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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-28

Study Completion Date

2024-02-24

Brief Summary

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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.

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Detailed Description

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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

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Recurrent Aphthous Ulcer Recurrent Aphthous Stomatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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DNA mouthwash

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

Group Type ACTIVE_COMPARATOR

Mouthwash Product

Intervention Type DEVICE

DNA mouthwash

Placebo mouthwash

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

Group Type PLACEBO_COMPARATOR

Control

Intervention Type DEVICE

Placebo mouthwash

Interventions

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Mouthwash Product

DNA mouthwash

Intervention Type DEVICE

Control

Placebo mouthwash

Intervention Type DEVICE

Eligibility Criteria

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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.

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes