Effectiveness of a mouthwash formulation for minor oral ulcers: a triple-blind randomized controlled trial
Mouthwash Formulation for Minor Oral Ulcers
Authors
Felice Lorusso, Sergio Alexandre Gherke, Giuliano Ascani, Sergio Tari Rexhep, Antonio Scarano
Abstract
The present investigation aimed to evaluate the clinical effectiveness and safety of a dedicated mouthwash formulation for the treatment of minor oral ulcers. A 2-week, double-arm, triple-blind, placebo-controlled randomized controlled trial was designed, consisting of two mouthwashes: Group Test (test formulation) and Group Control (placebo). The clinical efficacy has been assessed using the following scores and clinical parameters: pain intensity, measured using the VAS, Ulcer Severity Score (USS)—recording of the surface temperature of the mucous membranes by Infrared Thermography. The main clinical outcomes considered were ulcer count, lesion size, lesion disease duration, disease-free period, perceived pain, and residual scarring. A significant difference in pain level and USS score was detected in favor of the test group compared with the control group (p<0.05). No differences have been detected considering the temperature changes at 7 days and 2 weeks follow-up. The findings suggest that the treatment can produce a significant decrease in oral ulceration pain and symptoms and is useful in improving the clinical course of oral ulcers.
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