According to recent research, microRNAs (miRNAs) may function as early disease indicators and contribute to the severity of a number of precancerous and malignant oral disorders. The aim of the present study, through a double-blind randomized controlled trial design, is to analyze in the gingival crevicular fluid (GCF) as a non-invasive approach the impact of topical clobetasol on miRNAs expression in subjects affected by oral lichen planus (OLP).
A double-blind randomized controlled clinical trial is conducted in order to evaluate the impact of topical clobetasol on GCF miRNAs expression in subjects with OLP and determine the statistical significance of the outcome variables. At least 60 patients with OLP, randomly allocated in two groups: placebo group with a 4% hydroxyethyl cellulose adhesive gel and the clobetasol group with the same gel containing clobetasol propionate 0,05%.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
62
Topic Clobetasol gel applied locally on OLP lesions.
Placebo oral gel applied locally on OLP lesions.
AOU Policlinico G. Rodolico
Catania, Catania, Italy
miRNAs GCF levels
The level of expression of different miRNAs in the GCF before and after treatment in the two groups. (Scale 0-4)
Time frame: 6 months
OLP disease severity scores
The eventual improvement in OLP symptoms, signs and disease severity scores after treatment in the two groups. (Scale 0-4)
Time frame: 6 months
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