Analysis of the Efficacy of Two Treatment Protocols for Patients with Symptomatic Oral Lichen Planus: A Randomized Clinical Trial

Simona Santonocito, Alessandro Polizzi, Rocco De Pasquale, Vincenzo Ronsivalle, Antonino Lo Giudice, Gaetano Isola, Simona Santonocito, Alessandro Polizzi, Rocco De Pasquale, Vincenzo Ronsivalle, Antonino Lo Giudice, Gaetano Isola

Abstract

Oral lichen planus (OLP) is a chronic, inflammatory, immune-mediated disease, which can alter the quality of life of patients. The aim of this randomized clinical trial was to compare the therapeutic efficacy of clobetasol oral gel 0.05% versus an anti-inflammatory in oral solution (mouthwash) in the management of patients suffering from symptomatic OLP. The secondary objective was to analyze which one of the two treatments induced a greater risk of developing side effects. Forty patients were assigned (20 patients for group), through a randomized design, to receive clobetasol gel 0.05% or an anti-inflammatory mouthwash, which contains calcium hydroxide, hyaluronic acid, umbelliferone and oligomeric pro-anthocyanidins) for three months. At baseline (T0) and after 3 months (T1), patients underwent dental and dermatological examinations to assess their symptoms (Numerical Pain Scale (NRS) score) and signs (Thongprasom score). Data were calculated using T-test for the dependent variable, Wilcoxon test and Mann-Whitney u test. Both clobetasol and anti-inflammatory resulted in a statistically significant reduction of signs, (p < 0.001 and p = 0.02, respectively) and symptoms (p < 0.001 for clobetasol and p = 0.02 for anti-inflammatory). In conclusion, the results evidenced that, compared to clobetasol, the anti-inflammatory was less effective in determining the reduction of signs and symptom in OLP patients.

Trial registration: ClinicalTrials.gov NCT04673916.

Keywords: Thongprasom’s Score; calcium hydroxide; clobetasol; hyaluronic acid; oligomeric pro-anthocyanidins; oral lichen planus; oral solution; therapy; umbelliferone.

Conflict of interest statement

The authors declare no conflict of interest.

Figures

Figure 1
Figure 1
Flow chart of the study.
Figure 2
Figure 2
Intra-oral photos of some of the subjects who joined the clinical trial at T0 and T1. The action of the drug on the lesions can be seen after 12 weeks of treatment (Clobetasol group).
Figure 3
Figure 3
Intra-oral photos of some of the subjects who joined the clinical trial at T0 and T1. The action of the drug on the lesions can be seen after 12 weeks of treatment (Anti-inflammatory group).

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