New Study Explores the Efficacy of Photodynamic Therapy in Adolescents Undergoing Orthodontic Treatment

Lund, Sweden – A groundbreaking clinical study titled "Efficacy of Regular Home Use of Dual-Light Photodynamic Therapy on Oral Health in Adolescents Undergoing Fixed Orthodontic Treatment" is now underway at Borgska Villan's Specialist Dental Care clinic in Lund, Sweden. Known as the CleanBracket study, this research evaluates the effectiveness of the antibacterial Lumoral method in improving oral health for teenagers with fixed braces.

Led by Dr. Ann-Marie Roos Jansåker, Associate Professor at the Department of Periodontology, Malmö University, and former President of the Swedish Society of Periodontology and Implantology, in collaboration with Dr. Katja Elses, Specialist in Orthodontics, the study aims to determine if regular use of the light-activated Lumoral therapy can reduce plaque buildup and prevent common orthodontic issues such as gingival inflammation and caries.

"The study investigates how Lumoral's advanced technology can enhance oral health in adolescents with fixed braces, addressing the complexities of maintaining oral hygiene with orthodontic appliances," explains Clinical Project Manager Mikko Kylmänen from Koite Health Ltd, the company behind Lumoral. "We aim to provide robust data on whether this light-activated therapy can effectively mitigate these risks."

Approved by ethical committees in April 2023 and by Läkemedelsverket (the Swedish Medical Products Agency) in June 2023, the study began patient enrollment in November 2023. It involves 40 participants undergoing orthodontic treatment, randomized into either the Lumoral treatment group or a control group. Over 12 weeks, clinical measurements including visible plaque index (VPI), bleeding on probing (BOP), and orthodontic plaque index (OPI) will be assessed, alongside microbiological analyses to evaluate the effectiveness of the device.

The Clean-Bracket study focuses on adolescents aged 15 to 18, who are at higher risk of plaque buildup and gingival inflammation due to the challenges posed by fixed braces. The study will determine if light-activated antibacterial treatment can improve plaque control and manage oral health over time. The Lumoral device, developed by Finnish scientists, may also offer a photobiomodulation (PBM) effect, potentially benefiting periodontal tissue health.

Photobiomodulation is a noninvasive therapy using low-level lasers or LEDs to stimulate cellular function, promote healing, and reduce inflammation. In dentistry, PBM enhances tissue repair and regeneration, though its use has been limited until recently.

Dr. Roos Jansåker emphasizes the importance of addressing the risks associated with braces, including caries and gingivitis. "Maintaining oral hygiene with braces is challenging, and issues like plaque buildup and gingivitis can worsen over time. Effective antibacterial treatments like Lumoral may play a crucial role in mitigating these risks."

Lumoral, a CE-marked medical device, combines antibacterial blue and red light with a photosensitive Lumorinse mouth rinse to target and reduce harmful bacteria. If proven effective, Lumoral could become a valuable tool for enhancing oral hygiene in orthodontic patients. "We are eager to see the results of this study, which represents a significant step forward in orthodontic care for adolescents. Early findings are promising, and we hope to validate Lumoral as an essential tool for improving oral health outcomes," adds Kylmänen.

In Brief: The Clean-Bracket study

A total of 40 participants are enrolled in the randomized, controlled trial, split into two groups: 20 subjects receiving Lumoral treatment and 20 in the control group. All subjects must provide signed consent, with parental consent needed for minors.

The study protocol includes four essential visits as part of the participants' routine dental care: Pre-treatment visit – Screening with inclusion and exclusion criteria and informed consent.

Baseline visit – Baseline assessments, randomisation, and the start of the intervention, including professional cleaning of teeth and fixed braces attachment.

Follow-up visit – Scheduled at 12 weeks post-baseline.

Each visit, lasting between 45 - 60 minutes, ensures careful monitoring of participants' oral health and the efficacy of the treatment.

In line with rigorous clinical standards, investigator Ann-Marie Roos Jansåker is "blinded," meaning she is unaware of which group each study participant belongs to, ensuring unbiased assessments throughout the trial.

The last patient's visit is expected to take place in the autumn of 2024, and the trial's final results are anticipated in the early spring of 2025. Koite Health, a company that specialises in innovative oral health solutions, is sponsoring the study.

As orthodontic treatment in adolescents can complicate daily oral hygiene, the Clean-Bracket study could provide valuable insights into new approaches for maintaining oral health in this vulnerable group. If successful, the Lumoral method could become a vital tool in enhancing plaque control and reducing gum inflammation in patients with braces.

Koite Health

Koite Health is a Finnish health tech company whose innovation, Lumoral, based on dual light therapy, is recommended by the Finnish Association of Dental Hygienists (FADH) and has revolutionized preventive dental care throughout Europe and Asia. The company's expert team consists of experienced doctors and technology experts. Founders Sakari Nikinmaa, Juha Rantala and Tommi Pätilä founded Koite Health in September 2018 with the help of the Biodesign project and the commercialization project funded by Business Finland and Aalto University.

Lumoral, developed by the company, is a teeth-cleaning device used in addition to regular tooth brushing. The device is suitable for everyone but especially beneficial for those with cavities or gingivitis. Lumoral has been scientifically developed, and its antibacterial effect is well established. Lumoral is a class II medical and CE-approved device.

References:
1. Rodriguez Salazar DY, et al. A systematic review of trends in photobiomodulation in dentistry between 2018 and 2022. F1000Research. 2023 Dec 28;12:1415.
2. Dompe C, et al. Photobiomodulation-Underlying Mechanism and Clinical Applications. J Clin Med. 2020 Jun 3;9(6):1724.