Oral Lichen Planus Treatment
- Conditions
- Oral Lichen Planus
- Interventions
- Radiation: Patients will be treated with localized PBM with a diode laser
- Registration Number
- NCT05127083
- Lead Sponsor
- Universidad de Murcia
- Brief Summary
Oral lichen planus (OLP) is a chronic inflammatory and immune-mediated disease affecting the oral mucosa. OLP presents with asymptomatic, lacelike white stripes and/or symptomatic red, ulcerated mucous membranes. Eating, drinking and oral hygiene procedures may be painful resulting in reduced quality of life (QOL). Photodynamic therapy (PDT) is a new suggestion for OLP treatment PDT is a successful treatment mo- dality for premalignant and malignant diseases of head and neck,gastrointestinal tract, lung, and skin
In this study, the effect of photodynamic therapy with topical corticosteroid in oral lichen planus patients was compared
- Detailed Description
In this study, the efficacy of toluidine blue-mediated photodynamic therapy and topical triamcinolone acetonide 0.2% on decreasing pain and size of OLP lesions was compared.
This randomized, clinical trial compared the therapeutic effect of photodynamic therapy on symptomatic OLP (atrophic/ erosive/ulcerative forms) with triamcinolone acetonide 0.2%. The protocol of the clinical trial, which was conducted according to the ethical principles of Helsinki Group I toluidine blue-mediated photodynamic therapy Group II photodynamic therapy GroupIII laser sham + triamcinolone acetonide 0.2%
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
- . The patients with clinical or histopathological diagnosis of bilateral atrophic or erosive OLP (symptomatic OLP) who signed the written consent form were recruited.
- Patients with drug-induced or contact lichenoid reactions, patients receiving any treatment for OLP in 2 months prior to the study, pregnant or lactating women, patients with uncontrolled systemic disease, and patients with photosensitivity
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description acetonide triamcinolone 0.2%+sham Patients will be treated with localized PBM with a diode laser Patients will be treated with acetonide triamcinolone 0.2% for 30 consecutive days. Laser device will be positioned over the lesion but will be switched off to mask the treatment. Patients will be instructed to apply the gel in the entire lesion three times/days.The number of points will be variable according to the lesion size. toluidine blue-mediated photodynamic therapy Patients will be treated with localized PBM with a diode laser The number of points will be variable according to the lesion size. Patients will be treated with localized PBM with a diode laser with continuous wave +toluidine blue photodynamic therapy + gel Patients will be treated with localized PBM with a diode laser The number of points will be variable according to the lesion size.atients will be treated with localized PBM with a diode laser with continuous wave
- Primary Outcome Measures
Name Time Method Change Thongprasom sign scoring Participants will be evaluated at baseline (Day 0) ; day 7: day 14 day and 28 day a score of 0 for normal healthy mucosa, 1 for lesions with only white striae, 2 for mixed keratotic and atrophic or erythematous lesions \< 1 cm2 in size, 3 for keratotic and atrophic or erythematous lesions more than 1 cm2 in size, 4 for erosive/ulcerative lesions smaller than 1 cm2 , and 5 for erosive/ulcerative lesions larger than 1 cm2
Change Assessment of Pain of OLP Participants will be evaluated at baseline (Day 0) ; day 7: day 14 day and 28 day The pain will be assessed by applying a Visual Analog Scale, consisting of a 100-mm line numbered in centimeters, with two closed ends. One end is labeled "0" and the other "100", meaning no pain and terrible pain, respectively. Each patient will be instructed to mark a vertical line according to the best value that matches the intensity of pain during the evaluation.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Lopez-Jornet Pia
🇪🇸Murcia, N/A = Not Applicable, Spain