NCT05425784

Home Use of Dual-light Photodynamic Therapy for Chronic Periodontitis

Regular Home Use of Dual-light Photodynamic Therapy in the Management of Chronic Periodontitis

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: Koite Health Oy · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

This early-stage research is designed to determine the efficacy of the Lumoral method in chronic periodontitis patients. Improved supragingival plaque control can help to also sustain the subgingival plaque management in the long term. In addition, the device might have a photobiomodulation effect on periodontal tissues.

Detailed description

Periodontitis is a chronic inflammatory disease leading to a progressive loss of the tooth-supporting apparatus. The disease is strongly associated with deranged biodiversity patterns in dental plaque. The Lumoral is a CE-marked medical device developed to provide a potent, targeted antibacterial action on dental plaque in a home environment. The device mechanism of action is antibacterial photodynamic therapy. The device is used by swishing a mouth rinse, which has a strong adherence to dental plaque. The plaque-adhered photoactive mouth rinse can be activated by a simple to use light applicator. The antibacterial efficacy far exceeds chlorhexidine, without side effects in a longterm use. Preliminary results have shown a promising anti-inflammatory response in addition to plaque reduction. Ninety (90) stage I-III periodontitis patients are randomized to Lumoral treatment group or control group. Both groups shall receive mechanical plaque control by scaling and root planning (SRP) and standard oral hygiene instructions for electric toothbrush, interdental brush, and dental floss use. All the patients shall be assessed for the clinical periodontitis status. These assessment and analyses shall be performed at baseline, at 3 months and at 6 months after the treatment.

Conditions

• Periodontal Diseases
• Periodontitis
• Plaque, Dental
• Plaque Induced Gingivitis

Interventions

Type	Name	Description
DEVICE	Lumoral treatment	The investigational Lumoral treatment -device provides a constant and repeatable application which can be done at home and is easily available. All subjects in the study group will receive their own Lumoral treatment -device and Lumorinse-mouth rinse tablets for the complete duration of the study.
OTHER	Standard oral hygiene self care	Both groups shall be given oral and written instructions for twice-daily standard oral hygiene self-care.

Timeline

• Start date: 2023-01-19
• Primary completion: 2024-04-29
• Completion: 2025-01-13
• First posted: 2022-06-21
• Last updated: 2025-02-18

Locations

3 sites across 1 country: Finland