Recurrent Aphthous StomatitisPhase 3NCT04265001
Topical Hyaluronic Acid and Recurrent Aphthous Stomatitis.
A Phase 3 study testing Hyaluronic acid in the form of hyaluronan sodium 25 mg/100 ml as a mouthwash in people with Recurrent Aphthous Stomatitis, run by Cairo University at 1 site in Egypt.
Trial summary
This study was conducted to estimate the hypothesis that the topical hyaluronic acid mouthwash have no role in the treatment of recurrent aphthous stomatitis Read more about this study
- Who is it for?
- Ages 18 to 30 years
- Conditions the study is for
- Recurrent Aphthous Stomatitis
- What is being tested?
- Hyaluronic acid in the form of hyaluronan sodium 25 mg/100 ml as a mouthwash
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2019to 20 Jan 2020
- Phase
- Phase 3
- 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 30 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- The inclusion criteria were as follows:
- Age 18-30 years.
- Minimum of 2 years of RAS history, with active ulcer less than 48 hours of recurrent aphthous stomatitis.
Who cannot join
- known history of hypersensitivities to Chlorhexidine or hyaluronic acid.
- Use of any medication as a treatment for the present active ulcer.
- Smoking and presence of systemic diseases such as Behçet disease, anemia, Crohn's disease, ulcerative colitis, acquired immune deficiency syndrome, and liver or kidney disease.
- Pregnant or breast-feeding women.
- Stomach ulcer, duodenal ulcer, and inflammation of the stomach or the esophagus.
- Treatment with systemic nonsteroidal anti-inflammatory drugs, systemic steroids or other immune modulatory agents, oral antihistamines, or systemic antibiotics in the previous 3 months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Topical Hyaluronic Acid Versus Chlorhexidine Mouthwashes in the Treatment of Recurrent Aphthous Stomatitis: A Randomized Clinical Trial
This study was conducted to estimate the hypothesis that the topical hyaluronic acid mouthwash have no role in the treatment of recurrent aphthous stomatitis
Read the detailed description
Recurrent aphthous stomatitis (RAS) is a common and widely recognized disorder involving the oral mucosa. It occurs typically as a single or multiple well-defined painful self-limiting ulcerative lesions influencing the nonkeratinized oral mucous membrane surrounded by red halo. The prevalence of RAS is up to 25% in the world population, with recurrence rate of 50% every 3 mouths. The exact cause of RAS is uncertain, and accordingly numerous components are as yet being implicated such as genetic, hormonal, traumatic, nutritional, allergic, immunological, and psychological factors.
- Conditions
- Recurrent Aphthous Stomatitis
- Being tested
- Hyaluronic acid in the form of hyaluronan sodium 25 mg/100 ml as a mouthwash
- Keywords
- recurrent aphthous stomatitis, chlorhexidine, hyaluronic acid, pain, topical
- Medical subject headings
- Stomatitis, Aphthous, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyaluronic acid in the form of hyaluronan sodium 25 mg/100 ml as a mouthwashDrug
Also called (Aftamed; Bioplaxpharma, UK)
Topical mouthwash used three times daily for one week and patients were not allowed to eat or drink for one hour after rinsing.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | Topical cholrhexidine hydrochloride 125 mg/100 ml available commercially (Hexitol; Arab Drug Company for Pharmaceutical and Chemical Industries, Cairo, Egypt) mouthwash. Topical cholrhexidine hydrochloride mouthwash treatment has been repeated three times per day for one week. Receives: Drug: Hyaluronic acid in the form of hyaluronan sodium 25 mg/100 ml as a mouthwash |
| Hyaluronic acid group (HA group) | Experimental | Topical hyaluronic acid in the form of hyaluronan sodium 25 mg/100 ml as a mouthwash (Aftamed; Bioplaxpharma, UK).Topical hyaluronic acid mouthwash treatment has been repeated three times per day for one week. Receives: Drug: Hyaluronic acid in the form of hyaluronan sodium 25 mg/100 ml as a mouthwash |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain score
Pain assessment scale, visual analog scale (VAS) comprising of a 10-cm straight line among ends, with 0 representing no pain (better outcome) and 10 for intolerable pain (worse outcome) after irritation of the ulcer with the periodontal probe.
Measured: one week
Secondary outcomes (2)
Ulcer size
The ulcer size was evaluated by determining the distance between two opposed boundaries of the ulcer edge, using a periodontal probe in millimeters.Score for clinical improvement of the sign where high values indicate worse outcome but low values indicate better outcome.
