Aphthous StomatitisNCT04884464
Hyaluronic Acid in Counteracting Aphthous Stomatitis
An observational study of Aphthous Stomatitis, run by University of Urbino "Carlo Bo" at 1 site in Italy.
Trial summary
Oral mucosal ulcers can determine a real worsening of the quality of life. Conventional therapy usually lasts not less than 2-3 weeks, and carries a high risk of serious side effects; furthermore, ulcers often recur. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Aphthous Stomatitis
- What is being tested?
- Hyaluronic acid-based gel and Chlorhexidine Gluconate
- Type of treatment
- Medical device
- How many people
- 49 participants
- Where
- 1 siteItaly
- Study dates
- 1 Sep 2018to 30 Jun 2019
- Phase
- Observational
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult subjects without ethnic limitations, of both sexes and between the ages of 18 and 65, with a diagnosis of aphthous stomatitis, but considered otherwise healthy.
Who may be able to join
- Diagnosis of aphthous stomatitis
- Healthy for other conditions excluding aphthous stomatitis
Who cannot join
- Taking one of the following in the 45 days prior to the beginning of the study: immunosuppressive, cytotoxic, cortisone, antibiotic, antifungal, hormone therapy (including birth control pills).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Evaluation of a Hyaluronic Acid-based Medical Device in Counteracting Aphthous Stomatitis in Adults
Oral mucosal ulcers can determine a real worsening of the quality of life. Conventional therapy usually lasts not less than 2-3 weeks, and carries a high risk of serious side effects; furthermore, ulcers often recur. The use of hyaluronic acid applied as an adhesive gel over the lesions seems to have potential in terms of efficacy and the avoidance of side effects. Of course, hyaluronic acid-based formulations show different effects and tolerability. In this retrospective observational study, the results obtained using a hyaluronic-acid based medical device applied for 14 days to counteract ulcers in adults will be reported.
- Conditions
- Aphthous Stomatitis
- Being tested
- Hyaluronic acid-based gel, Chlorhexidine Gluconate
- Keywords
- mucositis, oral ulcers, chlorhexidine, aloe barbadensis, rosa damascena
- Medical subject headings
- Stomatitis, Aphthous, Mucositis, Oral Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyaluronic acid-based gelDevice
Dosage: application of an even coat of 1mm thickness Frequency: 3 times/day (after main meals) Duration: 2 weeks
Chlorhexidine GluconateDrug
Dosage: application of an even coat of 1mm thickness Frequency: 3 times/day (after main meals) Duration: 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| Hyaluronic acid-based gel | The composition of the gel, ranked by weight is: xylitol, glycerin, Rosa damascena petal extract, xanthan gum, polycarbophil, hyaluronic acid sodium salt (0.24%), pectin, potassium sorbate, sodium benzoate, panthenol, Aloe barbadensis leaf extract, stevia. Receives: Device: Hyaluronic acid-based gel | |
| Chlorhexidine gluconate | Chlorhexidine gluconate at a concentration of 0.2%. Receives: Drug: Chlorhexidine Gluconate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in number of oral lesions
Change from baseline (Day 1) to Day 14 in the number of oral lesions observed in the two groups
Measured: Day 1; Day 3; Day 6; Day 9; Day 12; Day 14
Change in size of oral lesions
Change from baseline (Day 1) to Day 14 in the size (mm) of oral lesions observed in the two groups
Measured: Day 1; Day 3; Day 6; Day 9; Day 12; Day 14
Secondary outcomes (2)
Compliance to treatment
Number of daily treatments completed, timing of treatment application (hour of the day)
Measured: From Day 1 to Day 14
Side effects to treatment
Dosage Record Treatment Emergent Symptom Scale (DOTES). It uses a Likert scale, going from 1 (no side effects) to 4 (severe side effects).
