Oral Lichen Planus Treatment

NCT ID: NCT05127083

Last Updated: 2021-11-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-04

Study Completion Date

2021-10-18

Brief Summary

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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

Detailed Description

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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%

Conditions

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Oral Lichen Planus

Keywords

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pain, oral lichen planus ; photodynamic therapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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toluidine blue-mediated photodynamic therapy

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

Group Type EXPERIMENTAL

Patients will be treated with localized PBM with a diode laser

Intervention Type RADIATION

Toluidine blue was applied on the lesions.The tissue were irradiated with a 660-nm diode laser InGaAlP

photodynamic therapy + gel

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

Group Type ACTIVE_COMPARATOR

Patients will be treated with localized PBM with a diode laser

Intervention Type RADIATION

Toluidine blue was applied on the lesions.The tissue were irradiated with a 660-nm diode laser InGaAlP

acetonide triamcinolone 0.2%+sham

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.

Group Type SHAM_COMPARATOR

Patients will be treated with localized PBM with a diode laser

Intervention Type RADIATION

Toluidine blue was applied on the lesions.The tissue were irradiated with a 660-nm diode laser InGaAlP

Interventions

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Patients will be treated with localized PBM with a diode laser

Toluidine blue was applied on the lesions.The tissue were irradiated with a 660-nm diode laser InGaAlP

Intervention Type RADIATION

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universidad de Murcia

OTHER

Sponsor Role lead

Responsible Party

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Pia Lopez Jornet

Investigador principal Head Oral Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Lopez-Jornet Pia

Murcia, N/A = Not Applicable, Spain

Site Status

Countries

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Spain

References

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Lavaee F, Shadmanpour M. Comparison of the effect of photodynamic therapy and topical corticosteroid on oral lichen planus lesions. Oral Dis. 2019 Nov;25(8):1954-1963. doi: 10.1111/odi.13188. Epub 2019 Oct 2.

Reference Type BACKGROUND
PMID: 31478283 (View on PubMed)

Hoseinpour Jajarm H, Asadi R, Bardideh E, Shafaee H, Khazaei Y, Emadzadeh M. The effects of photodynamic and low-level laser therapy for treatment of oral lichen planus-A systematic review and meta-analysis. Photodiagnosis Photodyn Ther. 2018 Sep;23:254-260. doi: 10.1016/j.pdpdt.2018.07.001. Epub 2018 Jul 10.

Reference Type BACKGROUND
PMID: 30006319 (View on PubMed)

Mostafa D, Moussa E, Alnouaem M. Evaluation of photodynamic therapy in treatment of oral erosive lichen planus in comparison with topically applied corticosteroids. Photodiagnosis Photodyn Ther. 2017 Sep;19:56-66. doi: 10.1016/j.pdpdt.2017.04.014. Epub 2017 Apr 25.

Reference Type BACKGROUND
PMID: 28450262 (View on PubMed)

Rakesh N, Clint JB, Reddy SS, Nagi R, Chauhan P, Sharma S, Sharma P, Kaur A, Shetty B, Ashwini S, Pavan Kumar T, Vidya GS. Clinical evaluation of photodynamic therapy for the treatment of refractory oral Lichen planus - A case series. Photodiagnosis Photodyn Ther. 2018 Dec;24:280-285. doi: 10.1016/j.pdpdt.2018.09.011. Epub 2018 Sep 24.

Reference Type BACKGROUND
PMID: 30261326 (View on PubMed)

Salinas-Gilabert C, Gomez Garcia F, Galera Molero F, Pons-Fuster E, Vander Beken S, Lopez Jornet P. Photodynamic Therapy, Photobiomodulation and Acetonide Triamcinolone 0.1% in the Treatment of Oral Lichen Planus: A Randomized Clinical Trial. Pharmaceutics. 2022 Dec 22;15(1):30. doi: 10.3390/pharmaceutics15010030.

Reference Type DERIVED
PMID: 36678659 (View on PubMed)

Other Identifiers

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2227/2018

Identifier Type: -

Identifier Source: org_study_id