Different Treatment Modalities for Oral Lichen Plan

NCT06681090 | Completed Phase 1 DMC

• 1 other identifier: Management of Oral Lichen Plan
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of applications of Low-Level Laser and Topical Steroid in the Management of Oral Lichen Planus is to learn if intervention can by relieve pain, decreasing inflammation, and facilitating tissue healing in20 patients who were suffering from erosive oral lichen planus. The main questions it aims to answer are which is better and more effective as treatment modality. The erosion size (mm2) measured on the first day and 4 weeks later. Oral Health-Related Quality of Life questionnaire manipulated. Researchers will take Low-Level Laser and Topical Steroid in the Management of Oral Lichen Planus to see if it could be used as separate treatment option or as combination.

Conditions

Oral Lichen Planus

Keywords

Low-Level Laser; Topical Steroid; 0.1% triamcinolone acetonide; management of oral lichen planus

Outcome Measures

Primary Outcomes (2)

• The erosion size

  The maximal diameter (mm) and width (mm) were measured perpendicularly using a calibrated periodontal probe

  From enrollment to the end of treatment at 4 weeks"

• The Visual Analogue Scale (VAS)

  pain ratings span from zero (indicating the absence of pain) to 10 (representing extremely intense pain) along a horizontal line values. { the minimum is 0 and maximum is 10 }

  From enrollment to the end of treatment at 4 weeks"

Secondary Outcomes (1)

• Oral Health-Related Quality of Life (OHRQoL)

  From enrollment to the end of treatment at 4 weeks"

Study Arms (2)

Topical Steroid Therapy of Erosive oral lichen planus

EXPERIMENTAL

topical application of 0.1% triamcinolone acetonide and photo biomodulation on erosive oral lichen planus, 3 times daily and a miconazole oral gel once daily, for 4 weeks

Drug: 0.1% topical triamcinolone Acetonide preparation "Kenacourt-A Orabase"

Low-Level Laser Therapy of Erosive oral lichen planus

EXPERIMENTAL

Photo biomodulation with laser therapy twice a week for 8 sessions over 4 weeks, utilizing a 980 nm diode laser with an output power of 300 mw.

Device: 980 nm diode laser

Interventions

0.1% topical triamcinolone Acetonide preparation "Kenacourt-A Orabase" DRUG

The patients were administered topical corticosteroids in the form of a 0.1% triamcinolone acetonide preparation (Kenacort TM 0.1% Abbott). The medication was to be used 3 times every day for 4 weeks or until the lesion has healed, whichever occurs first. After applying the gel, the patients were instructed not to consume any fluids or food for at least 1 hour. In addition, a topical antifungal treatment consisting of Miconazole oral gel at a concentration of 2% should be applied once a day for 4 weeks

Topical Steroid Therapy of Erosive oral lichen planus

980 nm diode laser DEVICE

First group (Group A) underwent PBM therapy using a 980 nm diode laser (elexxion nano dental laser with a flat top handpiece). The therapy included 8 sessions for 4 weeks, with 2 sessions conducted per week, all administered by the same operator. The energy was evenly distributed across all the mucosal lesions and the surrounding tissues within a 0.5 cm range using a spot-technique method with little overlap.

Low-Level Laser Therapy of Erosive oral lichen planus

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients who were monitored for OLP.
• clinical and histopathological finding of OLP in accordance with van der Meij 2003.
• being over 18 years old.

You may not qualify if:

• Patients with systemic disorders, pregnancy, using drugs, smoking, lesions in contact with dental amalgams, and cutaneous or other mucosal involvement at the time of treatment were excluded.

Sponsors & Collaborators

• Al-Azhar University: lead
• Assiut University: collaborator

Study Sites (1)

Faculty of Dentistry, Assiut University

Asyut, Asyut Governorate, 71515, Egypt

Location

Related Publications (3)

• van der Meij EH, Schepman KP, van der Waal I. The possible premalignant character of oral lichen planus and oral lichenoid lesions: a prospective study. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2003 Aug;96(2):164-71. doi: 10.1016/s1079-2104(03)00305-6.

  PMID: 12931088 BACKGROUND

• Ruiz Roca JA, Lopez Jornet P, Gomez Garcia FJ, Marcos Aroca P. Effect of Photobiomodulation on Atrophic-Erosive Clinical Forms of Oral Lichen Planus: A Systematic Review. Dent J (Basel). 2022 Nov 27;10(12):221. doi: 10.3390/dj10120221.

  PMID: 36547037 BACKGROUND

• Bhatt G, Gupta S, Ghosh S. Comparative efficacy of topical aloe vera and low-level laser therapy in the management of oral lichen planus: a randomized clinical trial. Lasers Med Sci. 2022 Apr;37(3):2063-2070. doi: 10.1007/s10103-021-03480-1. Epub 2021 Dec 1.

  PMID: 34853932 BACKGROUND

MeSH Terms

Conditions

Lichen Planus, Oral

Interventions

Lasers, Semiconductor

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Lichen Planus; Lichenoid Eruptions; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Lasers; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Study Officials

• Ahmed F. Assistant Professor, PhD

  Faculty of Dentistry, Assiut University, Egypt

  PRINCIPAL INVESTIGATOR

• Rahma M. Lecturer, PhD

  Faculty of Dentistry, Assiut University, Egypt

  PRINCIPAL INVESTIGATOR

• Asem K. Lecturer, PhD

  Dental Medicine Faculty, Al-Azhar University (Assiut Branch), Assiut, Egypt

  STUDY CHAIR

• Mahmoud A. Professor, PhD

  Faculty of Dentistry, Al-Azhar University (Assiut Branch), Assiut, Egypt.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Out of all the researchers, only one had knowledge of the patients' assigned groups. Neither the therapies nor their efficacy was evaluated by this unblinded researcher. There was a lack of treatment blinding for patients.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: November 2, 2024
• First Posted: November 8, 2024
• Study Start: March 3, 2023
• Primary Completion: September 25, 2023
• Study Completion: October 29, 2023
• Last Updated: February 7, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)