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Luke Co., Ltd. World’s first periodontal disease treatment device receives medical device approval

[Luke Co., Ltd.] World’s first periodontal disease treatment device receives medical device approval

*View in browser* *Luke Co., Ltd.*
Press release: June 3, 2024
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World’s first periodontal disease treatment device receives medical device approval
*~Developed by a venture from Tohoku University, paving the way for a new era of periodontal disease treatment~*
Luke Co., Ltd. (Head office: Sendai City, Miyagi Prefecture) An innovative periodontal disease treatment device jointly developed by Tohoku University research department (Representatives: Taro Kanno, Tomohisa Sugimoto) has been approved as a medical device for the first time in the world. This new periodontal disease treatment device “Blue Radical”
By linking the highly efficient radical sterilization technology installed in “P-01” with the behavior change application “Perimil” that connects the device and IoT, we will create a new solution for periodontal disease, which is the world’s No. 1 infectious disease and lifestyle-related disease. We propose solutions from a unique approach.

* ■Development background*
* Research background on the relationship between periodontal disease and general health and motivation for developing new treatment methods *
Periodontal disease is an inflammatory disease and infection of the periodontal tissue caused by bacteria in dental plaque that
accumulates in periodontal pockets.
Periodontal disease is a common disease that can affect many people, as recognized by the Guinness Book of World Records in 2001 as the “most prevalent disease in the world,” but recent research has shown that periodontal disease is Significant associations have been shown between periodontal disease and chronic diseases such as
cardiovascular disease, diabetes, and even Alzheimer’s disease. These diseases are often caused by chronic inflammatory reactions, and it has been revealed that periodontal disease bacteria play a role in worsening systemic inflammatory conditions through the bloodstream. In this way, dealing with periodontal disease is a major issue in realizing a healthy society that starts with dentistry.

So, why are there so many people suffering from periodontal disease in Japan despite having an infrastructure of over 68,500 (*1) dental clinics?

As one of the answers, we believe that periodontal disease is caused by the patient losing interest in teeth (neglect).
This led me to believe that there are limits to how we can strongly approach this root cause with current treatment at dental clinics and regular maintenance alone. In other words, we believe that a new approach that combines the following two methods is necessary to control periodontal disease.
1. Approach to teeth: thorough treatment and plaque control within teeth and periodontal pockets
2. Approaching people: Changing patient behavior from “not being interested” to “staying interested” in teeth
Mechanism of onset of periodontal disease Excerpt from our website Against this background, Luke Co., Ltd. and Tohoku University’s research department have jointly developed Blue Radical, a new periodontal disease treatment device that can address these two issues at the same time.
P-01” and the patient behavior modification app “Perimil”. *1: Excerpt from Ministry of Health, Labor and Welfare medical facility survey https://www.mhlw.go.jp/toukei/saikin/hw/iryosd/19/dl/02sisetu01.pdf

* ■Detailed explanation of new technology*
* What is the world’s first periodontal disease treatment device “Blue Radical P-01”? *
“Blue radical”
P-01 is a periodontal disease treatment device that can kill 99.99% of oral bacteria that cause periodontal disease. With conventional treatment methods that only use ultrasonic vibration, especially in cases of severe periodontal disease, bacteria are often left behind, necessitating tooth extraction and administration of antibiotics.

“Blue Radical P-01” uses “radical sterilization” using 3% hydrogen peroxide solution and 405nm blue laser irradiation.
Radical sterilization is the world’s first technology to successfully sterilize the inside of dental plaque (*2) in a short period of time. Ultrasonic vibration within the periodontal pocket
×
By performing radical sterilization, it is possible to sterilize 99.99% of oral bacteria, making it a new treatment device that can increase the possibility of saving teeth even with severe periodontal disease even with non-surgical treatment.
*2: Details about demonstration results
https://www.sciencedirect.com/science/article/abs/pii/S0924857916301637?via%3Dihub

“Radical sterilization” is performed using hydrogen peroxide and blue laser irradiation from the tip of the ultrasonic vibrating tip. * What is the patient behavior change app “Perimil”? *
“Perimil” aims to make patients habitual of taking an interest in their own oral cavity, eliminate the cause of periodontal disease (patient’s own neglect and neglect), which is a lifestyle-related disease, and encourage behavioral changes. This is an app for patients.

