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.
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.