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

Oral Lichen Planus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04991012
• Other study ID #: kb845/2020
• Status: Completed
• Phase: Phase 2
• Start date: February 8, 2020
• Est. completion date: June 10, 2021

Study information

• Verified date: June 2021
• Source: Wroclaw Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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 information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 10, 2021
• Est. primary completion date: March 8, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Lichen Planus
• Lichen Planus, Oral
• Oral Lichen Planus

Intervention

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

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

Locations

Country	Name	City	State
Poland	Wroclaw Medical University	Wroclaw	Dolnoslaskie

Sponsors (1)

Lead Sponsor	Collaborator
Wroclaw Medical University

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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