NCT06017817

Antibacterial Photodynamic Therapy in the Management of Peri-implantitis

Regular Home-use of Antibacterial Photodynamic Therapy in the Management of Peri-implantitis

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Nilminie Rathnayake · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

This early-stage study is designed to determine the efficacy of the Lumoral method in periimplantitis. 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, thus impacting osseointegration.

Detailed description

Clinical signs of inflammation in peri-implantitis include bleeding on probing, suppuration, increased probing depth, and radiographic signs of bone loss. Currently, the best treatment options for peri-implantitis include non-surgical methods of biofilm removal in the supra-mucosal area around implants, and comprehensive guidance on self-performed infection control procedures. With more advanced peri-implantitis, anti-infective surgical treatment protocol would be needed. Matrix metalloproteinase 8 (MMP-8) has been found to be elevated in association with oral infections, such as periodontitis and peri-implantitis. The level of active MMP-8 (aMMP-8) can detect to determine tissue health and to assess inflammation, and can easily be measured during a regular dental appointment with a chairside test. 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 method mechanism of action is antibacterial photodynamic therapy (aPDT). The method 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. Preliminary results have shown a promising anti-inflammatory response in addition to plaque reduction.

Conditions

• Peri-Implantitis
• Plaque, Dental

Interventions

Type	Name	Description
DEVICE	Lumoral Treatment	Anti-infective photodynamic therapy for plaque-induced oral conditions
PROCEDURE	Standard oral hygiene instructions	Standard oral hygiene instructions for electric toothbrushing, interdental brush, and dental floss use
PROCEDURE	Scaling and root planing (SRP	non-surgical anti-infective treatment by scaling and root planing
PROCEDURE	surgical anti-infective peri-implantitis treatment	surgical anti-infective peri-implantitis treatment

Timeline

• Start date: 2024-05-13
• Primary completion: 2025-03-31
• Completion: 2026-12-31
• First posted: 2023-08-30
• Last updated: 2024-10-18

Locations

1 site across 1 country: Sweden