← Back to all trials
Not Yet Recruiting
NCT07910175
Curcumin-mediated Photodynamic Therapy Versus Photobiomodulation in the Treatment of Oral Erosive Lichen Planus
Conditions: Oral Lichen Planus
Sex: All
Ages: 18 Years – 65 Years
Healthy volunteers: No
Phase: NA
Enrollment: 42
Sponsor: Alexandria University
Location: Outpatient Clinic of Oral medicine Department, Faculty of Dentistry, Alexandria University, Egypt Alexandria
Summary
Background: Oral Lichen Planus (OLP) is a chronic, T-cell-mediated inflammatory disease of the oral mucosa, with the erosive form causing painful ulcerations and erosions, significantly impacting the patient's quality of life and carrying a risk of malignant transformation. While corticosteroids remain the first-line treatment, their long-term use is limited by significant local and systemic side effects. Consequently, there is a critical need for effective, non-invasive and safe alternative therapies. Photodynamic Therapy (PDT) and Photobiomodulation (PBM) have emerged as promising light-based modalities. Curcumin, a natural polyphenol, has gained attention as a safe and effective photosensitizer for PDT due to its anti-inflammatory and antioxidant properties.
Aim: This clinical trial aims to evaluate and compare the effect of nano-curcumin formulation incorporated into biodegradable mucoadhesive gel as a photosensitizer for Photodynamic Therapy (PDT) versus Photobiomodulation (PBM) in the treatment of oral erosive lichen planus.
Eligibility Criteria
Inclusion Criteria:
* Patients diagnosed clinically and histopathologically with erosive oral lichen planus without dysplastic features based on WHO criteria
* Patients diagnosed with oral erosive lichen planus refractory to conventional treatment
* Patients complaining of painful lesions with pain threshold at a minimum value of 4 on a standard Numerical Rating Scale (NRS)
* Therapeutic Washout: Absolute suspension of all localized or systemic corticosteroid / immunosuppressive regimens for at least 4 weeks prior to structural baseline evaluations
Exclusion Criteria:
* Pregnant or lactating females due to lack of standard safety parameters.
* Presence of secondary concurrent multi-system autoimmune pathologies.
* Lichenoid reactions: Lesions exhibiting definitive spatial localization to dental amalgam margins or secondary to active drug induction.
* Diagnosed systemic photosensitivity syndromes or secondary utilization of systemic photosensitizing therapeutic agents.
* Smokers
* Bad oral hygiene , severe periodontal disease
* Underlying systemic diseases like diabetes , hypertension , cardiac patients , pace makers
* Patients with extra oral manifestations
Source: ClinicalTrials.gov (NCT07910175). StuddyBuddy aggregates publicly available trial information.