Aphthus UlcerPhase 2/3NCT06910579
Oxygenated Gel Therapy in the Management of Oral Aphthous Ulcers
A Phase 2/3 study testing topical application of oxygenated gel and topical application of Triamcinolone acetonide gel in people with Aphthus Ulcer, run by British University In Egypt at 1 site in Egypt.
Trial summary
Interventions of both groups: Oxygenated gel Group: 15 patients who used oxygenated gel (Blue®m, Wijhe, Netherlands) were trained by the co-investigator (A.H) through real demonstration for topical application of the gel on aphthous ulcers, which entails the application of 1-2 ml of oxygenated gel directly to the… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Aphthus Ulcer
- What is being tested?
- topical application of oxygenated gel and topical application of Triamcinolone acetonide gel
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Mar 2025to 12 Jul 2027
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Clinically diagnosed patients with chronic aphthous stomatitis measuring ≤6 mm in size in the oral cavity and who gave written consent for participation.
- Only single ulcers were considered for the study.
- Systemically healthy patients.
Who cannot join
- The study excluded patients with a history of associated systemic disease.
- Cases of chronic aphthous stomatitis (major), lesions of herpetic form, numerous aphthae, and smoking.
- Patients with a history of hypersensitivity to the used agents.
- Pregnancy and lactation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
British University in Egypt
Al Sherouk City, Cairo Governorate, 11837
ahmed hamdy, phd, +201061112512, ahmed.esmaail@bue.edu.eg
Hamdy
About this study
Official title: Efficacy of Oxygenated Gel Therapy in the Management of Oral Aphthous Ulcers: A Randomized Controlled Clinical Trial
Interventions of both groups:
Oxygenated gel Group: 15 patients who used oxygenated gel (Blue®m, Wijhe, Netherlands) were trained by the co-investigator (A.H) through real demonstration for topical application of the gel on aphthous ulcers, which entails the application of 1-2 ml of oxygenated gel directly to the ulcer two times per day and this was repeated for 7 days.
Read more
Triamcinolone acetonide Group: 15 patients were treated with Kenalog in orabase (Triamcinolone acetonide 0.1% oral paste 5g), four times (i.e., at 8 am, 12 noon, 4 pm, and 8 pm) a day for 7 days at intervention group.
Patients in both groups were reexamined after treatment at different intervals (day 3, day 5, day 7, and day 10).
- Conditions
- Aphthus Ulcer
- Being tested
- topical application of oxygenated gel, topical application of Triamcinolone acetonide gel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
topical application of oxygenated gelDrug
patients who used oxygenated gel (Blue®m, Wijhe, Netherlands) were trained by the co-investigator (A.H) through real demonstration for topical application of the gel on aphthous ulcers, which entails the application of 1-2 ml of oxygenated gel directly to the ulcer two times per day and this was repeated for 7 days
topical application of Triamcinolone acetonide gelDrug
patients were treated with Kenalog in orabase (Triamcinolone acetonide 0.1% oral paste 5g), four times (i.e., at 8 am, 12 noon, 4 pm, and 8 pm) a day for 7 days at intervention group.
| Study group | Role | What they receive |
|---|---|---|
| control | Active comparator | 15 patients were treated with Kenalog in orabase (Triamcinolone acetonide 0.1% oral paste 5g), four times (i.e., at 8 am, 12 noon, 4 pm, and 8 pm) a day for 7 days at intervention group. Receives: Drug: topical application of Triamcinolone acetonide gel |
| Oxygenated gel Group | Experimental | 15 patients who used oxygenated gel (Blue®m, Wijhe, Netherlands) were trained by the co-investigator (A.H) through real demonstration for topical application of the gel on aphthous ulcers, which entails the application of 1-2 ml of oxygenated gel directly to the ulcer two times per day and this was repeated for 7 days Receives: Drug: topical application of oxygenated gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity
Visual Analog Scale (0-10), which measured a range of "no pain" to "unbearable pain" on a 100 mm horizontal line [10]. to determine the intensity of pain on day 0, day 3, day 5, day 7, and day 10
Measured: 10 days
Secondary outcomes (3)
Size of ulcers (in mm)
after starting treatment, ulcer size was recorded on day 0, day 3, day 5, day 7, and day 10 using a calibrated dental probe with millimeter marking
Measured: 10 days
Complete healing duration
the duration till complete healing is achieved is recorded in days
Measured: 10 days
OHIP-14
has been assessed 1 week after intervention. OHIP-14 utilizes a scale with five categories (1 = never, 2 = hardly ever, 3 = occasionally, 4 = fairly often, and 5 = very often). A lower score in any of the five categories indicates higher satisfaction
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2025
- Study start15 Mar 2025
- Primary completion30 Jan 2027 (estimated)
- Study completion12 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aphthus 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- British University In Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06910579
- Sponsor's protocol ID
- britishUE1
- Status last verified
- Apr 2026
- First submitted
- 28 Mar 2025
- Last updated
- 15 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all IPD that underlie results in a publication will be shared
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Oxygenated Gel Therapy in the Management of Oral Aphthous Ulcers: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06910579
- Acronym / sponsor ID
- britishUE1
- Conditions
- Aphthus Ulcer
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- British University In EgyptUniversity, hospital or other
- Study start
- 15 Mar 2025 (actual)
- Primary completion
- 30 Jan 2027 (estimated)
- Study completion
- 12 Jul 2027 (estimated)
- First posted
- 4 Apr 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.
