Ignite Creation Date:
2025-12-24 @ 12:00 PM
Ignite Modification Date:
2025-12-27 @ 4:10 PM
Study NCT ID:
NCT07121361
Status:
COMPLETED
Last Update Posted:
2025-08-13
First Post:
2025-08-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of Recurrent Aphthous Stomatitis Mouthwash System for the Treatment of Oral Ulcers
Sponsor:
G. d'Annunzio University
Organization:
Study Overview
Official Title:
Evaluation of the Efficacy of a Mouthwash Formulation for Minor Oral Ulcers: A Triple-Blind Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2025-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RASMA
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).
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| RA/0362820 | OTHER | Territorial Ethics Committee of the Abruzzi Region, Italy (C.Et.R.A.) ) | View |