An interventional study of Mouthwash Product and Control in Recurrent Aphthous Ulcer and Recurrent Aphthous Stomatitis, sponsored by G. d'Annunzio University. Completed at 1 site in Italy. Per ClinicalTrials.gov, last updated 2025-08-13.
Sponsored by G. d'Annunzio University · Not applicable, Interventional, and Treatment
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:
63 studies on the registry are indexed under Stomatitis, Aphthous; 17 are open to participants now.
This study's enrollment of 60 is above the median of 41 across 54 interventional studies indexed under Stomatitis, Aphthous.
Browse Stomatitis, Aphthous studies →G. d'Annunzio University is the lead sponsor of 67 studies on the registry; 22 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Device: Mouthwash Product
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
Device: Control
DNA mouthwash
Placebo mouthwash
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
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
This study is completed, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
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G. d'Annunzio University