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，影响支撑牙齿周围的牙龈和骨骼。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，它包围着牙齿的牙龈线底部，导致组织变红，发炎和溃烂，促进出血。如果不及时治疗，炎症反应可能足以进一步破坏组织，包括牙周韧带和牙齿周围的骨头，形成牙周袋。研究文献证实了化疗药物联合龈上和龈下冲洗治疗牙龈炎和牙周炎的益处和疗效。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。有较少的研究解决最佳输送少量药物精确到牙周袋。任何牙周治疗的巨大挑战仍然取决于患者对常规专业护理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，从而导致额外的医疗费用。SBI项目解决了这个问题。我们正在申请专利的创新引入了一种独特的产品，牙周口袋冲洗器（perioi - pi），它以受控和定向的方式提供指定数量的化疗药物。Perio主要研究者是一种手持式，无绳设备，符合人体工程学设计，便于使用，有效的龈上和龈下冲洗。弯曲的、发光的、可旋转调节的套管尖端直接穿过臼齿黑暗区域的牙周袋。这将提高用户的接受度。支持信文件专家接受的Perio的主要研究者，其开发和商业化。一期项目设计为为期2周的单中心、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可操作原型，以进行试点试验。首先，Perio的主要研究者将评估效用、安全性、患者依从性和满意度。其次，将评估该设备减少牙龈炎症的功效，并将其与口腔卫生指导和不使用冲洗器的单独冲洗进行比较。研究人群将包括60名被诊断为牙龈炎的受试者（平均牙龈指数为2（修正后的牙龈指数），牙诊时出血20%）。男性和女性受试者将使用分层块随机化方案均匀分布在各个治疗组中。我们的结果将用于申请一个更大的二期项目，即确定的临床试验，持续时间更长，并为疗效分析提供动力。本项目的意义在于为牙周病的预防和控制引入了一个新的研究方向：研究和开发一种最佳的输送装置。

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.