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

G. d'Annunzio University

Status: Completed

Conditions: Recurrent Aphthous Ulcer; Recurrent Aphthous Stomatitis

Treatments: Device: Mouthwash Product; Device: Control

Study type: Interventional

Funder types: Other

Identifiers

NCT07121361

RA/0362820 (Other Identifier)

Details and patient eligibility

About

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.

Full 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).

Enrollment: 60 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups, including a placebo group

DNA mouthwash

Active Comparator group

Description:

The compound is characterized by a formulation that ensures effective action on the film-forming component. The presence of DNA fractions increases the viscosity of the solutions and increases the hydration of the mucous membranes with a consequent improvement in trophism for oral ulcers. The treatment indications are to delay and prevent oral ulcers and the formation of bacterial plaque; prevent irritation of the gums and oral cavity, even in wearers of prostheses and orthodontic implants accompanied by problems with dental support structures; after tooth extraction; before and after any dental surgery. The patients will be instructed to rinse the mouth and ulcers with the mouthwash twice a day after oral hygiene for 14 days

Treatment:

Device: Mouthwash Product

Placebo mouthwash

Placebo Comparator group

Description:

The placebo will be deprived by all components. The patients will be instructed to rinse the mouth and ulcers with the mouthwash twice a day after oral hygiene for 14 days

Treatment:

Device: Control