NCT07121361

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

Evaluation of the Efficacy of a Mouthwash Formulation for Minor Oral Ulcers: A Triple-Blind Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: G. d'Annunzio University · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Accepted

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).

Conditions

• Recurrent Aphthous Ulcer
• Recurrent Aphthous Stomatitis

Interventions

Type	Name	Description
DEVICE	Mouthwash Product	DNA mouthwash
DEVICE	Control	Placebo mouthwash

Timeline

• Start date: 2023-11-28
• Primary completion: 2024-01-10
• Completion: 2024-02-24
• First posted: 2025-08-13
• Last updated: 2025-08-13

Locations

1 site across 1 country: Italy