Evaluation of the Effectiveness of Photodynamic Therapy in the Treatment of Lesions of the Lichen Planus Type in the Oral Mucosa and Its Diagnostics With the Use of Autofluorescence, in Various Wavelength Ranges, in Combination With the Use of Texture Analysis and Fractal Dimension

Study Overview
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Brief Summary
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Lesions of the lichen planus type within the oral mucosa are now considered a potentially cancerous condition. One of the minimally invasive methods of treating these lesions is photodynamic therapy, and the gold standard in therapy is topical steroid administration

Detailed Description
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Lichen planus shows an irregular shape, which is quite difficult to measure objectively, which is important in assessing the effectiveness of treatment. Patients will be treated in protocol split mouth with the treatment of lesions on one cheek with a steroid (on an adhesive plaster) and on the other - photodynamic therapy with a foot sensitizer in the form of a methylene blue also on an adhesive plaster The treatment evaluation procedure will consist of taking a series of intraoral photographs. These photos will be taken at each visit. This procedure will involve taking pictures traditionally in white light and in the spectrum of 405 nm, 460 nm and 405 + 460 nm (using the unique feature of the prototype laser - emission of two wavelengths simultaneously) in order to induce autofluorescence of the mucosa and treated lesions to better visualize them A prospective, randomized, single-blind 12-week clinical trial of full contralateral split-mouth in patients with bilateral erythematous or erosive lichen planus in the mouth.On one side, the OLP lesion eligible for treatment was subjected to photodynamic therapy using methylene blue in four sessions every 2 days. olp on the other side was treated with the administration of the steroid triamcinolone for 8 days The clinical evaluation of the evolution of OLP eruptions was performed within 12 weeks of qualifying for treatment: at baseline, at the end of both treatments (day 8) and after the next 11 weeks

Official Title
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Evaluation of the Effectiveness of Photodynamic Therapy in the Treatment of Lesions of the Lichen Planus Type in the Oral Mucosa and Its Diagnostics With the Use of Autofluorescence, in Various Wavelength Ranges, in Combination With the Use of Texture Analysis and Fractal Dimension

Conditions
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Oral Lichen Planus

Intervention / Treatment
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* Device: PDT Therapy
* Drug: Triamcinolone (Substance) therapy side


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: histological diagnosis of OLP non smoker no diabetes melitus no hepatitis Exclusion Criteria: diabetes melitus hepatitis occurrence dysplasia in the histopathological specimen; use of lichenoid reaction inducing medication and presence of amalgam fillings nearby the lesions; interventions for OLP in the previous 12 weeks; pregnant or breastfeeding women; proved or suspected hypersensitivity to any of the chemicals used in the treatment

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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
Interventional Model Description: full contralateral split-mouth
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: photodynamic therapy side<br>On one side, the OLP lesion eligible for treatment was subjected to photodynamic therapy in four sessions every 2 days.Using as photosensitizer Methylen blue for 10min the lesion was irradiated with a 650 nm semiconductor laser at a dose of 120 J / cm2 | Device: PDT Therapy<br>* the olp was photosensitized with methylen blue and was irradiated with a semiconductor laser with a wavelength of 650 nm, using a dose of 120 J / cm2 and power density<br>* Other names: Photodynamic Therapy;|
| Active Comparator: Triamcinolone (Substance) therapy side<br>on the other side The OLP on the other side was treated by daily sticking a cut-to-size carrier with 0.05% triamcinolone acetonide for 8 days | Drug: Triamcinolone (Substance) therapy side<br>* th The OLP on the other side was treated by daily sticking a cut-to-size carrier with 0.05% triamcinolone acetonide for 8 days<br>* Other names: Steroid therapy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| length of oral lichen planus | The measurement was made with a periodontal probe PCP UNC 15 in millimeters we measured the length of the lesions | 12 weeks | 
| height of oral lichen planus | The measurement was made with a periodontal probe PCP UNC 15 in millimeters we measured the height | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| computer analysis of autofluorescence of lesions | Based on photos taken in various light spectrum and fractal analysis of changes In this study, we used two wavelengths: 405, 450 and 405+450 nm together for the autofluorescence of lesions All fractal analysis was performed in ImageJ version 1.53e (Image Processing and Analysis in Java) Applied the intensity difference fractal dimension counting method. We measured the size of oral lichen planus on photos taken with different light wave using computer program as mentioned above | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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photodynamic therapy