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| ID | Type | Description | Link |
|---|---|---|---|
| RA/0362820 | Other Identifier | Territorial Ethics Committee of the Abruzzi Region, Italy (C.Et.R.A.) ) |
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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DNA mouthwash | Active Comparator | 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 |
|
| Placebo mouthwash | Placebo Comparator | 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mouthwash Product | Device | DNA mouthwash |
| |
| Control |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 14 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Prof. Antonio Scarano Antonio Scarano, MD DDS | Department of Innovative Technology in Medicine and Dentistry | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Chieti- Department of Innovative Technology in Medicine and Dentistry | Chieti | Abruzzo | 66100 | Italy |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 5, 2021 | Aug 1, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D013281 | Stomatitis, Aphthous |
| D014456 | Ulcer |
| ID | Term |
|---|---|
| D013280 | Stomatitis |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D010335 | Pathologic Processes |
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| Device |
Placebo mouthwash |
|
| D013568 |
| Pathological Conditions, Signs and Symptoms |