Clinical trial NCT06681090: Different Treatment Modalities for Oral Lichen Plan
Official title: Effectiveness of Low-Level Laser Therapy and Topical Steroid Therapy in the Management of Oral Lichen Planus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Oral Lichen Planus
Keywords: Low-Level Laser
Topical Steroid
0.1% triamcinolone acetonide
management of oral lichen planus
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
Collaborators: name: Assiut University
First posted: 2024-11-08
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: The erosion size
timeFrame: From enrollment to the end of treatment at 4 weeks"
measure: The Visual Analogue Scale (VAS)
timeFrame: From enrollment to the end of treatment at 4 weeks"
Secondary outcomes:
measure: Oral Health-Related Quality of Life (OHRQoL)
timeFrame: From enrollment to the end of treatment at 4 weeks"
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Faculty of Dentistry, Assiut University
Study officials:
affiliation: Faculty of Dentistry, Assiut University, Egypt
name: Ahmed F. Assistant Professor, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Faculty of Dentistry, Assiut University, Egypt
name: Rahma M. Lecturer, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Dental Medicine Faculty, Al-Azhar University (Assiut Branch), Assiut, Egypt
name: Asem K. Lecturer, PhD
role: STUDY_CHAIR
affiliation: Faculty of Dentistry, Al-Azhar University (Assiut Branch), Assiut, Egypt.
name: Mahmoud A. Professor, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.