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
- Oral Lichen Planus
- Interventions
- Device: PDT Therapy
- Registration Number
- NCT04991012
- Lead Sponsor
- Wroclaw Medical University
- Brief Summary
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
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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
- histological diagnosis of OLP
- non smoker
- no diabetes melitus
- no hepatitis
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Triamcinolone (Substance) therapy side Triamcinolone (Substance) therapy side 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 photodynamic therapy side PDT Therapy 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
- Primary Outcome Measures
Name Time Method length of oral lichen planus 12 weeks The measurement was made with a periodontal probe PCP UNC 15 in millimeters
we measured the length of the lesionsheight of oral lichen planus 12 weeks The measurement was made with a periodontal probe PCP UNC 15 in millimeters
we measured the height
- Secondary Outcome Measures
Name Time Method computer analysis of autofluorescence of lesions 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
Trial Locations
- Locations (1)
Wroclaw Medical University
🇵🇱Wrocław, Dolnoslaskie, Poland