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Photobiomodulation, Photodynamic Therapy, and Clobetasol in the Treatment of Oral Lichen Planus.

RecruitingNAAges 20 Years - 70 YearsAllMedical University of Silesia
NCT07278999 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

This study aims to compare three treatment approaches for the erosive form of oral lichen planus, a chronic inflammatory condition that often causes pain, impaired oral function, and frequent relapses. Sixty adults with a confirmed diagnosis will be randomly assigned to photobiomodulation, Photodynamic Therapy, or topical clobetasol, which serves as the current standard of care. The project investigates how effectively each method promotes healing of erosive lesions, reduces pain, improves oral functions such as chewing and swallowing, and prevents recurrence after treatment. Before enrollment, participants will undergo microbiological testing, tissue autofluorescence assessment, and histopathological confirmation. Treatment will follow strict protocols tailored to each therapy type, with PBM applied twice weekly, PDT administered once weekly for six consecutive weeks using toluidine blu

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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 OLP within the past 3 months. * Provide written informed consent. Exclusion Criteria: * Systemic diseases or conditions such as uncontrolled diabetes (random glucose ≥200 mg/dl), cardiovascular failure, or a pacemaker. * Autoimmune/connective tissue diseases such as lupus with positive ANA testing. * Current or past cancer, graft-versus-host disease, or hematologic disorders (anemia, leukemia, lymphoma, bleeding disorders, hemophilia, von Willebrand disease). * Enzymatic or metabolic disorders such as G6PD deficiency (favism) or porphyria. * Viral hepatitis A, B, or C. * Recent vaccinations (within the past 6 months). * Use of medications known to trigger lichenoid reactions, including: * Antihypertensives (beta-blockers, diuretics, ACE inhibitors, centrally acting agents). * Oral antidiabetics (sulfonylureas). * Metal-containing compounds (lithium, gold, arsenic, mercury). * NSAIDs (e.g., ibuprofen). * Antibiotics/chemotherapeutics (tetracyclines, sulfonamides). * Pregnancy or breastfeeding (including up to 6 months post-lactation). * Photosensitivity to UV light. * Smoking more than 5 cigarettes per day. * Lesions located adjacent to amalgam fillings or metal prosthetic restorations. * Any degree of dysplasia on histopathology. * Treatment for OLP within the last 3 months. * Active oral fungal or bacterial infection at screening. * Lack of consent to participate.
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What it tests

  • Photobiomodulation using 635 nm diode laser
  • Photodynamic therapy - laser mucosal treatment
  • Clobetasol propionate 0.05 percent topical application
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Where

1 site
Department of Periodontology and Oral Mucosa Diseases
Zabrze, Poland
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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