The importance of research

Clinical device research is essential to ensure that healthcare devices are safe, effective, and meet the necessary performance standards. High-quality clinical trials, grounded in scientific evaluation, provide both users and healthcare professionals with confidence in the safety, reliability, and effectiveness of medical devices.

Standards are the foundation of clinical research

International standards are the cornerstones of the clinical study 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 clinical trial for Lumoral should have clear goals and objectives, either to confirm that the treatment's effects align with the already approved marketing authorization or to explore new uses for Lumoral. Strict regulatory compliance will ensure that the safety of participants in the studies is maintained.

Driving innovation

Lumoral's research opens up new possibilities for the development of oral care. Our company is proud to be able to promote health and well-being through innovative solutions.

Ongoing and completed studies highlight the diverse applications of Lumoral in enhancing oral health across various populations and conditions.

Lumoral® Zero Plaque Program

Lumoral® is a patented medical device from Finland

Could Lumoral solve your patient's problem?

Lumoral for Periodontitis

Periodontitis is a disease of the gingival attachment tissues that develops from gingivitis. A critical factor that leads to periodontitis is plaque, which forms on the tooth surface as residual plaque hardens due to minerals in saliva. Tartar buildup always causes gingivitis.

Lumoral is used to prevent tartar buildup, especially in areas of the mouth that are difficult to clean but easily accumulate tartar such as molars and dental prostheses. Lumoral treats periodontitis by eliminating plaque and by reducing gingival bleeding, and the number of deepened gingival pockets (Pakarinen et al. 2022). 

Lumoral for Implant health

One dental implant is lost every four minutes around the world. Implant diseases include peri-implant mucositis and peri-implantitis. These are inflammatory conditions of the attachment tissues. Implants must be treated carefully, perhaps even more carefully than natural teeth. Implant threads are a very good retention site for biofilm bacteria, as they are difficult to clean even by professionals.

The need to prevent bacterial problems and tartar buildup is, therefore, highly importantwhen aiming for a long implant life. Lumoral helps eliminate biofilm before it hardens into tartar, making it easier to keep the artificial root clean.

Lumoral for Halitosis

Poor oral hygiene is the most common cause of halitosis, or bad breath. Mechanical cleaning does not reach all the odor-producing bacterial masses, so the mouth can smell bad even if good oral hygiene is maintained.

Using Lumoral eliminates foul-smelling bacteria from areas where the cleaning equipment could not reach. The tongue also often collects a lot of bacterial mass, which is difficult to remove because of the bacteria's attachment to the tongue's surface. Lumoral treatment eliminates the bacteria, and the tongue becomes cleaner compared to active mechanical tongue cleaning.

Lumoral for Gingivitis

5% of all oral diseases are caused by bacteria, and most of them could be prevented if gingivitis could be cured early. Lumoral is a light-activated solution for oral health. It is the state-of-the-art treatment for managing bacterial plaque, while supporting oral flora.

Lumoral effectively treats gingivitis by affecting plaque volume and gum bleeding (Pakarinen et al. 2022).

Lumoral for Caries

Lumoral treatment is based on a unique combination of double light, a reaction that produces reactive oxygen. An enzyme called catalase defends against reactive oxygen, and streptococcal bacteria lack this enzyme.

Streptococcus mutans is one of the most important caries-causing bacteria. The mutans bacterium forms a protective layer on the surface of the biofilm, so when we target mutans with Lumoral, we are also acting on the biofilm as a whole.

Lumoral for Orthodontics

Sometimes orthodontic treatment must be discontinued if teeth are at risk of decay. Lumoral removes biofilm from areas that cannot be reached effectively by mechanical cleaning alone.

Lumoral reduces the risk of caries, halitosis, and gum disease and it facilitates mechanical cleaning. Bacteria are more easily eliminated from the mouth once they are dead.

A summary of study results

"A clinical trial is not just a single marathon; it is a series of marathons run repeatedly in slightly different landscapes. Even if you achieve one goal, there may be several journeys still ahead, along with new ones yet to come." - Mikko Kylmänen, Research Officer, Koite Health Ltd

In research cooperation with