Oral Lichen Planus Treatment

Study Overview
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Brief Summary
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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
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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%

Official Title
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Oral Lichen Planus Photodynamic Treatment

Conditions
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Oral Lichen Planus

Intervention / Treatment
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* Radiation: Patients will be treated with localized PBM with a diode laser


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: . The patients with clinical or histopathological diagnosis of bilateral atrophic or erosive OLP (symptomatic OLP) who signed the written consent form were recruited. Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: toluidine blue-mediated photodynamic therapy<br>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 | Radiation: Patients will be treated with localized PBM with a diode laser<br>* Toluidine blue was applied on the lesions.The tissue were irradiated with a 660-nm diode laser InGaAlP<br>|
| Active Comparator: photodynamic therapy + gel<br>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 | Radiation: Patients will be treated with localized PBM with a diode laser<br>* Toluidine blue was applied on the lesions.The tissue were irradiated with a 660-nm diode laser InGaAlP<br>|
| Sham Comparator: acetonide triamcinolone 0.2%+sham<br>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. | Radiation: Patients will be treated with localized PBM with a diode laser<br>* Toluidine blue was applied on the lesions.The tissue were irradiated with a 660-nm diode laser InGaAlP<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change Assessment of Pain of OLP | 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. | Participants will be evaluated at baseline (Day 0) ; day 7: day 14 day and 28 day | 
| Change Thongprasom sign scoring | 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 | Participants will be evaluated at baseline (Day 0) ; day 7: day 14 day and 28 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pain, oral lichen planus ; photodynamic therapy