Measured: From Day 1 to Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2021
- Study start1 Sep 2018
- Primary completion30 Jun 2019
- Study completion30 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aphthous StomatitisStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Urbino "Carlo Bo"
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Davide Sisti, University of Urbino "Carlo Bo"
- Investigators
- Davide Sisti, PhD, Principal investigator, University of Urbino "Carlo Bo"
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04884464
- Sponsor's protocol ID
- UniUrb_HyalAcid_2021
- Status last verified
- Jul 2021
- First submitted
- 4 May 2021
- Last updated
- 22 Jul 2021
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of a Hyaluronic Acid-based Medical Device in Counteracting Aphthous Stomatitis in Adults
- ClinicalTrials.gov ID
- NCT04884464
- Acronym / sponsor ID
- UniUrb_HyalAcid_2021
- Conditions
- Aphthous Stomatitis
- Keywords
- mucositis, oral ulcers, chlorhexidine, aloe barbadensis, rosa damascena
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- University of Urbino "Carlo Bo"University, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 13 May 2021 (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.
Oral mucosal ulcers can determine a real worsening of the quality of life. Conventional therapy usually lasts not less than 2-3 weeks, and carries a high risk of serious side effects; furthermore, ulcers often recur. The use of hyaluronic acid applied as an adhesive gel over the lesions seems to have potential in terms of efficacy and the avoidance of side effects. Of course, hyaluronic acid-based formulations show different effects and tolerability. In this retrospective observational study, the results obtained using a hyaluronic-acid based medical device applied for 14 days to counteract ulcers in adults will be reported.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hyaluronic acid-based gel | – | Device: Hyaluronic acid-based gelThe composition of the gel, ranked by weight is: xylitol, glycerin, Rosa damascena petal extract, xanthan gum, polycarbophil, hyaluronic acid sodium salt (0.24%), pectin, potassium sorbate, sodium benzoate, panthenol, Aloe barbadensis leaf extract, stevia. |
| Chlorhexidine gluconate | – | Drug: Chlorhexidine GluconateChlorhexidine gluconate at a concentration of 0.2%. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult subjects without ethnic limitations, of both sexes and between the ages of 18 and 65, with a diagnosis of aphthous stomatitis, but considered otherwise healthy.
Key inclusion criteria (2 listed)
- Diagnosis of aphthous stomatitis
- Healthy for other conditions excluding aphthous stomatitis
Key exclusion criteria (1 listed)
- Taking one of the following in the 45 days prior to the beginning of the study: immunosuppressive, cytotoxic, cortisone, antibiotic, antifungal, hormone therapy (including birth control pills).
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 |
|---|---|---|
| Hyaluronic acid-based gelDosage: application of an even coat of 1mm thickness Frequency: 3 times/day (after main meals) Duration: 2 weeks | Device | Hyaluronic acid-based gel |
| Chlorhexidine GluconateDosage: application of an even coat of 1mm thickness Frequency: 3 times/day (after main meals) Duration: 2 weeks | Drug | Chlorhexidine gluconate |
Primary outcome
Change in number of oral lesions
Time frame: Day 1; Day 3; Day 6; Day 9; Day 12; Day 14
Change from baseline (Day 1) to Day 14 in the number of oral lesions observed in the two groups
Change in size of oral lesions
Time frame: Day 1; Day 3; Day 6; Day 9; Day 12; Day 14
Change from baseline (Day 1) to Day 14 in the size (mm) of oral lesions observed in the two groups
2 secondary outcomes
Compliance to treatment
Time frame: From Day 1 to Day 14
Side effects to treatment
Time frame: From Day 1 to Day 14
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 22 Jul 2021.
- Individual participant dataSharing planned: No
Related trials for Aphthous Stomatitis
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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.
Davide Sisti, PhD principal investigator
University of Urbino "Carlo Bo"
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aphthous Stomatitis, run by University of Urbino "Carlo Bo" 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 1 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 22 Jul 2021. 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. 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?
Change in number of oral lesions (time frame: Day 1; Day 3; Day 6; Day 9; Day 12; Day 14). 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 22 Jul 2021.