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Treatment of Periodontitis in Smoking Patients with the Lumoral Method

Treatment of Periodontitis in Smoking Patients with the Lumoral Method

(This article is based on the writing of dentist Viktoria Ljutkina, published in the largest dental medicine periodical in Estonia, Ajakiri Hambaarst. Ljutkina works as a dentist at Läänemere Hambakliinikus dental clinic in Tallinn.)

Periodontitis is a common disease affecting an estimated 20–50% of the population. This severe oral condition originates in the gum tissue, and if left untreated, the inflammatory process spreads deeper, leading to tooth loss (1). Periodontitis is a multifactorial disease primarily caused by bacterial colonization in the oral cavity (2). Many risk factors, such as diabetes and smoking, contribute to the development of periodontitis and influence its prognosis.

The goal of periodontitis treatment is to eliminate factors promoting inflammation in the oral cavity and support the patient's immune system. Fundamental to gum disease treatment is meticulous oral hygiene, preventing the formation of new dental calculus and reducing the number of bacteria in the oral cavity, thereby promoting periodontitis healing (3). The effects of Antimicrobial Photodynamic Therapy (aPDT) on oral diseases, including periodontitis and peri-implantitis, have been extensively studied, with substantial clinical evidence supporting its effectiveness.

The Lumoral oral care method, developed by Finnish scientists, is based on dual-light antibacterial therapy that can be administered at home. Lumoral's effects have been scientifically proven in various clinical studies. Regular use of Lumoral prevents tooth decay and significantly reduces the count of periodontal bacteria in the mouth (4).

Lumoral treatment relies on the administration of dual-light therapy through the Lumoral oral device – near-infrared light and antibacterial blue light. The near-infrared light has a wavelength of 810 nm, penetrating tissues up to 10 cm deep. Antibacterial blue light, with a wavelength of 410 nm, acts on inflammation-causing bacteria, slowing down their growth. When porphyrin molecules in the bacteria are exposed to specific wavelengths of light, they produce reactive oxygen species, which, in turn, kill the bacteria.

Lumoral is effective against harmful bacteria in the mouth

The Lumoral method includes a light source and a mouthwash. The photosensitive indocyanine green molecule in the Lumorinse mouthwash, in combination with the light source, achieves the desired therapeutic outcome. Indocyanine green (ICG) is water-soluble and highly light-absorbing. The dual light reacts with the ICG photosensitizer, generating reactive oxygen species (ROS) and heat, initiating a series of photochemical and biological processes that destroy the bacterial cell membrane, thereby damaging the bacterial cell structure.

The body's immune cells use a similar method to protect against harmful pathogens. Pathogenic bacteria contain porphyrin and flavin molecules with photosensitive properties. Therefore, Lumoral mainly affects pathogenic bacteria.

The Lumoral method has proven to be highly effective against harmful bacteria, with no development of bacterial resistance even with repeated use (5). The largest European study on periodontitis demonstrates significant improvement in treatment outcomes when dental calculus is regularly removed from the mouth. Lumoral has been shown to help users achieve better oral hygiene, even after using the most modern and efficient electric toothbrushes, which can leave plaque on teeth. The study also indicates that Lumoral aids in achieving better oral hygiene.

In support of brushing and flossing

Lumoral does not replace the need for mechanical brushing and cleaning between teeth but helps further improve oral hygiene. Effectively, Lumoral can remove bacteria from the surfaces of teeth and even from the gumline, where access with a toothbrush may be challenging.

aPDT treatment has proven to be significantly more effective and better tolerated than commonly used chlorhexidine mouthwashes. Home use of Lumoral reduces gum inflammation and enhances oral hygiene. Effective oral hygiene also enhances the efficiency of periodontal treatment (6).

Periodontal treatment and improvement of oral hygiene are considered the gold standard in periodontitis treatment. However, some patients may not respond positively to treatment due to risk factors and/or systemic diseases.

Smoking is considered a major risk factor for gum diseases, negatively impacting both the course of the disease and treatment outcomes. Nicotine in tobacco products hinders the oral cavity's defense mechanisms, impedes the healing of periodontal tissues, and adversely affects tissue blood circulation. Changes in the oral microbiome also occur due to smoking, promoting the development of advanced periodontitis and poorer healing after treatment. Finding effective treatment for smoking patients with periodontitis is crucial because managing periodontitis based on the aforementioned biological processes poses a significant challenge for physicians (7).

