Recurrent Aphthous Ulcer, Recurrent Aphthous Stomatitis
Conditions
Keywords
Ulcers, Oral Hygiene, Oral care
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).
Interventions
DEVICEMouthwash Product
DNA mouthwash
DEVICEControl
Placebo mouthwash
Sponsors
G. d'Annunzio University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Italy
Outcome results
None listed