Effectiveness of Recurrent Aphthous Stomatitis Mouthwash System for the Treatment of Oral Ulcers (NCT07121361) | Clinical Trial Compass
CompletedNot Applicable
Effectiveness of Recurrent Aphthous Stomatitis Mouthwash System for the Treatment of Oral Ulcers
Italy60 participantsStarted 2023-11-28
Plain-language summary
The purpose of the present research is to evaluate the efficacy of a gel formulation for a total treatment of 14 days for the treatment of traumatic or aphthous oral ulcers.
Who can participate
SexALL
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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.