Photobiomodulation, Photodynamic Therapy, and Clobetasol in the Treatment of Oral Lichen Planus.
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-70
SponsorMedical University of Silesia
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Photobiomodulation using 635 nm diode laser
DevicePhotobiomodulation is delivered with a 635 nm diode laser in continuous mode at 100 mW, fluence 4 J/cm², and power density 0.2 W/cm². Each point is irradiated for 15 seconds using a noncontact technique with an 8 mm flat glass fiber tip and a 0.5 cm² spot size. Treatment points are spaced 2-3 mm apart over the lesion surface. Sessions are performed twice weekly until complete epithelial healing or for a maximum of eight sessions. This intervention aims to modulate inflammation and support mucosal repair in erosive oral lichen planus.
Photodynamic therapy - laser mucosal treatment
DevicePhotodynamic Therapy is performed using toluidine blue gel as a photosensitizer, applied to the affected mucosal surface under an occlusive dressing for ten minutes. Following removal of the dressing and excess photosensitizer, irradiation is carried out using a 635 nm diode laser (Smart M®, Lasotronix) operating in continuous-wave mode at an output power of 400 mW and a power density of 0.8 W/cm². A flat glass fiber tip of 8 mm diameter is used in a noncontact mode at a distance of approximately 1 mm from the lesion surface. Irradiation is applied point by point at a fluence of 120 J/cm² per point, with the duration of each point irradiation set at 2 minutes and 32 seconds; the total number of points and overall session duration are determined by lesion extent. Following irradiation, the photosensitizer is left in place for an additional three minutes before removal by oral rinsing with water. Sessions are conducted once weekly for six consecutive treatments. This intervention evaluat
Clobetasol propionate 0.05 percent topical application
DrugParticipants apply clobetasol propionate 0.05 percent directly to clean, dry oral mucosa twice daily for thirty days. The medication is used according to standard clinical practice for erosive oral lichen planus. The formulation serves as the active comparator to evaluate how laser-based treatments perform relative to conventional corticosteroid therapy. Participants are instructed to avoid eating, drinking, or rinsing for at least 30 minutes after application to ensure adequate mucosal contact.
Treatment groups
60 Participants
are divided into 3 treatment groupsGroup A: Photobiomodulation (PBM)Experimental treatment 1 intervention
Group B: Photodynamic Laser Therapy - TBO mediatedExperimental treatment 1 intervention
Group C: Topical Clobetasol 0.05 percentExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in erosive oral lichen planus lesion severity using the REA score
Lesion severity will be measured using the REA scoring system, which evaluates the reticular (R), atrophic (A), and erosive (E) components of oral lichen planus. Each component is quantified from standardized lesion tracings and clinical measurements taken during oral examinations. Scores are calculated according to the protocol formula: REA = (R × 1) + (A × 1.5) + (E × 2). The change in total REA score from baseline reflects the therapeutic effect of each intervention on healing of erosive lesions.
Time frame
Baseline to 1 week after completion of assigned treatment2
Efficacy Index (EI) for overall treatment response
The Efficacy Index (EI) quantifies overall clinical improvement using the formula defined in the study protocol: EI = \[(total REA score before treatment - total REA score after treatment) ÷ total REA score before treatment\] × 100 percent. EI will be used to categorize outcomes as complete healing, significant improvement, moderate improvement, mild improvement, or no improvement.
Time frame
Baseline to 1 week after completion of assigned treatment3
Improvement in pain intensity (NB)
NB represents the percentage improvement in pain based on the Visual Analogue Scale (VAS). It is calculated using the formula: NB = \[(VAS before treatment - VAS after treatment) ÷ VAS before treatment\] × 100 percent. NB will classify improvement as complete, significant, moderate, mild, or absent.
Time frame
Baseline to 1 week after completion of assigned treatmentSecondary outcomes
1
Change in lesion size measured in mm²
Lesion surface area will be measured using transparent millimeter-grid foil applied to the mucosal surface. Boundaries of each lesion will be traced and the total area calculated. Changes from baseline will be compared across treatment groups.
Time frame
Baseline, 1 week, 1 month, and 3 months after treatment completion2
Change in pain intensity using the Visual Analogue Scale (VAS)
Pain will be assessed using a 0-10 VAS scale. Participants will report pain at baseline and at follow-up visits. Improvement will be quantified using the protocol-defined formula for pain reduction (NB).
Time frame
Baseline, 1 week, 1 month, and 3 months after treatment completion3
Change in swelling or oral discomfort (subjective assessment)
Participants will evaluate swelling or discomfort on a 0-10 numeric scale. Improvement will be calculated using the protocol-defined formula (NO) to quantify reduction of symptoms after treatment.
Time frame
Baseline, 1 week, 1 month, and 3 months after treatment completion4
Change in clinical grade using the Thonprasom scale (0-5)
Clinical severity of oral lichen planus will be evaluated using the Thonprasom grading system. Each lesion will be assigned a grade based on extent and morphology. Change in score over time will be used to assess therapeutic response.
Time frame
Baseline, 1 week, 1 month, and 3 months after treatment completionSponsors and contacts
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Source ClinicalTrials.gov