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Completed

NCT Number: NCT04991012

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

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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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Wroclaw Medical University

Wroclaw, Lower Silesian Voivodeship, 50-425, Poland

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PDT Therapy

Device

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

Triamcinolone (Substance) therapy side

Drug

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

Primary outcomes

  1. 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

  2. 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

  1. computer analysis of autofluorescence of lesions

    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

Sponsors and collaborators

Lead sponsor

Wroclaw Medical University

Other

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Aug 5, 2021
Registry last updated
Aug 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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