Periodontitis, or severe gingivitis, is a common disease that is estimated to affect about 20-50% of the global population – often without any symptoms at all. Now, for the first time, a Finnish study has produced encouraging results in identifying young people at risk of the  disease.

It is estimated that around 10% of young people in Finland have an onset of periodontal disease, but the susceptibility remains throughout life. The incidence of the disease increases significantly between the ages of 20 and 40.

“Therefore, identification of patients at risk should take place at an early age, preferably under the age of 20 when the onset and progression of this dental adhesive tissue disease can still be influenced,” says Ismo T. Räisänen, DDS, PhD, MSc(tech) from the University of Helsinki.

Räisänen has been part of a Finnish research team that has been actively searching for years for ways to overcome the serious gum disease, periodontitis, using modern methods of diagnosis and treatment.

A major focus of research has been the so-called immunological rapid test for active matrix metalloproteinase-8 (aMMP-8) developed by Professor Timo Sorsa of the Department of Oral and Maxillofacial Diseases at the University of Helsinki. It can be used to detect whether a periodontal breakdown of gum tissue is underway in a person's gum pockets even before it can be seen visually.

The effect of antibacterial photodynamic therapy (aPDT) in the prevention and treatment of gum infections including periodontitis and peri-implantitis has also been extensively studied and has also produced a large body of positive clinical evidence.

The Lumoral method, which is based on aPDT light therapy, hampers plaque formation and significantly reduces the amount of periodontal bacteria in the mouth. Elderly people, for example, are particularly well suited to the teeth cleaning method's user profile, as optimal oral self-care is critical in this age group. 

Dr Räisänen's recent thesis Risk factors and active matrix metalloproteinase-8 (aMMP-8) diagnostics for initial periodontitis in adolescents provides further confirmation of the usefulness of the aMMP-8 mouthrinse point-of-care (PoC) test for the identification of initial periodontitis in adolescents. Among other things, the study found that while saliva and mouthrinse are both useful in aMMP-8 diagnostics, mouthrinse appears to be more accurate than saliva.

The aMMP-8 test can be used to help assess the risk of the onset and progression of periodontitis. The aMMP-8 test can also be used to monitor the effectiveness of periodontal treatment by a professional.

“Based on the results of the thesis, it would be useful for every young person to have an aMMP-8 test done at least once before the age of 20, especially if they have other risk factors for periodontal disease.”

Test result in minutes

MMP-8 is an enzyme produced mainly by neutrophils, the most common white blood cells in humans. It plays a key role in inflammatory processes in the body. However, in the case of periodontitis, the inflammatory process of the body results in the activation of the MMP-8 (aMMP-8) enzyme and the breakdown of periodontal tissue that helps keep teeth in place.

The five-minute test that can help measure the risk of active periodontal adhesion tissue loss and its progression helps complement the diagnosis, outcome monitoring and maintenance treatment of periodontitis and peri-implantitis.

“At the same time, it enables early referral of young people at risk of developing severe gum disease for further investigation and treatment,” Räisänen explains.

Early signs of periodontal disease include red and bleeding gums and halitosis. Once established, the disease is a 'tenacious' companion that progresses if not treated carefully.

The cornerstone of treating gum disease is good oral hygiene, which requires professional help, as the oral biofilm that has hardened into tartar must first be removed from the tooth surface and gum pockets. This is followed by cleaning of the teeth through careful oral hygiene to prevent the formation of new tartar in the gum pockets.

According to the National Institute for Health and Welfare (THL), more and more people in Finland brush their teeth at least twice a day. However, there are still gaps in oral self-care. Although brushing teeth and interdental spaces is an effective way to clean teeth, studies show that brushing leaves up to half of the plaque on the tooth surface.

Careful prevention pays off

Räisänen stresses that prevention and timely treatment of periodontal disease are important both for the health of individuals and economic well-being of society.

The treatment of periodontitis, especially severe periodontitis, is expensive and ties up a lot of resources. It is also important to be aware that the harmful effects of periodontal disease are not limited to the mouth and teeth. It is linked to a number of underlying diseases such as diabetes, cardiovascular disease, pulmonary disease, various cancers and also to complications of COVID-19. According to one scientific study, a first heart attack is 30% more common in people with periodontal disease than in healthy people of the same age.

“Now is the time to start investing in oral disease prevention as public health care resources are already stretched. Early detection and treatment of periodontal disease is cost-effective at all ages. Good oral health is part of overall health and improves patients' quality of life,” says Anna Maria Heikkinen, Professor of Clinical Dentistry, Associate Professor of Clinical Periodontology, University of Tampere, Specialist Dentist in Healthcare and Clinical Dentistry.

According to Heikkinen, identifying young people at risk of periodontal disease can reduce over- and under-treatment. Individual risk factors should be taken into account and a oral home care plan should be drawn up for each individual on this basis, using appropriate dental care tools.

“This is cost-effective and can save money in the future by reducing the cost of treating adult periodontitis. Investing in young people is an investment in the future!”

