NCT05401201

Dual-light Antibacterial Photodynamic Therapy as an Adjunctive Treatment to Corticosteroid Treatment in OLP

Dual-light Antibacterial Photodynamic Therapy as an Adjunctive Treatment to Topical Corticosteroid Treatment in Patients With Gingival Involvement of Oral Lichen Planus - a Randomized Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Koite Health Oy · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

This study is designed to investigate the effectiveness of plaque control intervention by home-use dual-light aPDT Lumoral -device as an adjunctive or alternative treatment to triamcinolone acetonide (TCA) mouth rinse or other topical corticosteroid treatment on the symptoms and clinical appearance of symptomatic gingival involvement of oral lichen planus (OLP).

Detailed description

Oral Lichen Planus (OLP) is a relatively common, chronic immune-mediated mucocutaneous disease,that usually occurs on the oral mucosa surfaces. Oral lesions are commonly multiple with a bilateral and symmetrical localization. Most affected sites in the oral cavity are the buccal and lingual mucosa, and the gingiva. Approximately 10% of patients with OLP present manifestations in the gingiva. 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 (aPDT). 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. Use of the device can improve supragingival plaque control. Preliminary results have shown a promising anti-inflammatory response in addition to plaque reduction. A total of 60 subjects with histologically confirmed diagnosis of OLP with gingival involvement are enrolled to the study. The subjects are randomized to a study group and a control group. Both groups will use topical corticosteroid treatment for two weeks. In addition, the study group will use Lumoral-device initially once a day. All the subjects shall be assessed for desquamative gingivitis clinical score (DGCS), Escudier Index (EI), visible plaque index (VPI), bleeding on probing index (BOP), pain score (VAS), aMMP-8 inflammation marker and oral candidosis. These analyses shall be performed at baseline and at 4 week, 3, 6 and 12 months after the treatment started. In addition, psychosocial factors shall be assessed by the graded chronic pain scale (GCPS), the oral health impact profile (OHIP-14) and the generalized anxiety disorder (GAD-7) questionnaires at baseline and at 6 and 12 months after the treatment initiation. Primary outcome is improvement in average Pain score (VAS) symptom diary during the 12 month study period.

Conditions

• Oral Lichen Planus
• Dental Plaque
• Oral Bacterial Infection

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: 2023-02-24
• Primary completion: 2026-04-01
• Completion: 2026-04-13
• First posted: 2022-06-02
• Last updated: 2026-04-17

Locations

2 sites across 1 country: Finland