Wroclaw Medical University
Wroclaw, Lower Silesian Voivodeship, 50-425, Poland
NCT Number: NCT04991012
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
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Notify Me18 year–85 year
All sexes
Interventional
Phase 2
Wroclaw, Lower Silesian Voivodeship, 50-425, Poland
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
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Other names: Photodynamic Therapy
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
Other names: Steroid therapy
Time frame: 12 weeks
The measurement was made with a periodontal probe PCP UNC 15 in millimeters
we measured the length of the lesions
Time frame: 12 weeks
The measurement was made with a periodontal probe PCP UNC 15 in millimeters
we measured the height
Time frame: 12 weeks
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
Wroclaw Medical University
Other
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