Heikkinen says that, as research leader, she will launch a follow-up study in autumn 2023 to assess the oral health of young people, combining aMMP-8 diagnostics with antibacterial Lumoral treatment. The aim is to gain a broader understanding of how aPDT treatment, when used regularly, affects the oral health of adolescents.

Recent results in the adult population have been encouraging and more are expected later this year on the use of aPDT (Lumoral) in the treatment of oral diseases.

“We need information on how individualised prevention of oral diseases, both periodontal disease and tooth decay, can be improved and targeted with new methods in addition to standard home self-care in adolescents. The benefits of new innovations need to be examined through research before they are more widely adopted,” says Heikkinen.

In the adult population, there have recently been encouraging results on the use of aPDT (Lumoral therapy) in the treatment of oral diseases.

“Therefore, it is justified to investigate the benefits of aPDT in the prevention and treatment of incipient periodontitis and, why not, caries as well in adolescents. The impact will be evaluated in addition to and in support of normal self-care activities such as brushing teeth, cleaning between teeth and regular visits to the dentist and oral hygienist,” concludes Räisänen.

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International Gum Health Day celebrated on 12 May 2023

Gum Health Day, promoted by the European Federation of Periodontology (EFP), the umbrella organisation for periodontology in Europe, is celebrated annually on 12 May.

The aim of this anniversary, which highlights the importance of oral health, is to raise awareness among health professionals and the general public of the need for prevention, early diagnosis and treatment of periodontal and peri-implant diseases, and to highlight the importance of periodontal health as part of good general health.

The slogan for this year's Health Day is "Healthy gums look good. Protect them!". This is to highlight the importance of periodontal health as part of good general health, without forgetting the importance of aesthetics.

Koite Health Oy is a Finnish health technology company that develops light-activated antibacterial solutions for the treatment and prevention of oral diseases. The company’s Lumoral teeth cleaning method can be used at home by children and adults to prevent tooth decay and gum diseases and treat even the most severe cases of gum disease including periodontitis.

Mikko Kylmänen, Clinical Research Project Manager at Koite Health, explains the importance of high standard clinical research and the different stages that took place before the innovative Lumoral method for oral self-care became available to consumers.

Why is clinical research needed?

Clinical research is needed to ensure that healthcare devices on the market are safe to use, are fit for their intended purpose and meet the characteristics and performance standards required. When clinical trials are conducted to a high standard and based on scientific evaluation, both users and healthcare professionals can have confidence in the quality and performance of the medical device.

The development of medical technologies is based on multidisciplinary research, which continues actively even after the product has been launched on the market. The effect of regular use of Lumoral has been – and still is – the subject of multiple clinical trials, for example, in the treatment of dental implant-related infections. The results have been promising: plaque amount and gum bleeding around the inflamed gum tissues of patients were significantly reduced compared to the initial situation. More research on this topic is expected to be released later in 2023. 

In December 2022, Koite Health published the interim report of a large periodontal study in an international dental journal. 

– The findings were so significant that we wanted to bring them to the attention of the professional and scientific communities, and also Lumoral users as soon as possible. At the same time, seeing these results gave us at Koite Health more information about the performance and safety of the device. The new information also can be used when new studies are planned, Mikko Kylmänen concludes.

Standards are the basis for clinical research

According to Kylmänen, international standards are the cornerstone of clinical trial designs for Lumoral. These include ISO 14155 GCP (Clinical Trials on Medical Devices - Good Clinical Practice) and the European Union's Medical Device Regulation EU 2017/745 (MDR). 

A Lumoral clinical trial must have clear goals and objectives, either to ensure the effects of the treatment as already authorised, or to find new uses for Lumoral. Strict compliance with regulations will ensure that the safety of the study subjects is not compromised. 

– As a rule, our studies are randomised controlled trials between two study groups - the Lumoral group and the control group. Participants in both study groups will undergo exactly the same clinical measurements and will be given exactly the same self-care instructions. The only difference between the two groups is that one group uses Lumoral during the study and the other does not.

Randomisation means that the study group for a subject is randomly selected and neither the subject nor the researcher knows which group the subject belongs to before the study starts.

The company has sometimes been asked why it does not conduct placebo-controlled trials with Lumoral. According to Mr Kylmänen, it is quite common internationally that in device studies, subjects in one group have the device and not the other. Placebo-controlled studies are better suited to medical trials.

Brainstorming of studies is a collaborative process 

The best ideas for studies often come from open discussion with professionals such as dentists, oral hygienists or researchers. These discussions gradually lead to the development of a research outline, which is then refined by researchers in collaboration with the professionals involved in the individual study.

According to Kylmänen, involving professionals in Lumoral studies at an early stage is crucial because they know best the needs of their own speciality.  

– We always try to take into account the typical treatment frequency of the respective disease at the clinic. When planning this way, there is as little extra effort as possible for the study subjects.

Careful preparation is required to obtain authorisation for studies

All study plans for Lumoral studies – including the materials to be provided to subjects and the documentation related to data protection - are subject to an application to a research ethics committee for an opinion. As a rule, the committee is selected according to where the study will be conducted. Issues such as data protection are also carefully considered at this stage. 

