Actively Recruiting

Phase Not Applicable
Age: 20Years - 70Years
All Genders
NCT07278999

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

Led by Medical University of Silesia · Updated on 2026-04-30

60

Participants Needed

1

Research Sites

47 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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 blue as a photosensitizer activated by a 635 nm diode laser, and clobetasol used twice daily for thirty days. Clinical outcomes will be measured using lesion size, standardized scoring systems, and patient-reported scales for pain and swelling. Follow up at one week, one month, and three months will document healing progress and relapse rates. Safety monitoring includes evaluation for infections and adverse reactions. The expected outcome is to determine which therapy provides the most effective, safe, and durable improvement. The study may offer evidence supporting laser based methods as alternatives that avoid the risks associated with long term steroid use.

CONDITIONS

Official Title

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

Who Can Participate

Age: 20Years - 70Years
All Genders

Eligibility Criteria

Eligible

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.
Not Eligible

You will not qualify if you...

  • Have systemic diseases such as uncontrolled diabetes (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 blood 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.
  • Received vaccinations within the past 6 months.
  • Use medications known to trigger lichenoid reactions, including antihypertensives, oral antidiabetics, metal-containing compounds, NSAIDs, or certain antibiotics/chemotherapeutics.
  • Are pregnant or breastfeeding, including up to 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.
  • Lack consent to participate.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Department of Periodontology and Oral Mucosa Diseases

Zabrze, Silesian Voivodeship, Poland, 41-800

Actively Recruiting

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Research Team

J

Jakub Fiegler-Rudol, PhD candidate

CONTACT

R

Rafał Wiench, Professor, DMD, PhD

CONTACT

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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