Specifically, “Perimyl” is called “Blue Radical P-01”.
By linking with “, patients can check their treatment time and progress on their smartphones, and see illustrations of the risks of each tooth and overall inflammation status. You can also receive tooth brushing instructions from the dental hygienist who sends you comments from time to time, and you can receive support for developing a brushing habit using the tooth brushing timer. It enables
communication between patients and dental clinics even when they are not at the dental clinic until their next appointment, making it a useful tool for health support in modern society.
By combining these, “blue radicals”
P-01″ to provide highly efficient and minimally invasive periodontal disease treatment by sterilizing dental plaque, and to make it a habit for patients to prevent the accumulation of dental plaque on their own through a behavioral modification method using “Perimil”. I can. In other words, by approaching both people and teeth at the same time, we propose a new solution to periodontal disease, which is both an infectious disease and a lifestyle-related disease.

* ■The history of clinical trials, the pinnacle of clinical trials, and the approval of the world’s first dental medical device * Luke Co., Ltd. and Tohoku University’s research department have worked closely with the Ministry of Health, Labor and Welfare from the early research stages to carefully consider how to conduct the clinical trial.
Medical device approval is granted after the Ministry of Health, Labor and Welfare rigorously examines the device’s safety and clinical efficacy, including clinical trial data and manufacturing environment.

* Clinical trial results *
We conducted a clinical trial, the pinnacle of clinical trials, and found that in teeth with severe periodontal disease, periodontal disease treatment using this treatment device reduces periodontal disease bacteria and shallows the periodontal pocket more than conventional treatment methods. It has been proven to be highly effective and is the world’s first periodontal disease treatment device.
It has been approved as a medical device that claims to be effective for periodontal disease*.
The results were highly praised, and a paper summarizing the clinical trial was published in Scientific Reports, a journal supervised by the world-renowned journal Nature. (*3)
*3: Published Scientific Reports article
https://www.nature.com/articles/s41598-017-12514-0
Comparison of effects between conventional treatment methods and radical sterilization: Progress of improvement in periodontal pocket depth in 3 months
* ■Message from the representative*
Mr. Taro Kanno, Representative Director, Luke Co., Ltd., Professor, Tohoku University Graduate School of Dentistry, Doctor of Dentistry, Dentist, MBA
“It has been 17 years since the seed was first conceived, and our project has finally reached the day of social implementation in Japan, ahead of the rest of the world.In the medical business, which is a once-in-a-lifetime event, we are truly honored to be able to experience this day. This is a miracle, and I would like to first of all express my sincere gratitude to the many people who supported this.
“Blue Radical”, which makes full use of the latest cutting-edge technology and IT based on Japanese manufacturing.
We are confident that “P-01” and “Perimil” will bring major changes to patients and dental care.
Please everyone, please try this new treatment!
As a result, if disease turns into ease, we believe that this is the price we as a team of dentists have paid for our long years of development. ”
* ■About Luke Co., Ltd. *
Luke Co., Ltd. is a venture company originating from Tohoku University that aims to socially implement cutting-edge, scientifically based technology through joint research with universities.
Since our team consists mainly of dentists, we ask ourselves how much the disease can be improved by the services we provide. Keeping this perspective in mind, we continue to focus on “Release” for the benefit of patients.
from “Dis-”
With the vision of “freeing people from the obstacles that get in the way of enjoying life,” we hope to help patients turn their disease into ease. In this way, Luke Co., Ltd. will continue to contribute to society by providing sustainable health solutions.

* ▼Contact for inquiries*
Company name: Luke Co., Ltd.
Person in charge: Sato
E-mail: info@luke-br.com
TEL: 022-347-4142
*About details about this release*
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