Aphthous Stomatitis, RecurrentEarly Phase 1NCT06960278
Effect of Alum Stone Containing Mucosal Adhesive Patches on Healing of Recurrent Aphthous Stomatitis
A Early Phase 1 study testing Size of aphthous lesions and degree of pain assessed at days 1, 3, and 5. and ALUMSTONE in people with Aphthous Stomatitis, Recurrent and Aphthous Stomatitis, run by University Of Anbar at 1 site in Iraq.
Trial summary
The evaluation of recurrent aphthous stomatitis (RAS) was performed by an oral medicine specialist, who relied on the clinical manifestations of the condition. The experimental group was administered 1x1cm mucosal patches containing alum stone at a concentration of 7%, whereas the control group was given placebo… Read more about this study
- Who is it for?
- Ages 22 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Aphthous Stomatitis, Recurrent, Aphthous Stomatitis, Aphthous Ulcer
- What is being tested?
- Size of aphthous lesions and degree of pain assessed at days 1, 3, and 5. and ALUMSTONE
- Type of treatment
- Pill or oral medicine, Medical device, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteIraq
- Study dates
- 5 Feb 2021to 2 Mar 2023
- Phase
- Early Phase 1
- 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 22 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Inclusion Criteria: individuals who had a history of RAS, with oral ulceration occurring at least once a month and persistent oral ulceration being present in the majority of patients. Additionally, individuals with mild aphthous ulcer, characterized by ulcer development lasting fewer than three days, were also included.
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Exclusion Criteria: Exclusion criteria encompassed the following: Pregnancy or lactation, systemic disorders linked to aphthous ulcers, such as Crohn's disease, Reiter's syndrome, and people who smoke or use cigarettes. Participants who were getting pharmacological therapy for fungal or viral infections, as well as those who were taking non-steroidal anti-inflammatory drugs, subjects with recent oral surgery, and those with fixed orthodontic appliances or retainers near the ulcer were not recruited for the study
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Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Alum Stone Containing Mucosal Adhesive Patches on Healing of Recurrent Aphthous Stomatitis: A Randomized Double-blinded Placebo-controlled Clinical Trial
The evaluation of recurrent aphthous stomatitis (RAS) was performed by an oral medicine specialist, who relied on the clinical manifestations of the condition. The experimental group was administered 1x1cm mucosal patches containing alum stone at a concentration of 7%, whereas the control group was given placebo patches without any active medication. Size of aphthous lesions and degree of pain assessed at days 1, 3, and 5. Statistical analysis was performed with repeated measures ANOVA using R software.
Read the detailed description
The study's results indicated that the utilization of alum stone in mucosal adhesive patches yielded significant reductions in size of aphthous lesions and degree of pain.
- Being tested
- Size of aphthous lesions and degree of pain assessed at days 1, 3, and 5., Control, ALUMSTONE
- Keywords
- Alum stone, aphthous ulcer, mucosal adhesive patches
- Medical subject headings
- Sutton disease 2, Stomatitis, Aphthous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Size of aphthous lesions and degree of pain assessed at days 1, 3, and 5.Procedure or surgery
Size of aphthous lesions and degree of pain assessed at days 1, 3, and 5.
