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

Sponsor

Wroclaw Medical University (Other)

Overall Status

Completed

CT.gov ID

NCT04991012

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

1.9

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Oral Lichen Planus	Device: PDT Therapy Drug: Triamcinolone (Substance) therapy side	Phase 2

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

Actual Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

full contralateral split-mouthfull contralateral split-mouth

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Feb 8, 2020

Actual Primary Completion Date :

Mar 8, 2021

Actual Study Completion Date :

Jun 10, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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	Device: PDT Therapy 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
Active Comparator: 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	Drug: Triamcinolone (Substance) therapy side 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

Arm

Intervention/Treatment

Experimental: 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

Device: PDT Therapy

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

Active Comparator: 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

Drug: Triamcinolone (Substance) therapy side

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

Outcome Measures

Primary Outcome Measures

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 lesions
height 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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

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