NCT05698823

Regular Home-use of Dual-light Photodynamic Therapy in the Management of Chronic Stage III-IV Periodontitis

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: Koite Health Oy · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

This study is designed to determine the efficacy of the Lumoral method in chronic periodontitis with a targeted group of stage III and IV periodontitis. Improved supragingival plaque control can help to also sustain the subgingival plaque management in the long term. In addition, the method might have a photobiomodulation effect on periodontal tissues.

Detailed description

The Lumoral Treatment 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 (aPDT). The device is used by swishing a specially designed mouth rinse that strongly adheres to dental plaque. The plaque-adhered photoactive mouth rinse can be activated by a simple-to-use light applicator. Preliminary results have shown promising anti-inflammatory responses in addition to plaque reduction.

Conditions

• Periodontitis Chronic Generalized Moderate
• Periodontitis Chronic Generalized Severe

Interventions

Type	Name	Description
DEVICE	Lumoral Treatment	The Lumoral treatment -device is a CE-marked antibacterial home-use device for the treatment and prevention of oral diseases caused by bacteria. It is used in combination with a CE-marked mouth rinse called Lumorinse.

Timeline

• Start date: 2023-06-06
• Primary completion: 2025-12-12
• Completion: 2026-01-12
• First posted: 2023-01-26
• Last updated: 2026-03-19

Locations

1 site across 1 country: Lithuania