Recurrent Aphthous UlcerRASMANCT07121361
Effectiveness of Recurrent Aphthous Stomatitis Mouthwash System for the Treatment of Oral Ulcers
A study testing Mouthwash Product in people with Recurrent Aphthous Ulcer and Recurrent Aphthous Stomatitis, run by G. d'Annunzio University at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Recurrent Aphthous Ulcer, Recurrent Aphthous Stomatitis
- What is being tested?
- Mouthwash Product
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- 28 Nov 2023to 24 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients with at least one well-defined oral ulcer.
- Patients with no cognitive disorders able to provide mouthwash treatment independently
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Italy1 site
University of Chieti- Department of Innovative Technology in Medicine and Dentistry
Chieti, Abruzzo, 66100
About this study
Official title: Evaluation of the Efficacy of a Mouthwash Formulation for Minor Oral Ulcers: A Triple-Blind Randomized Controlled Trial
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.
Read the 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:
- Registration of the superficial temperature of the mucous membranes using Infrared Thermography.
- Ulcer Severity Score (USS).
- Being tested
- Mouthwash Product, Control
- Keywords
- Ulcers, Oral Hygiene, Oral care
- Medical subject headings
- Stomatitis, Aphthous, Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mouthwash ProductDevice
DNA mouthwash
ControlDevice
Placebo mouthwash
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: Mouthwash Product |
| 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 Receives: Device: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2025
- Study start28 Nov 2023
- Primary completion10 Jan 2024
- Study completion24 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Aphthous UlcerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- G. d'Annunzio University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Felice Lorusso, G. d'Annunzio University
- Investigators
- Prof. Antonio Scarano Antonio Scarano, MD DDS, Study director, Department of Innovative Technology in Medicine and Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07121361
- Sponsor's protocol ID
- RA/0362820
- Other IDs
- RA/0362820
- Acronym
- RASMA
- Status last verified
- Aug 2025
- First submitted
- 1 Aug 2025
- Last updated
- 13 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy of a Mouthwash Formulation for Minor Oral Ulcers: A Triple-Blind Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07121361
- Acronym / sponsor ID
- RASMA / RA/0362820
- Keywords
- Ulcers, Oral Hygiene, Oral care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- G. d'Annunzio UniversityUniversity, hospital or other
- Study start
- 28 Nov 2023 (actual)
- Primary completion
- 10 Jan 2024 (actual)
- Study completion
- 24 Feb 2024 (actual)
- First posted
- 13 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Registration of the superficial temperature of the mucous membranes using Infrared Thermography.
- Ulcer Severity Score (USS).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DNA mouthwash | Active comparator | Device: Mouthwash ProductThe 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 | Device: ControlThe 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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with at least one well-defined oral ulcer.
- Patients with no cognitive disorders able to provide mouthwash treatment independently
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mouthwash ProductDNA mouthwash | Device | DNA mouthwash |
| ControlPlacebo mouthwash | Device | Placebo mouthwash |
Primary outcome
Pain intensity
Time frame: 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
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Prof. Antonio Scarano Antonio Scarano, MD DDS study director
Department of Innovative Technology in Medicine and Dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mouthwash Product in people with Recurrent Aphthous Ulcer and Recurrent Aphthous Stomatitis, run by G. d'Annunzio University at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity (time frame: 14 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2025.