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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

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04991012
Enrollment
30
Registered
2021-08-05
Start date
2020-02-08
Completion date
2021-06-10
Last updated
2021-08-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oral Lichen Planus

Keywords

photodynamic therapy

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

Interventions

DEVICEPDT 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

DRUGTriamcinolone (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

Sponsors

Wroclaw Medical University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Intervention model description

full contralateral split-mouth

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
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

Design outcomes

Primary

MeasureTime frameDescription
length of oral lichen planus12 weeksThe measurement was made with a periodontal probe PCP UNC 15 in millimeters we measured the length of the lesions
height of oral lichen planus12 weeksThe measurement was made with a periodontal probe PCP UNC 15 in millimeters we measured the height

Secondary

MeasureTime frameDescription
computer analysis of autofluorescence of lesions12 weeksBased 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

Countries

Poland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026