ControlProcedure or surgery
The dimensions of the lesion were measured by oral medicine specialists using a flexible ruler
ALUMSTONEDevice
alum administration via adhesive patches on the healing process of aphthous ulcers
| Study group | Role | What they receive |
|---|---|---|
| A Randomized Double-blinded Placebo-controlled Clinical Trial | Placebo comparator | The experimental group was administered 1x1cm mucosal patches containing alum stone at a concentration of 7%, whereas the control group was given placebo patches without any active medication Receives: Procedure: Size of aphthous lesions and degree of pain assessed at days 1, 3, and 5.; Procedure: Control |
| Control | Experimental | Not described Receives: Procedure: Size of aphthous lesions and degree of pain assessed at days 1, 3, and 5.; Procedure: Control |
| Placebo | Placebo comparator | hundred female from the patients of oral diagnosis clinic in college of dentistry and from the privet clinic Receives: Device: ALUMSTONE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lesion Size
Measured: 1, 3, 5 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2025
- Study start5 Feb 2021
- Primary completion15 Oct 2022
- Study completion2 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aphthous Stomatitis, RecurrentStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- In this study one hundred female, aged between twenty-two and thirty years, reported multiple oral aphthous ulcers. The evaluation of recurrent aphthous stomatitis (RAS) was performed by an oral medicine specialist, who relied on the clinical manifestations of the condition. The experimental group was administered 1x1cm mucosal patches containing alum stone at a concentration of 7%, whereas the control group was given placebo patches without any active medication. Size of aphthous lesions and degree of pain assessed at days 1, 3, and 5. Statistical analysis was performed with repeated measures ANOVA using R software
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Of Anbar
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marwan Mahmood Saleh, University Of Anbar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06960278
- Sponsor's protocol ID
- UAnbar
- Status last verified
- Apr 2025
- First submitted
- 15 Feb 2025
- Last updated
- 7 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Alum Stone Containing Mucosal Adhesive Patches on Healing of Recurrent Aphthous Stomatitis: A Randomized Double-blinded Placebo-controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06960278
- Acronym / sponsor ID
- UAnbar
- Keywords
- Alum stone, aphthous ulcer, mucosal adhesive patches
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University Of AnbarUniversity, hospital or other
- Study start
- 5 Feb 2021 (actual)
- Primary completion
- 15 Oct 2022 (actual)
- Study completion
- 2 Mar 2023 (actual)
- First posted
- 7 May 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 evaluation of recurrent aphthous stomatitis (RAS) was performed by an oral medicine specialist, who relied on the clinical manifestations of the condition. The experimental group was administered 1x1cm mucosal patches containing alum stone at a concentration of 7%, whereas the control group was given placebo patches without any active medication. Size of aphthous lesions and degree of pain assessed at days 1, 3, and 5. Statistical analysis was performed with repeated measures ANOVA using R software.
Detailed description
The study's results indicated that the utilization of alum stone in mucosal adhesive patches yielded significant reductions in size of aphthous lesions and degree of pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- In this study one hundred female, aged between twenty-two and thirty years, reported multiple oral aphthous ulcers. The evaluation of recurrent aphthous stomatitis (RAS) was performed by an oral medicine specialist, who relied on the clinical manifestations of the condition. The experimental group was administered 1x1cm mucosal patches containing alum stone at a concentration of 7%, whereas the control group was given placebo patches without any active medication. Size of aphthous lesions and degree of pain assessed at days 1, 3, and 5. Statistical analysis was performed with repeated measures ANOVA using R software
| Arm | Type | Receives |
|---|---|---|
| A Randomized Double-blinded Placebo-controlled Clinical Trial | Placebo comparator | Procedure: Size of aphthous lesions and degree of pain assessed at days 1, 3, and 5., Procedure: ControlThe experimental group was administered 1x1cm mucosal patches containing alum stone at a concentration of 7%, whereas the control group was given placebo patches without any active medication |
| Control | Experimental | Procedure: Size of aphthous lesions and degree of pain assessed at days 1, 3, and 5., Procedure: Control |
| Placebo | Placebo comparator | Device: ALUMSTONEhundred female from the patients of oral diagnosis clinic in college of dentistry and from the privet clinic |
Who may qualify
- Ages
- 22 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
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 |
|---|---|---|
| Size of aphthous lesions and degree of pain assessed at days 1, 3, and 5.Size of aphthous lesions and degree of pain assessed at days 1, 3, and 5. | Procedure or surgery | A Randomized Double-blinded Placebo-controlled Clinical Trial, Control |
| ControlThe dimensions of the lesion were measured by oral medicine specialists using a flexible ruler | Procedure or surgery | A Randomized Double-blinded Placebo-controlled Clinical Trial, Control |
| ALUMSTONEalum administration via adhesive patches on the healing process of aphthous ulcers | Device | Placebo |
Primary outcome
Lesion Size
Time frame: 1, 3, 5 day
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 7 May 2025.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
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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 Early Phase 1 study testing Size of aphthous lesions and degree of pain assessed at days 1, 3, and 5. and ALUMSTONE in people with Aphthous Stomatitis, Recurrent and Aphthous Stomatitis, run by University Of Anbar at 1 site in Iraq.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 7 May 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 Iraq. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
Lesion Size (time frame: 1, 3, 5 day). 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 7 May 2025.