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Photobiomodulation, Er:YAG Laser, and Clobetasol in the Treatment of Oral Lichen Planus.
Sponsor: Medical University of Silesia
Summary
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, Er:YAG laser 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, surgical laser once weekly, 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.
Official title: Effectiveness of Photobiomodulation, Er:YAG Laser, and Clobetasol in the Treatment of the Erosive Form of Oral Lichen Planus - a Randomized Clinical Trial.
Key Details
Gender
All
Age Range
20 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2025-12-01
Completion Date
2026-06
Last Updated
2025-12-12
Healthy Volunteers
No
Interventions
Photobiomodulation using 635 nm diode laser
Photobiomodulation 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.
Er:YAG laser mucosal treatment
Er:YAG laser therapy is performed using pulsed energy at 50-80 mJ and 10 Hz (0.8 W) with a 300 µs pulse duration. Active cooling with water and air settings of 5/5 is applied. A flat fiber tip is used in a noncontact mode at a distance of approximately 3 mm from the lesion. The laser provides controlled superficial ablation of affected mucosal tissue to promote healing. Sessions occur once weekly until full epithelial recovery or for a maximum of four treatments. This intervention evaluates the therapeutic effect of Er:YAG laser-assisted tissue removal in erosive oral lichen planus.
Clobetasol propionate 0.05 percent topical application
Participants 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.
Locations (1)
Department of Periodontology and Oral Mucosa Diseases
Zabrze, Silesian Voivodeship, Poland