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.
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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
60
DNA mouthwash
Placebo mouthwash
University of Chieti- Department of Innovative Technology in Medicine and Dentistry
Chieti, Abruzzo, Italy
Pain intensity
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.
Time frame: 14 days
Ulcers Dimensions
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.
Time frame: 14 days
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