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.

According to Swedish researchers, up to 20% of children have a particularly virulent strain of Streptococcus mutans (S. mutans) in their mouths, which has a greater-than-usual ability to cause severe tooth decay. Finnish health technology company Koite Health Oy – named one of the hottest European startups in 2022 – has launched a method for targeted removal of dental plaque to improve children’s declining oral health.

Lumoral Junior – is the latest technology on the market for improved oral health self-care developed to suit children's needs. Lumoral Junior improves children's oral care and provides a good starting point for oral health even in adulthood. The method was developed by Finnish researchers with the aim of eliminating harmful bacteria in the mouth to treat and prevent oral diseases.

Oral diseases differ from many other diseases in that they are largely preventable. Despite this, caries and gingivitis are very common diseases even in children. By influencing oral conditions through diet, oral hygiene and fluoride, children can be assured of good oral health through relatively simple daily activities. 

– Oral health is a balance between the factors that protect against disease and those that make it possible to contract it. Regular eating habits, thorough mechanical brushing of teeth to remove bacteria from the mouth and regular use of fluoride all protect against tooth decay, says Heikki Alapulli, a paediatric dentist at the New Children's Hospital of HUS (Finland's largest health care provider).

Frequent consumption of high-carbohydrate foods or sugary drinks combined with poor oral hygiene are factors that contribute to dental and oral diseases. This is where the Lumoral Junior – an antibacterial oral cleaning method developed for children's needs – comes in helpful.

– We see a lot of young children with very bad teeth at our hospital. Any new ways to improve the self-care of children's teeth are therefore very welcome, Alapulli says.

Keeping oral bacteria under control

S. mutans is one of the most common bacterial species causing tooth decay. Good oral hygiene is essential to prevent these bacteria from multiplying and damaging a child's sensitive teeth. Careful mechanical brushing of teeth and the use of fluoride toothpaste are the foundation of children's oral hygiene. But even the most effective mechanical brushing is not always enough.

Lumoral Junior improves children's oral self-care and is particularly suitable for children who are prone to caries, have incipient caries or have a high S. mutans bacteria population in the mouth.

In a Swedish study published in 2017, up to 20% of children observed had a particularly virulent strain of S. mutans in their mouths. This has a greater-than-normal ability to attach to teeth surfaces, to tolerate acidic conditions in the mouth and cause more severe cases of caries, thus, challenging traditional caries methods.

– Antibacterial oral care does not replace traditional oral self-care, i.e., brushing with fluoride toothpaste and flossing, but the approach can inspire and enable children and parents to take better care of their teeth, says Alapulli.

The main responsibility for keeping children's teeth clean always lies with the adults – at least until the third grade of primary school, Alapulli notes.

– As children's hand motor skills develop, the responsibility for cleaning their teeth can gradually be transferred to them. But the child's oral hygiene must be monitored throughout primary school – right up to the age of 12-13.

Heikki Alapulli, a paediatric dentist at the New Children's Hospital of HUS (Finland's largest health care provider)

Antibacterial treatment works when mechanical brushing is not enough

Lumoral Junior reduces plaque formation and can be used to prevent oral bacterial diseases such as tooth decay and gingivitis. It can also be used to prevent oral mucositis caused by chemotherapy. The device is intended for regular use. Recommended use for the prevention of tooth decay is at least twice a week.

Lumoral Junior is intended for children over 3 years of age – the typical age group for use of the device is children aged 4-12 years. Lumoral Junior is only intended to be used in combination with the light-activated Lumorinse mouth rinse that attaches to the plaque of the teeth.

– Lumoral Junior improves children's self-care of their teeth even when traditional methods are not enough or when an existing oral disease requires more than just mechanical brushing and flossing, says Tommi Pätilä, a surgeon at HUS New Children's Hospital in Helsinki, Finland, and one of the developers of the antibacterial oral care method.

– Mechanical teeth cleaning methods are the key to good oral health. However, it is important to remember that brushing only removes 50-60% of plaque at best. The Lumoral Junior antibacterial method is a very effective yet gentle way of removing plaque. It also slows down the formation of new plaque, Pätilä continues.

Tommi Pätilä, a surgeon at HUS New Children's Hospital in Helsinki, Finland, and one of the developers of the antibacterial oral care method.

Good oral health protects the heart

It is important that the child's permanent teeth can develop without having been infected by caries. This makes it very likely that the child will continue to have good oral health in the future. Studies show that it also protects the child from cardiovascular disease in adulthood as well.

– Later in life, a heart attack occurs when the blood supply is cut off from the heart muscle, usually because of a blood clot.  Researchers found dental bacteria in most of these clots.  Thus, the importance of good oral health in managing the risk of heart disease cannot be overemphasized, Pätilä explains.

Alapulli points out that many long-term illnesses are associated with an increased risk of oral disease and that most oral diseases originate in dental biofilms. Dental biofilm is precisely where the antibacterial effect of Lumoral Junior targets.

Alapulli adds that in addition to tooth decay, gingivitis is also common in children if teeth are not cleaned thoroughly enough. Good oral health is also good for the treatment of underlying diseases. However, poor oral hygiene in childhood can be a step on the road to serious gum disease in adulthood, known as periodontitis.