Independent Lumoral study shows efficacy

I decided to try the Lumoral method at Läänemere Hambakliinikus dental clinic to improve oral hygiene in patients with periodontitis. Twelve smoking patients with generalized periodontitis at stage III, grade B, and without other chronic diseases were selected for the clinical study. Half of the patients received Lumoral photodynamic therapy 2–3 times a week for six months (recommended dose after periodontal treatment twice daily for four weeks). The remaining patients received traditional periodontal treatment only. The general treatment strategy was similar for all patients, including comprehensive diagnostics (periodontal condition, radiological diagnostics, anamnesis), non-surgical periodontal treatment, and periodontal follow-ups at two weeks, three months, and six months. During the control visits, patients' dental calculus was stained to check oral hygiene.

I noticed that patients using Lumoral in addition to traditional treatment showed better results in periodontal treatment outcomes (pocket depths, tooth mobility, BOP, VIP, SUP) and oral hygiene compared to those not using Lumoral as an oral hygiene aid. Based on my clinical experience, we can conclude that using the Lumoral method improves patients' oral hygiene and leads to more positive treatment outcomes. It is essential to use the device correctly and regularly following the dentist's recommendations.

 

 

References:

Petersen, P. E., Baehni, P. C. Periodontal health and global public health. Periodontol 2000. 2012 Oct; 60 (1): 7–14.

Bartold, P. M., Van Dyke, T. E. Periodontitis: a host-mediated disruption of microbial homeostasis. Unlearning learned concepts. Periodontol 2000. 2013 Jun; 62 (1): 203–17.

Greenstein, G. Research, Science and Therapy Committee of the American Academy of Periodontology. The Role of supra- and subgingival irrigation in the treatment of periodontal diseases. J Periodontol. 2005; 76: 2015–27.

Villafuerte, K. R., Martinez, C. J. H., Vieira, L. H. P., Nobre, A. V. Benefits of antimicrobial photodynamic therapy as an adjunct to non-surgical periodontal treatment in smokers with periodontitis: a systematic review and meta-analysis. Medicina 2023, 59 (4): 684.

Lähteenmäki, H., Pätilä, T., Räisänen, I. T., Kankuri, E., Tervahartiala, T., Sorsa, T. Repeated Homeapplied dual-light antibacterial photodynamis therapy can reduce

Antibacterial Dual-Light Therapy: A Novel and Effective Approach to Managing Oral Mucositis

Antibacterial Dual-Light Therapy: A Novel and Effective Approach to Managing Oral Mucositis

Jessica Hentilä, a student at the Faculty of Medicine, University of Helsinki, conducted in-depth research on oral mucositis and its treatment. Oral mucositis is an inflammatory condition of the oral mucosa that arises from cancer treatments such as chemotherapy and radiation therapy, commonly affecting cancer patients as a side effect.

The symptoms of oral mucositis include swelling, redness, and painful ulcers on the oral mucosa, leading to difficulties in eating, interruptions in treatments, and even severe consequences such as sepsis and death. Traditional prevention and symptomatic treatment are commonly employed, but Hentilä's research suggests that antibacterial dual-light therapy provides a new and effective approach to managing oral mucositis.

Hentilä's bachelor's thesis, titled "Oral Mucositis – Antibacterial Dual-Light Therapy in the Treatment of Oral Mucositis," focused specifically on the use of antibacterial light in treating oral mucositis. The research explored antibacterial photodynamic therapy (aPDT) and antibacterial blue light (aBL), as well as their combination – known as dual-light therapy. 

The study investigated the efficacy of dual-light therapy against Streptococcus Oralis (S. Oralis), a type of bacteria present in the oral microbiome. The results indicated that dual-light therapy could eliminate all bacterial colonies, regardless of the relative light energies of aPDT and aBL.

Addressing Side Effects of Cancer Treatments

In Finland, one in three individuals develops cancer during their lifetime, making the study of treatment side effects, particularly oral mucositis, crucial. According to the research, oral mucositis adversely affects many cancer patients, impacting their overall quality of life. Traditional treatments, such as ice therapy and maintaining oral hygiene with traditional means, may not always provide sufficient benefits, necessitating the exploration of new therapeutic approaches.

The study emphasizes that maintaining oral hygiene remains a crucial aspect of oral mucositis treatment, and light therapy devices could play a permanent role in oral healthcare. While reducing the significance of oral mucositis in the long term is an overarching goal, research on antibacterial dual-light therapy devices offers promising prospects for the advancement of oral healthcare.

Source:

Hentilä, Jessica. "Oral Mucositis – Antibacterial Dual-Light Therapy in the Treatment of Oral Mucositis." Bachelor of Medicine, Faculty of Medicine, University of Helsinki, October 22, 2023."



Lumoral's journey from a brilliant idea to a unique oral health medical device

Lumoral's journey from a brilliant idea to a unique oral health medical device

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.