Efficacy of photobiomodulation on oral lichen planus: a protocol study for a double-blind, randomised controlled clinical trial

Abstract

Introduction: Oral lichen planus (OLP) is an idiopathic chronic mucocutaneous disease with a wide range of clinical manifestations, including white reticular patches, erosive/ulcerative and atrophic lesions, both associated with intense symptomatology. Topical corticosteroids are commonly used as standard therapy. However, patients frequently present relapses after the discontinuation of treatment as well as developing resistance to corticosteroid therapy. Photobiomodulation (PBM) has been shown to be a potential therapeutic tool to treat inflammatory disorders, including OLP. The aim of this study was to compare the efficacy of PBM (660 nm) with corticosteroid therapy with clobetasol propionate 0.05% for the treatment of OLP.

Methods and analysis: Forty-four patients with symptomatic and histopathological diagnosis of OLP will be randomised into two experimental groups in a double-blind manner: control group (n=22): clobetasol propionate 0.05%+placebo PBM, and experimental group (n=22): PBM (λ=660 nm, power 100 mW, radiant exposure: 177 J/cm² and 0.5J per point)+placebo gel. Laser will be applied 2×/week for 1 month and clobetasol propionate three times a day for 30 days and the same for placebo treatments. The primary variable (pain) and the secondary variables (clinical score, evaluation of functional scores, clinical resolution, OLP recurrence, quality of life and anxiety and depression) will be evaluated at the baseline, once a week during treatment (depending on the variables) and after 30 days and 60 days of follow-up. Pain will be evaluated using visual analogue scale and clinical characteristics will be scored using the Thongprasom Index. The quality of life and anxiety and depression will be evaluated by Oral Health Impact Profile-14 questionnaire and by Hospital Anxiety and Depression Scale for anxiety scale, respectively. The serum and salivary levels of interleukin (IL)-6, IL-10, IL-1β, INF-γ and tumour necrosis factor-α will be evaluated by ELISA at baseline and at the end of treatment.

Ethics and dissemination: This protocol was approved (#2.375.410) by the Nove de Julho University (UNINOVE) Research Ethics Committee. The data gathered using this protocol will be published in a peer-reviewed journal.

Trial registration number: NCT03320460.

Keywords: clinical response; corticosteroid; cytokines; oral lichen planus; photobiomodulation.

Figure 1

Flow chart of the study. IL, interleukin; TNF-α, tumour necrosis factor-α.