A double-blind placebo-controlled trial is conducted in order to evaluate the efficacy of Fluocinonide 0,05% and determinate the statistical significance of the outcome variables. Oral cavity lichen is a chronic inflammatory condition affecting the mucosa of the oral cavity , which significantly reduces the quality of life of affected individuals.
A double-blind placebo-controlled study was conducted to evaluate the clinical efficacy of Fluocinonide 0.05% oral gel and determine the statistical significance of outcome variables. 20 patients with Oral Lichen Planus were divided by a randomization system, into two groups: case group treated with Fluocinonide 0.05% oral gel and applied to oral lesions 2 times a day for 1 month and a placebo group as a control group; with 2 months of follow-up.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
47
Application of Fluocinonide oral gel on oral syntomatic lesions
Application of placebo oral gel on oral lesions
AOU Policlinico G. Rodolico
Catania, Italy
Assessment of sings
Assessment of sings using the Thongprasom scoring system at baseline and after 2 months
Time frame: 3 months
Assessment of symptoms
Assessment of symptoms using the VAS scale at baseline and after 2 months
Time frame: 3 months
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