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

Not Applicable

Completed

• Conditions: Recurrent Aphthous Ulcer; Recurrent Aphthous Stomatitis

• Registration Number: NCT07121361
• Lead Sponsor: G. d'Annunzio University

Brief 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.

Detailed Description

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:

1. Registration of the superficial temperature of the mucous membranes using Infrared Thermography.

2. Ulcer Severity Score (USS).

Study Timeline

• Study Start: 2023-11-28
• Primary Completion: 2024-01-10
• Study Completion: 2024-02-24
• Status Verified: 2025-08
• Study First Submitted: 2025-08-01
• Study First Submitted QC: 2025-08-08
• Last Update Submitted: 2025-08-08
• Study First Posted: 2025-08-13
• Last Update Posted: 2025-08-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Pain intensity	14 days	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.
Ulcers Dimensions	14 days	Size of each ulcer measured through a sheet of clear plastic will be applied directly to the ulcer by tracing the circumference of the ulcer and then placed on a graph paper and the number of mm2 units included within the drawn area will be counted.

Trial Locations

Locations (1)

University of Chieti- Department of Innovative Technology in Medicine and Dentistry; 🇮🇹 Chieti, Abruzzi, Italy