When the committee finally gives its opinion, it is the turn of the Finnish Medicines Agency (Fimea), or equivalent authority in other countries, to give approval to start the clinical study. Fimea's tasks include the supervision of medical devices in Finland under the MDR Regulation. Clinical trials of devices are also subject to supervision.

– If Fimea requires changes to the study plan, the changes must be resubmitted to the Ethics Committee, either as a new application or as a notification. Overall, the application process for regulatory approvals in Finland takes at least three months. Usually even longer. After that, approvals are still needed from the clinics where the research will be carried out.

Contracts are concluded according to need and local practice

Various contracts can be concluded with researchers and clinics, depending on need and local practice. Often a local research authorisation also requires a research contract to be drawn up. 

– We also take care of the costs of the sponsored studies, and these are written into the contracts. We also have contracts with so-called CROs (contract research organisations), from whom we buy research monitoring services, says Kylmänen.  

Good clinical practices guide Lumoral studies

One of the most important principles of clinical research is that no measurement or procedure related to the study should be performed on any patient without their written consent. 

According to Kylmänen, good clinical practice in Lumoral trials also includes training and ensuring the competence of the research team and providing background support for researchers throughout the trial. The MDR regulation, on the other hand, requires close monitoring of the benefits and potential harms of the device. 

– Of course, this is also in our interests from the point of view of the device developer, Kylmänen stresses.

Quality control is an important part of clinical research

For each trial, an individual quality control or monitoring plan is drawn up. This covers among other things, the consent collection process, and recording and reporting of adverse events. It also covers the review of trial data before the trial results are analyzed. 

Monitoring is one of the most important steps in the overall safety and scientific credibility of a clinical trial, according to Kylmänen.

Clinical research is like a marathon

Kylmänen points out that science is complex. Even if "your own thing" may seem clear to you, you may have to explain it in great detail to other scientists – even co-scientists.

– Even the most thorough explanation does not necessarily guarantee that everyone will believe you. Research results come slowly. If a study starts today, it could be two or more years before it reaches the publication stage. In fact, I now think of a clinical trial as more than just a single marathon. It is a series of marathons. Like running in slightly different landscapes repeatedly. And even if you reach one goal, there may be several journeys yet to be completed and new ones to meet.

– However, I must add that the launch of Lumoral to the market did not happen by chance. The idea to develop an antibacterial teeth cleaning Lumoral method was based on scientific evidence from the outset. It took three years from the initial concept to the launch of the current product. Now the final product  is unlike anything we have ever seen before. Helping to bring clinic-level treatment to a relatively hassle-free home-based treatment. Without compromising on quality.

Finnish health technology group Koite Health will participate in the upcoming third edition of the Igienista Dentale 3.0 (Dental Hygienist 3.0) congress on March 4, 2023, in Rome, Italy. The now sold-out congress will return to the prestigious venue of the Tor Vergata University in Rome after a break since 2020 due to the COVID pandemic.

The Igienista Dentale 3.0 event is focused primarily on dental hygiene professionals. The congress comes only shortly before Germany's IDS Cologne event where Koite Health will also showcase its Lumoral-method – an innovative technology designed to enhance oral home care for the prevention and treatment of gum diseases and dental caries.

– Our goal is to increase the visibility of the Lumoral brand and identify potential commercial partners, says Koite Health's Chief Commercial Officer Tero Pasanen.

– Italy is an important market for Lumoral. We aim to expand to some of the largest nations in the European Union as fast as possible. This way we can offer our European customers access to better oral hygiene. Through our expansion we seek to give patients who suffer from periodontitis a chance to stop the progression of the disease and to help tackle the ever-growing problem of peri-implantitis, Pasanen adds.

Lumoral will be represented at the Italian event by Italian dental hygienist professional Gianfranco Panzironi.

Panzironi has written a scientific paper titled "Home photodynamic therapy as a means of prevention for biofilm control" that explores the role of dental plaque in causing oral problems and the benefits of Lumoral in prevention of oral problems.

– Prevention is the pillar against oral diseases and compliance with correct oral hygiene techniques is essential to preserve the normal microbiome and maintain the health of the oral cavity. Among the new technologies that allow the patient to control the biofilm comfortably and effectively, a device for the home application of antibacterial photodynamic therapy stands out.

Lumoral is a cutting-edge medical device that is designed to improve oral hygiene and significantly improve oral health. Lumoral offers anti-inflammatory treatment for various groups of patients – even those with difficult-to-treat oral conditions such as severe gum disease, and periodontitis. Lumoral is scientifically proven to be the best available home care treatment for periodontal patients and implant maintenance.

IDS 2023 will be organised from 14 to 18 of March in Messe Cologne. Koite Health recently signed a distribution agreement with white cross GmbH, a German distribution and training company specializing in oral health prevention. Following the agreement white cross will focus its marketing efforts on over 55.000 dentistry professionals in the German market to promote the use of Lumoral.