Different Treatment Modalities for Oral Lichen Plan

Phase 1

Completed

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

• Registration Number: NCT06681090
• Lead Sponsor: Al-Azhar University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-03-03
• Primary Completion: 2023-09-25
• Study Completion: 2023-10-29
• Study First Submitted: 2024-11-02
• Study First Submitted QC: 2024-11-07
• Study First Posted: 2024-11-08
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-05
• Last Update Posted: 2025-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Topical Steroid Therapy of Erosive oral lichen planus	0.1% topical triamcinolone Acetonide preparation "Kenacourt-A Orabase"	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
Low-Level Laser Therapy of Erosive oral lichen planus	980 nm diode laser	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.

Primary Outcome Measures

Name	Time	Method
The erosion size	From enrollment to the end of treatment at 4 weeks"	The maximal diameter (mm) and width (mm) were measured perpendicularly using a calibrated periodontal probe
The Visual Analogue Scale (VAS)	From enrollment to the end of treatment at 4 weeks"	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 }

Secondary Outcome Measures

Name	Time	Method
Oral Health-Related Quality of Life (OHRQoL)	From enrollment to the end of treatment at 4 weeks"	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.

Trial Locations

Locations (1)

Faculty of Dentistry, Assiut University; 🇪🇬 Assiut, Egypt