Effectiveness of Photobiomodulation, Er:YAG Laser, and Clobetasol in the Treatment of the Erosive Form of Oral Lichen Planus - a Randomized Clinical Trial.

Status: Recruiting
Location: See location...
Intervention Type: Device, Drug
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 20
Maximum Age: 70
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Poland
Department of Periodontology and Oral Mucosa Diseases
RECRUITING
Zabrze
Contact Information
Primary
Rafał Wiench, Professor, PhD, DMD
rwiench@sum.edu.pl
0048531770099
Backup
Jakub Fiegler-Rudol
jakub.fieglerrudol@gmail.com
0048574004884
Time Frame
Start Date: 2025-12-01
Estimated Completion Date: 2026-06
Participants
Target number of participants: 60
Treatments
Experimental: Photobiomodulation (PBM)
Participants in this arm receive photobiomodulation using a 635 nm diode laser delivered in continuous mode. Energy parameters follow a fixed protocol with 4 J/cm² fluence, 100 mW power, and 15 seconds per treatment point using a noncontact technique. Applications are performed twice weekly until complete epithelial healing or a maximum of eight sessions. This arm evaluates the regenerative and anti-inflammatory effects of PBM for erosive oral lichen planus.
Experimental: Er:YAG Laser Therapy
Participants in this arm undergo Er:YAG laser treatment using pulsed energy with active cooling. The protocol applies controlled ablation of superficial mucosal lesions while minimizing thermal diffusion. Treatment is performed once weekly until full healing or a maximum of four sessions. This arm evaluates whether Er:YAG laser-assisted tissue removal supports faster healing and symptom reduction in erosive oral lichen planus.
Experimental: Topical Clobetasol 0.05 percent
Participants receive standard therapy with topical clobetasol propionate 0.05 percent. The medication is applied to clean, dry oral mucosa twice daily for thirty days following clinical guidelines for erosive oral lichen planus. This arm serves as the comparator for evaluating the effectiveness of laser-based treatments relative to established corticosteroid therapy.
Related Therapeutic Areas
Sponsors
Leads: Medical University of Silesia

This content was sourced from clinicaltrials.gov