Interventions of both groups:
Oxygenated gel Group: 15 patients who used oxygenated gel (Blue®m, Wijhe, Netherlands) were trained by the co-investigator (A.H) through real demonstration for topical application of the gel on aphthous ulcers, which entails the application of 1-2 ml of oxygenated gel directly to the ulcer two times per day and this was repeated for 7 days.
Triamcinolone acetonide Group: 15 patients were treated with Kenalog in orabase (Triamcinolone acetonide 0.1% oral paste 5g), four times (i.e., at 8 am, 12 noon, 4 pm, and 8 pm) a day for 7 days at intervention group.
Patients in both groups were reexamined after treatment at different intervals (day 3, day 5, day 7, and day 10).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control | Active comparator | Drug: topical application of Triamcinolone acetonide gel15 patients were treated with Kenalog in orabase (Triamcinolone acetonide 0.1% oral paste 5g), four times (i.e., at 8 am, 12 noon, 4 pm, and 8 pm) a day for 7 days at intervention group. |
| Oxygenated gel Group | Experimental | Drug: topical application of oxygenated gel15 patients who used oxygenated gel (Blue®m, Wijhe, Netherlands) were trained by the co-investigator (A.H) through real demonstration for topical application of the gel on aphthous ulcers, which entails the application of 1-2 ml of oxygenated gel directly to the ulcer two times per day and this was repeated for 7 days |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Clinically diagnosed patients with chronic aphthous stomatitis measuring ≤6 mm in size in the oral cavity and who gave written consent for participation.
- Only single ulcers were considered for the study.
- Systemically healthy patients.
Key exclusion criteria (4 listed)
- The study excluded patients with a history of associated systemic disease.
- Cases of chronic aphthous stomatitis (major), lesions of herpetic form, numerous aphthae, and smoking.
- Patients with a history of hypersensitivity to the used agents.
- Pregnancy and lactation
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 |
|---|---|---|
| topical application of oxygenated gelpatients who used oxygenated gel (Blue®m, Wijhe, Netherlands) were trained by the co-investigator (A.H) through real demonstration for topical application of the gel on aphthous ulcers, which entails the application of 1-2 ml of oxygenated gel directly to the ulcer two times per day and this was repeated for 7 days | Drug | Oxygenated gel Group |
| topical application of Triamcinolone acetonide gelpatients were treated with Kenalog in orabase (Triamcinolone acetonide 0.1% oral paste 5g), four times (i.e., at 8 am, 12 noon, 4 pm, and 8 pm) a day for 7 days at intervention group. | Drug | control |
Primary outcome
Pain intensity
Time frame: 10 days
Visual Analog Scale (0-10), which measured a range of "no pain" to "unbearable pain" on a 100 mm horizontal line [10]. to determine the intensity of pain on day 0, day 3, day 5, day 7, and day 10
3 secondary outcomes
Size of ulcers (in mm)
Time frame: 10 days
Complete healing duration
Time frame: 10 days
OHIP-14
Time frame: 10 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- Individual participant dataSharing planned: Yes. all IPD that underlie results in a publication will be shared
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing topical application of oxygenated gel and topical application of Triamcinolone acetonide gel in people with Aphthus Ulcer, run by British University In Egypt 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 4 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: looking for participants now, as of the sponsor's last update on 15 Oct 2026. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity (time frame: 10 days). 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 15 Oct 2026.