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Different Treatment Modalities for Oral Lichen Plan

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

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06681090
Enrollment
20
Registered
2024-11-08
Start date
2023-03-03
Completion date
2023-10-29
Last updated
2025-02-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oral Lichen Planus

Keywords

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

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.

Interventions

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

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.

Sponsors

Assiut University
CollaboratorOTHER
Al-Azhar University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

Masking description

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
The erosion sizeFrom enrollment to the end of treatment at 4 weeksThe 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 weekspain 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

MeasureTime frameDescription
Oral Health-Related Quality of Life (OHRQoL)From enrollment to the end of treatment at 4 weeksA 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.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026