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Completed

NCT Number: NCT06681090

Different Treatment Modalities for Oral Lichen Plan

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Faculty of Dentistry, Assiut University

Asyut, Asyut Governorate, 71515, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

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.

Primary outcomes

  1. The erosion size

    Time frame: 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

  2. The Visual Analogue Scale (VAS)

    Time frame: 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 outcomes

  1. Oral Health-Related Quality of Life (OHRQoL)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Al-Azhar University

Other

Collaborators

  • Assiut University

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Nov 8, 2024
Registry last updated
Feb 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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