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
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- length of oral lichen planus
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
photodynamic therapy side
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
Intervention: PDT Therapy (Device)
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
Intervention: Triamcinolone (Substance) therapy side (Drug)
Outcomes
Primary Outcomes
length of oral lichen planus
Time Frame: 12 weeks
The measurement was made with a periodontal probe PCP UNC 15 in millimeters we measured the length of the lesions
height of oral lichen planus
Time Frame: 12 weeks
The measurement was made with a periodontal probe PCP UNC 15 in millimeters we measured the height
Secondary Outcomes
- computer analysis of autofluorescence of lesions(12 weeks)