Different Treatment Modalities for Oral Lichen Plan

Effectiveness of Low-Level Laser Therapy and Topical Steroid Therapy in the Management of Oral Lichen Planus

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.

Study Overview

• Status: Completed
• Conditions: Oral Lichen Planus
• Intervention / Treatment: Drug: 0.1% topical triamcinolone Acetonide preparation "Kenacourt-A Orabase"; Device: 980 nm diode laser

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 1

Contacts and Locations

Study Locations

• Egypt
  • Assiut, Egypt, 71515
    • Faculty of Dentistry, Assiut University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Topical Steroid Therapy of Erosive oral lichen planus; 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"; 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
Experimental: Low-Level Laser Therapy of Erosive oral lichen planus; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oral Health-Related Quality of Life (OHRQoL)	A month following the initial appointment, participants were asked about the OLP that had restricted their everyday activities. The 8 tasks included eating, talking, cleaning one's mouth, sleeping, smiling, laughing freely, maintaining emotional stability, performing strenuous physical labour, and interacting with others. { the minimum is 0 and maximum values is 5 }.a score of zero indicated never being afflicted, a score of 1 meant once a month, a score of 2 meant twice a month, scoring 3 indicated a frequency of once or twice weekly, 4 indicated 3 to 4 times weekly, and 5 signified daily or very daily occurrences.	From enrollment to the end of treatment at 4 weeks"

Collaborators and Investigators

• Sponsor: Al-Azhar University
• Collaborators: Assiut University
• Investigators: Principal Investigator: Ahmed F. Assistant Professor, PhD, Faculty of Dentistry, Assiut University, Egypt; Principal Investigator: Rahma M. Lecturer, PhD, Faculty of Dentistry, Assiut University, Egypt; Study Chair: Asem K. Lecturer, PhD, Dental Medicine Faculty, Al-Azhar University (Assiut Branch), Assiut, Egypt; Study Director: Mahmoud A. Professor, PhD, Faculty of Dentistry, Al-Azhar University (Assiut Branch), Assiut, Egypt.

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 3, 2023
• Primary Completion (Actual): September 25, 2023
• Study Completion (Actual): October 29, 2023

Study Registration Dates

• First Submitted: November 2, 2024
• First Submitted That Met QC Criteria: November 7, 2024
• First Posted (Actual): November 8, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 5, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Topical Steroid; Low-Level Laser; 0.1% triamcinolone acetonide; management of oral lichen planus
• Additional Relevant MeSH Terms: Mouth Diseases; Stomatognathic Diseases; Lichenoid Eruptions; Skin Diseases, Papulosquamous; Skin Diseases; Lichen Planus, Oral; Lichen Planus; Immunosuppressive Agents; Immunologic Factors; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Enzyme Inhibitors; Triamcinolone; Triamcinolone Acetonide; Triamcinolone hexacetonide; Triamcinolone diacetate
• Other Study ID Numbers: Management of Oral Lichen Plan

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No