Effectiveness of Recurrent Aphthous Stomatitis Mouthwash System for the Treatment of Oral Ulcers

Primary Objective

Evaluation of the clinical efficacy of the treatment using the following scores and clinical parameters:

Pain intensity, measured using the VAS (Visual Analogue Scale), consisting of a 10 cm line, where 0 indicates no pain and 10 indicates intense pain.

Size of each ulcer.

Secondary Objectives

Evaluation of the following scores and clinical parameters:

• Registration of the superficial temperature of the mucous membranes using Infrared Thermography.
• Ulcer Severity Score (USS).

Inclusion criteria

• Patients with at least one well-defined oral ulcer.
• Patients with no cognitive disorders able to provide mouthwash treatment independently

Exclusion criteria

• Proven intolerance or allergy to the product.
• Patients with a hematological deficit such as anemia, iron deficiency, vitamin B12 and/or folic acid
• No systemic diseases including ulcerative colitis, Crohn's disease, Behçet's syndrome with recurrent aphthous lesions; alcohol and tobacco consumption;
• No history of allergies;
• No previously treatment of oral ulcers with topical steroids, vitamins, antibiotics, antihistamines, oral retinoids, or immunomodulatory agents within three months prior to entering the study;
• No non-steroidal anti-inflammatory drugs or mouthwash administrations for the treatment of the ulcer within 72 hours before entering the study.
• Pregnants or breastfeeding patients.