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
The largest periodontal study in Europe shows that periodontal treatment outcomes improve significantly when daily Lumoral treatment is added to the routine of periodontal home care.
In 54% of Lumoral users, the gingival inflammation index (BOP), an indicator of inflammation, was reduced to healthy levels (BOP less than 10%). Two out of three (67%) patients treated with Lumoral had at least half the number of deep gingival pockets compared to baseline. This result was significantly better than in the control group. Four patients in the Lumoral group had no deep gingival pockets at the end of the period.
The study found consistent findings and clear differences between the groups. In subjects of the Lumoral group, a reduction in plaque, a reduction in gum bleeding, and a reduction in gingival pockets were observed.
The study found that light-activated Lumoral treatment improves oral health in 24-hour care home residents as part of a regular oral hygiene routine. The Lumoral group had better oral hygiene as well as better oral moisture (objectively and subjectively assessed).
In 2022, Hanna Lähteenmäki, a Lumoral researcher and President of the Finnish Association of Dental Hygienists, published the results of a pilot study showing that Lumoral treatment has also shown promising results in the treatment of dental implant-related infections. According to Lähteenmäki, the amount of plaque and gum bleeding in patients were significantly reduced compared to baseline, and there were no side effects associated with Lumoral. In this study, the effect of Lumoral on the inflammatory marker aMMP-8, which indicates periodontal disease, has been of interest.
A case report on a 78-year-old male patient with vascular dementia found that Lumoral antibacterial treatment was effective in eliminating harmful oral bacteria while also treating advanced gum disease. Recovery from severe periodontal disease over a 13-month follow-up period was excellent, the study reveals. Oral hygiene improved markedly and the number of infected gum pockets decreased significantly. In addition, clinical adherence improved. Only one infected periodontal pocket remained. This can be argued to be at least partly due to occlusal trauma, the researchers point out.
A plaque study carried out by students of oral hygiene at the Metropolia University of Applied Sciences, in Helsinki, found that using Lumoral twice a week is also beneficial for people in good health. The study also revealed that biofilm reduction was significantly greater in the experimental group of Lumoral users than in the control group.
The aim of the study was to investigate the effectiveness of the antimicrobial Lumoral method in reducing oral biofilm as part of oral self-care in healthy volunteers aged 18-70 years.
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