Recurrent Aphthous StomatitisNCT07853326
Sesame Paste for Recurrent Aphthous Stomatitis
A study testing Sesame paste in people with Recurrent Aphthous Stomatitis, run by Ayat Gamal-AbdelNaser.
Trial summary
Oral recurrent aphthous stomatitis is a painful oral condition that affects large number of patients. In the Middle East, patients tend to commonly manage it by sesame paste. So, this study aims to test if sesame paste has any medical value compared to placebo. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Recurrent Aphthous Stomatitis
- What is being tested?
- Sesame paste
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- No sites listed yet
- Study dates
- Dec 2026to Dec 2028
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adult patients; diagnosed with having episodes of minor recurrent aphthous stomatitis around the age of puberty.
- the current episode of 1 to 3 simultaneous RAS lesions must have started for less than 24 hours.
Who cannot join
- patients who have any systemic disease or any extraoral lesions or manifestations.
- receiving any systemic medications in general, receiving analgesic mouthwash or systemic analgesic before 24 hours of starting the study.
- patients having allergy to sesame
About this study
Official title: Sesame Paste in the Management of Recurrent Aphthous Stomatitis: a Randomized Controlled Trial.
Oral recurrent aphthous stomatitis is a painful oral condition that affects large number of patients. In the Middle East, patients tend to commonly manage it by sesame paste. So, this study aims to test if sesame paste has any medical value compared to placebo.
- Conditions
- Recurrent Aphthous Stomatitis
- Being tested
- Sesame paste, Placebo
- Medical subject headings
- Stomatitis, Aphthous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sesame pasteDietary supplement
Sesame paste is available in grocery markets as "Tahina" or "Tahini"
PlaceboOther
placebo paste made to look, feel and smell like sesame paste
| Study group | Role | What they receive |
|---|---|---|
| Sesame paste | Active comparator | Not described Receives: Dietary Supplement: Sesame paste |
| Placebo paste | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain due to the oral ulcer
measured by VAS
Measured: 7 days
Secondary outcomes (1)
Size of the ulcer
measured in mm.s
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2026
- Study startDec 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2028 (estimated)
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.
- 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
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ayat Gamal-AbdelNaser
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ayat Gamal-AbdelNaser, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07853326
- Sponsor's protocol ID
- ACU-Med.6
- Status last verified
- Sep 2026
- First submitted
- 26 Sep 2026
- Last updated
- 1 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sesame Paste in the Management of Recurrent Aphthous Stomatitis: a Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT07853326
- Acronym / sponsor ID
- ACU-Med.6
- Conditions
- Recurrent Aphthous Stomatitis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Ayat Gamal-AbdelNaserUniversity, hospital or other
- Study start
- Dec 2026 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 1 Oct 2026 (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 recurrent aphthous stomatitis is a painful oral condition that affects large number of patients. In the Middle East, patients tend to commonly manage it by sesame paste. So, this study aims to test if sesame paste has any medical value compared to placebo.
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 |
|---|---|---|
| Sesame paste | Active comparator | Dietary Supplement: Sesame paste |
| Placebo paste | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- adult patients; diagnosed with having episodes of minor recurrent aphthous stomatitis around the age of puberty.
- the current episode of 1 to 3 simultaneous RAS lesions must have started for less than 24 hours.
Key exclusion criteria (3 listed)
- patients who have any systemic disease or any extraoral lesions or manifestations.
- receiving any systemic medications in general, receiving analgesic mouthwash or systemic analgesic before 24 hours of starting the study.
- patients having allergy to sesame
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 |
|---|---|---|
| Sesame pasteSesame paste is available in grocery markets as "Tahina" or "Tahini" | Dietary supplement | Sesame paste |
| Placeboplacebo paste made to look, feel and smell like sesame paste | Other | Placebo paste |
Primary outcome
Pain due to the oral ulcer
Time frame: 7 days
measured by VAS
1 secondary outcome
Size of the ulcer
Time frame: 7 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 1 Oct 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Sesame paste in people with Recurrent Aphthous Stomatitis, run by Ayat Gamal-AbdelNaser.
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 3 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: opening soon, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
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 due to the oral ulcer (time frame: 7 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 1 Oct 2026.