭护理，也是任何成功的长期计划的重要因素。很少有研究致力于将少量药物精确地最佳递送到牙周袋。任何牙周治疗的压倒性挑战仍然取决于患者对定期专业和家庭护理的依从性。大多数患者无法保持足够的口腔卫生，以防止疾病复发，导致额外的医疗保健费用。履行机构的项目处理这一问题。 我们正在申请专利的创新引入了一种独特的产品，牙周袋冲洗器（Perio-PI），以受控和定向的方式提供指定数量的化疗剂。Perio首席研究员是一种手持式无线设备，符合人体工程学设计，易于使用，可有效进行龈上和龈下冲洗。弯曲的、发光的、可旋转调节的套管尖端简单地穿透磨牙暗区的牙周袋。这将提高用户的接受度。支持信记录专家对Perio首席研究员的认可，以及其开发和商业化。 I期项目设计为2周、单中心、随机、平行组临床试验。我们将开发、设计、优化和制造足够数量的操作原型，用于试点试验。首先，Perio主要研究者原则证明研究将评价效用、安全性、患者依从性和满意度。其次，与口腔卫生说明和不使用冲洗器的单独冲洗相比，将评估该装置减少牙龈炎症的功效。研究人群将包括60名被诊断为牙龈炎的受试者（平均牙龈指数2（改良牙龈指数）和探诊出血20%）。将使用分层区组随机化方案将男性和女性受试者均匀分布在治疗组中。 我们的研究结果将用于申请更大的II期项目，即确定性临床试验，持续时间更长，并有能力进行疗效分析。该项目的意义在于它引入了一个新的方向：研究和开发用于预防和控制牙周病的最佳递送装置。 公共卫生相关性：最近的流行病学研究表明，牙周病是一种慢性炎症性疾病，它破坏了支持牙齿的骨骼和牙龈组织，影响了多达80%的美国成年人（NIH估计），以及其他健康问题，包括心脏病，中风，糖尿病，早产儿低出生体重，类风湿性关节炎和慢性肾脏疾病。大量的研究表明，结合定期的专业牙齿牙周维护，口腔家庭护理的日常方案，包括用专门递送到患病部位的未稀释的化学治疗剂进行龈下冲洗，定期破坏细菌植物群，从而减少牙龈炎症并改善整体健康。我们正在申请专利的创新，人体工程学设计的牙周袋冲洗器（Perio-PI），旨在方便使用，有效的龈下冲洗，介绍了一种独特的产品，提供精确测量的数量，非稀释化疗剂在一个控制和指导的方式。

DESCRIPTION (provided by applicant): Periodontal disease is a chronic bacterial infection that affects the gums and bone that surrounds supported teeth. According to the NIH fact sheet an estimated 80 percent of American adults have some form of periodontal disease. Gingivitis, a milder form of gum disease, is caused by plaque bio-film, which surrounds the teeth at the base of the gum line, causing the tissue to become red, inflamed and ulcerated, promoting bleeding. If left untreated, the inflammatory response may be sufficient to further destroy the tissues, including periodontal ligament and bone, which surrounds the tooth, creating a periodontal pocket. The research literature establishes the benefits and efficacy of supra- and sub-gingival irrigation with chemotherapeutic agents for the control of gingivitis and periodontitis. The subject of optimal delivery systems, particularly for oral home care, is also an important factor in any successful long-term program. There is less research addressing optimal delivery of small quantities of medicaments precisely to the periodontal pocket. The overwhelming challenge for any periodontal therapy remains dependent on patient compliance to both regular professional and home care. Most patients are unable to maintain adequate oral hygiene to prevent recurrence of their disease leading to additional health care expense. The SBI project addresses this subject. Our patent pending innovation introduces a unique product, the Periodontal Pocket Irrigator (Perio-PI) that delivers a specified quantity of chemotherapeutic agent in a controlled and directed manner. The Perio principal investigator is a hand held, cordless device that is ergonomically designed for ease of use for effective supra- and sub-gingival irrigation. The curved, illuminating, rotatively adjustable, cannula tip simply penetrates the periodontal pockets in the dark areas of the molars. This will promote enhanced user acceptance. Letters of Support document experts' acceptance of the Perio principal investigator its development and commercialization. The Phase I project is designed as a 2 week, single-center, randomized, parallel group clinical trial. We will develop, design optimize and manufacture an operational prototype in sufficient quantity for the pilot trial. Primarily, the Perio principal investigator proof of principle study will evaluate utility, safety, patient compliance and satisfaction. Secondarily, the efficacy of the device for reducing gingival inflammation will be assessed compared to oral hygiene instructions and rinse alone without the irrigator. The study population will consist of 60 subjects diagnosed with gingivitis (mean gingival index 2 (modified gingival index) and bleeding on probing 20 percent). Male and female subjects will be evenly distributed across treatment groups using a stratified block randomization scheme. Our results will be used to apply for a larger Phase II project, the definitive clinical trial, with longer duration and powered for efficacy analysis. The significance of this project is that it introduces a new direction: research and development of an optimal delivery device for prevention and control of periodontal disease. PUBLIC HEALTH RELEVANCE: Recent epidemiologic research has suggested a link between periodontal disease, a chronic inflammatory disease that destroys bone and gum tissues that supports the teeth affecting up to 80 percent of U.S. adults (NIH estimate), and other health issues including heart disease, stroke, diabetes, pre-term low term birth weight, rheumatoid arthritis, and chronic kidney disease. A considerable body of research has shown that in conjunction with regular professional dental periodontal maintenance, a daily regimen of oral home care including sub-gingival irrigation with a non-diluted, chemotherapeutic agent delivered specifically to the diseased sites disrupts the bacterial flora regularly allowing the reduction of gingival inflammation and improved overall health. Our patent pending innovation, the ergonomically designed Periodontal Pocket Irrigator (Perio- PI) designed for ease of use for effective sub-gingival irrigation, introduces a unique product that delivers a precisely measured quantity of non-diluted chemotherapeutic agent in a controlled and directed manner.