Measured: one week
Duration of healing
period of the ulceration for complete healing
Measured: one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2020
- Study start1 Nov 2019
- Primary completion20 Jan 2020
- Study completion20 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Aphthous StomatitisStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mai Zakaria Ibrahium Mohammed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04265001
- Sponsor's protocol ID
- Mai Zakaria Ibrahium
- Status last verified
- Feb 2020
- First submitted
- 9 Feb 2020
- Last updated
- 11 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Because the research not published yet.
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Topical Hyaluronic Acid Versus Chlorhexidine Mouthwashes in the Treatment of Recurrent Aphthous Stomatitis: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04265001
- Acronym / sponsor ID
- Mai Zakaria Ibrahium
- Conditions
- Recurrent Aphthous Stomatitis
- Keywords
- recurrent aphthous stomatitis, chlorhexidine, hyaluronic acid, pain, topical
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 20 Jan 2020 (actual)
- Study completion
- 20 Jan 2020 (actual)
- First posted
- 11 Feb 2020 (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.
This study was conducted to estimate the hypothesis that the topical hyaluronic acid mouthwash have no role in the treatment of recurrent aphthous stomatitis
Detailed description
Recurrent aphthous stomatitis (RAS) is a common and widely recognized disorder involving the oral mucosa. It occurs typically as a single or multiple well-defined painful self-limiting ulcerative lesions influencing the nonkeratinized oral mucous membrane surrounded by red halo. The prevalence of RAS is up to 25% in the world population, with recurrence rate of 50% every 3 mouths. The exact cause of RAS is uncertain, and accordingly numerous components are as yet being implicated such as genetic, hormonal, traumatic, nutritional, allergic, immunological, and psychological factors.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Drug: Hyaluronic acid in the form of hyaluronan sodium 25 mg/100 ml as a mouthwashTopical cholrhexidine hydrochloride 125 mg/100 ml available commercially (Hexitol; Arab Drug Company for Pharmaceutical and Chemical Industries, Cairo, Egypt) mouthwash. Topical cholrhexidine hydrochloride mouthwash treatment has been repeated three times per day for one week. |
| Hyaluronic acid group (HA group) | Experimental | Drug: Hyaluronic acid in the form of hyaluronan sodium 25 mg/100 ml as a mouthwashTopical hyaluronic acid in the form of hyaluronan sodium 25 mg/100 ml as a mouthwash (Aftamed; Bioplaxpharma, UK).Topical hyaluronic acid mouthwash treatment has been repeated three times per day for one week. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age 18-30 years.
- Minimum of 2 years of RAS history, with active ulcer less than 48 hours of recurrent aphthous stomatitis.
Key exclusion criteria (6 listed)
- known history of hypersensitivities to Chlorhexidine or hyaluronic acid.
- Use of any medication as a treatment for the present active ulcer.
- Smoking and presence of systemic diseases such as Behçet disease, anemia, Crohn's disease, ulcerative colitis, acquired immune deficiency syndrome, and liver or kidney disease.
- Pregnant or breast-feeding women.
- Stomach ulcer, duodenal ulcer, and inflammation of the stomach or the esophagus.
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 in the form of hyaluronan sodium 25 mg/100 ml as a mouthwashAlso: (Aftamed; Bioplaxpharma, UK)Topical mouthwash used three times daily for one week and patients were not allowed to eat or drink for one hour after rinsing. | Drug | Control group, Hyaluronic acid group (HA group) |
Primary outcome
Pain score
Time frame: one week
Pain assessment scale, visual analog scale (VAS) comprising of a 10-cm straight line among ends, with 0 representing no pain (better outcome) and 10 for intolerable pain (worse outcome) after irritation of the ulcer with the periodontal probe.
2 secondary outcomes
Ulcer size
Time frame: one week
Duration of healing
Time frame: one week
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 11 Feb 2020.
- Individual participant dataSharing planned: No. Because the research not published yet.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Hyaluronic acid in the form of hyaluronan sodium 25 mg/100 ml as a mouthwash in people with Recurrent Aphthous Stomatitis, run by Cairo University at 1 site in Egypt.
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 3 inclusion and 6 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 11 Feb 2020. 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 Egypt. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 score (time frame: one week). 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 11 Feb 2020.