A clinical study titled ‘Efficacy of Regular Home Use of Dual-Light Photodynamic Therapy on Oral Health in Adolescents Undergoing Fixed Orthodontic Treatment’ is currently underway at Borgska Villan’s Specialist Dental Care clinic in Lund, Sweden.
According to news shared by Koite Health, the research is also known as the “Clean-Bracket study” and aims to evaluate 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 at Malmö University and former President of the Swedish Society of Periodontology and Implantology, in collaboration with Dr Katja Elses, a specialist in orthodontics, the study seeks to determine if regular use of 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,” explained clinical project manager Mikko Kylmänen from Koite Health, 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, who are randomised into either the Lumoral treatment group or a control group. Over a period of 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 15-18, a group at higher risk of plaque buildup and gingival inflammation due to the challenges posed by fixed braces. The study aims to 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.
PBM is a non-invasive 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 emphasised 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,” added Kylmänen.
The last patient’s visit is expected to take place in the autumn of 2024, and the trial’s results are anticipated in the early spring of 2025.
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