– Habits learned early in life are more likely to be maintained during adulthood and children quickly learn that brushing their teeth every morning and evening is part of their daily routine. It is vital to prevent dental disease especially in children with underlying health conditions. For instance, children with heart conditions are at a higher risk of developing caries. Good oral hygiene is also one of the most important steps in preventing endocarditis, an inflammation of the inner lining of the heart's chambers and valves.

According to Alapulli, one of the major advantages of antibacterial treatment is that it is selective. Lumoral Junior targets hidden plaque on the teeth without disrupting normal oral flora. This is where Lumoral differs from oral anti-inflammatory antimicrobials such as chlorhexidine.

– Chemical mouthwashes also kill the good bacteria in the mouth, and with prolonged use, the mouth gets used to them, Alapulli explains.

– The use of Lumoral Junior facilitates the mechanical removal of biofilm in the child's mouth. It is, therefore, one key component of a thorough oral self-care routine to maintain children’s oral health.

Finnish health technology company Koite Health Oy has signed a cooperation agreement with Swedish dental chain Aqua Dental Ab. The partnership will enable around twenty Aqua Dental clinics across Stockholm and Gothenburg to offer Lumoral, the latest technology on the market for improved oral health self-care, to their patients. 

Meticulous dental self-care is the basis for the prevention and treatment of gum diseases such as periodontitis. Effective mechanical tooth brushing and flossing is, however, usually not enough. 

Lumoral treatment enhances dental self-care, especially when traditional self-care is not sufficient or when an existing oral disease requires more drastic measures than just brushing and flossing alone. 

Lumoral puts clinic-level care in the patient's own hands 

Research shows that Lumoral's antibacterial aPDT phototherapy effectively eliminates harmful oral bacteria while also treating advanced gum disease. Similar light-activated antibacterial treatments have been used in the past, for example in dental clinics. However, the problem has been the cost and the required frequency of these treatments to provide sufficient benefit.  

Koite Health brings a clinic-level treatment method into the hands of its customers. The Lumoral device has also recently been recommended by the Finnish Association of Dental Hygienists. 

– Lumoral has shown promising results both clinically and at the advanced molecular level, says Nilminie Rathnayake, Specialist Dentist and Training Manager, Periodontology at Aqua Dental. 

According to Rathnayake, patients of Aqua Dental clinics have long wished they could improve their everyday dental self-care. 

– The fact that we can recommend Lumoral as a complement to oral self-care seems promising, as research results show that Lumoral has helped achieve excellent results. 

The new collaboration will enable the Swedish dental chain to improve patients' oral health and satisfaction by giving them the opportunity to take control of their oral health by including Lumoral in their daily dental care at home. 

– I believe that this type of daily oral hygiene supplement will mainly help patients with oral diseases such as periodontitis or peri-implantitis. The Aqua Dental chain aims to provide its patients with the best current care for oral diseases. We believe that the partnership agreement with Koite Health is one way of providing our patients with the best possible care. 

A differentiating factor for partner clinics 

According to Sakari Nikinmaa, CEO of Koite Health, the benefits of the partnership agreement are mutual. 

– By working together, we can improve the quality of dental care and give patients the best possible treatment experience and outcomes. Aqua Dental offers its patients a first-class patient experience and level of dental care, which combines perfectly with Lumoral's uniqueness and efficiency, says Nikinmaa. 

According to Nikinmaa, the collaboration will be reflected in joint marketing campaigns in Sweden during the autumn to increase the visibility of Lumoral treatment and awareness of its availability at Aqua Dental clinics. 

– Our staff will also actively educate the clinic staff on the latest research findings, so that they are aware of the latest technologies and have the best knowledge available to treat patients. 

Sakari Nikinmaa, CEO of Koite Health

Niklas Virta, CEO of Aqua Dental, says the new partnership is proof that Aqua Dental is always striving to improve the dental care it offers and wants to be at the forefront of new treatment methods. 

– With Lumoral, we hope to help patients with various oral diseases in a modern and effective way. Research and development is close to our heart, and Lumoral is a means to both influence and prevent the inflammatory process. This is in line with our vision to promote oral and general health, says Virta. 

– We at Aqua Dental look forward to working together. 

Niklas Virta, CEO of Aqua Dental

Helén Huttunen, Product Manager at Koite Health's Stockholm office, is pleased with the new partnership as it is another step towards much needed improvement in dental health in Sweden. 

– Many people suffer daily from some form of bacterial infection in their mouths and poor oral health. To succeed in oral health care, we need to change our habits and get better tools. The link between oral health and heart problems or diabetes has serious consequences. That is why daily oral health is so important. Going to the dentist for annual check-ups is also very necessary, says Huttunen. 

According to Huttunen, the oral health situation in Sweden is challenging. The same is true in other Nordic countries, where waiting lists for dental services are long and public oral health resources are scarce. 

– In northern Sweden, some patients must wait up to six years for treatment. If patients knew about Lumoral, they could treat themselves at home while waiting to see their dentist. In this way, they can reduce the risk of infection and caries and prevent tooth loss. I hope that all dentists will soon know about Lumoral. 

Huttunen points out that the ageing population also brings its own challenges in maintaining oral health. 

– Dental implants and other dentures place high demands on the patient's own ability to keep their teeth clean, and this becomes more challenging with ageing. Eating and smiling are basic requirements for life! Lumoral brings great help to many people.