Using a dual-light device to treat oral lichen planus alongside corticosteroids
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
This study is testing if using a special light device along with a corticosteroid mouth rinse can help people with oral lichen planus improve their oral health and reduce inflammation.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Koite Health Oy Industry-sponsored |
| Locations | 2 sites (Tampere, Pirkanmaa and 1 other locations) |
| Trial ID | NCT05401201 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of a home-use dual-light antibacterial photodynamic therapy device, Lumoral, as an adjunctive treatment to corticosteroid mouth rinse for patients with oral lichen planus (OLP) exhibiting gingival involvement. The trial involves 60 subjects who will be randomized into two groups: one receiving standard corticosteroid treatment and the other receiving both corticosteroids and Lumoral treatment. The study aims to assess various clinical outcomes, including plaque control and inflammation reduction, over a two-week period. The device works by activating a photoactive mouth rinse that targets dental plaque, potentially improving oral health in OLP patients.
Who should consider this trial
Good fit: Ideal candidates are individuals with a histologically confirmed diagnosis of oral lichen planus with bilateral symmetrical lesions and gingival involvement.
Not a fit: Patients with lichenoid lesions induced by contact allergy or drugs, or those who have received recent treatment for OLP, may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a novel and effective approach to managing symptoms of oral lichen planus and improving oral hygiene.
How similar studies have performed: Preliminary results from similar studies using antibacterial photodynamic therapy have shown promising outcomes, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Histologically confirmed diagnosis of OLP with bilateral symmetrical lesions and gingival involvement * Able to provide a written consent * Willing and able to complete questionnaires * Able to co-operate with the treatment protocol and avoid any other oral hygiene measures outside of the study protocol Exclusion Criteria: * Lichenoid lesions suspected to be induced by contact allergy or drugs * Any treatment for OLP in two weeks prior to the study/ a history of topical therapy for OLP in the past 2 weeks or systemic therapy in the past 4 weeks; * Pregnant or lactating * Photosensitivity * Use of antibiotics within 2 weeks prior the study
Where this trial is running
Tampere, Pirkanmaa and 1 other locations
- Tampere University Hospital, Oral and maxillofacial diseases — Tampere, Pirkanmaa, Finland (Not_yet_recruiting)
- Wellbeing services County Pirkanmaa, Health Services, Orthodontics and specialized dental care — Tampere, Pirkanmaa, Finland (Recruiting)
Study contacts
- Study coordinator: Mikko Kylmänen
- Email: mikko.kylmanen@koitehealth.com
- Phone: +358407245934
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.