Oral Lichen Planus Treatment

Universidad de Murcia

Status: Completed

Conditions: Oral Lichen Planus

Treatments: Radiation: Patients will be treated with localized PBM with a diode laser

Study type: Interventional

Funder types: Other

Identifiers

NCT05127083

2227/2018

Details and patient eligibility

About

Oral lichen planus (OLP) is a chronic inflammatory and immune-mediated disease affecting the oral mucosa. OLP presents with asymptomatic, lacelike white stripes and/or symptomatic red, ulcerated mucous membranes. Eating, drinking and oral hygiene procedures may be painful resulting in reduced quality of life (QOL). Photodynamic therapy (PDT) is a new suggestion for OLP treatment PDT is a successful treatment mo- dality for premalignant and malignant diseases of head and neck,gastrointestinal tract, lung, and skin

In this study, the effect of photodynamic therapy with topical corticosteroid in oral lichen planus patients was compared

Full description

In this study, the efficacy of toluidine blue-mediated photodynamic therapy and topical triamcinolone acetonide 0.2% on decreasing pain and size of OLP lesions was compared.

This randomized, clinical trial compared the therapeutic effect of photodynamic therapy on symptomatic OLP (atrophic/ erosive/ulcerative forms) with triamcinolone acetonide 0.2%. The protocol of the clinical trial, which was conducted according to the ethical principles of Helsinki Group I toluidine blue-mediated photodynamic therapy Group II photodynamic therapy GroupIII laser sham + triamcinolone acetonide 0.2%

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• . The patients with clinical or histopathological diagnosis of bilateral atrophic or erosive OLP (symptomatic OLP) who signed the written consent form were recruited.

Exclusion criteria

• Patients with drug-induced or contact lichenoid reactions, patients receiving any treatment for OLP in 2 months prior to the study, pregnant or lactating women, patients with uncontrolled systemic disease, and patients with photosensitivity

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

60 participants in 3 patient groups

toluidine blue-mediated photodynamic therapy

Experimental group

Description:

The number of points will be variable according to the lesion size. Patients will be treated with localized PBM with a diode laser with continuous wave +toluidine blue

Treatment:

Radiation: Patients will be treated with localized PBM with a diode laser

photodynamic therapy + gel

Active Comparator group

Description:

The number of points will be variable according to the lesion size.atients will be treated with localized PBM with a diode laser with continuous wave

Treatment:

Radiation: Patients will be treated with localized PBM with a diode laser

acetonide triamcinolone 0.2%+sham

Sham Comparator group

Description:

Patients will be treated with acetonide triamcinolone 0.2% for 30 consecutive days. Laser device will be positioned over the lesion but will be switched off to mask the treatment. Patients will be instructed to apply the gel in the entire lesion three times/days.The number of points will be variable according to the lesion size.

Treatment:

Radiation: Patients will be treated with localized PBM with a diode laser