Actively Recruiting
Effectiveness of Photobiomodulation, Photodynamic Therapy, and Clobetasol in the Treatment of the Erosive Form of Oral Lichen Planus - a Randomized Clinical Trial.
Led by Medical University of Silesia · Updated on 2026-04-30
60
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating three treatment methods for the erosive form of oral lichen planus, a chronic inflammatory condition that causes pain, affects oral functions like chewing and swallowing, and often relapses. This trial compares photobiomodulation, Photodynamic Therapy (PDT), and topical clobetasol to understand which method best promotes healing, reduces symptoms, and prevents recurrence. The study involves adults diagnosed through biopsy and uses advanced imaging and microbiological tests to confirm disease type before starting treatment. Participants are randomly assigned to one of three groups. The photobiomodulation group receives low-level laser treatment twice weekly for up to eight sessions to stimulate tissue repair. The PDT group uses a photosensitizing gel activated by a laser once weekly for six weeks to target affected tissue. The clobetasol group applies a corticosteroid ointment twice daily for thirty days as standard care. Each treatment follows strict protocols to ensure safety and consistency. During the study, patients will have their lesions measured and scored, pain assessed with validated scales, and photographs taken to track changes. Follow-up visits occur one week, one month, and three months after treatment to monitor healing and relapse. Researchers will also check for infections and side effects throughout. The main outcomes are lesion severity, treatment response, and pain improvement, helping to determine the safest and most effective approach for managing erosive oral lichen planus.
CONDITIONS
Brief Title
Photobiomodulation, Photodynamic Therapy, and Clobetasol in the Treatment of Oral Lichen Planus.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Be between 20 and 70 years old.
- Have histologically confirmed erosive or ulcerative oral lichen planus based on a biopsy.
- Have no active aerobic bacterial infection or oral fungal infection.
- Have had no treatment for oral lichen planus within the past 3 months.
- Provide written informed consent.
You will not qualify if you...
- Have systemic diseases such as uncontrolled diabetes (random glucose 60 mg/dl), cardiovascular failure, or a pacemaker.
- Have autoimmune or connective tissue diseases like lupus with positive ANA testing.
- Have current or past cancer, graft-versus-host disease, or hematologic disorders including anemia, leukemia, lymphoma, bleeding disorders, hemophilia, or von Willebrand disease.
- Have enzymatic or metabolic disorders such as G6PD deficiency or porphyria.
- Have viral hepatitis A, B, or C.
- Have received recent vaccinations within the past 6 months.
- Use medications known to trigger lichenoid reactions such as certain antihypertensives, oral antidiabetics, metal-containing compounds, NSAIDs, antibiotics, or chemotherapeutics.
- Are pregnant, breastfeeding, or within 6 months post-lactation.
- Have photosensitivity to UV light.
- Smoke more than 5 cigarettes per day.
- Have lesions next to amalgam fillings or metal prosthetic restorations.
- Have any degree of dysplasia on histopathology.
- Have active oral fungal or bacterial infection at screening.
- Do not consent to participate.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 4 to 5 weeks depending on treatment arm
Participants receive one of three treatments: photobiomodulation with a 635 nm diode laser performed twice weekly for up to eight sessions until complete healing; photodynamic therapy using toluidine blue activated by a 635 nm diode laser once weekly for six sessions; or topical clobetasol propionate applied twice daily for thirty days. This stage aims to reduce lesion severity, pain, and promote mucosal healing.
Twice weekly visits for up to 4 weeks or weekly visits for 6 weeks or daily self-application for 30 days depending on treatment assignment
Duration - 3 months
After treatment completion, participants attend follow-up visits to assess the durability of mucosal healing, monitor lesion size, pain, swelling, and clinical grade, and evaluate microbiological status to detect changes in oral mucosa colonization. Safety monitoring for adverse reactions continues during this period.
Visits at 1 week, 1 month, and 3 months after treatment completion
Trial Site Locations
Total: 1 location
1
Department of Periodontology and Oral Mucosa Diseases
Zabrze, Silesian Voivodeship, Poland, 41-800
Actively Recruiting
Research Team
J
Jakub Fiegler-Rudol, PhD candidate
R
Rafał Wiench, Professor, DMD, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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