NCT05278416

Regular Home Use of Dual-light Photodynamic Therapy in the Management of 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: 202 (actual)
• Sponsor: Koite Health Oy · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Accepted

Summary

The study is a single site, randomized clinical trial designed to determine the efficacy of the Lumoral treatment in periodontitis patients.

Detailed description

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. The device is used by swishing a mouth rinse, strongly adhering to dental plaque. The plaque-adhered photoactive mouth rinse can be activated by a simple use light applicator. The antibacterial efficacy far exceeds chlorhexidine, without side effects in long-term use. Preliminary results have shown a promising anti-inflammatory response in addition to plaque reduction. This early-stage study is designed to determine the efficacy of the Lumoral method in periodontitis patients. Improved supragingival plaque control can help to also sustain subgingival plaque management in the long term. In addition, the device might have a photobiomodulation effect on periodontal tissues.

Conditions

• Periodontitis

Interventions

Type	Name	Description
DEVICE	Lumoral treatment -device and Lumorinse tablets	Subjects will use Lumoral treatment -device and Lumorinse tablets daily as per protocol.

Timeline

• Start date: 2022-02-08
• Primary completion: 2025-04-14
• Completion: 2025-04-29
• First posted: 2022-03-14
• Last updated: 2026-01-22

Locations

1 site across 1 country: Finland