Recurrent Aphthous StomatitisPhase 2NCT07702474
Efficacy of 5% Chitosan Nanoparticle Paste in the Treatment of Recurrent Aphthous Stomatitis
A Phase 2 study testing Triamcinolone Acetonide 0.1% Oral Paste and 5 wt.% Chitosan Nanoparticle Paste in people with Recurrent Aphthous Stomatitis and Oral Ulcers, run by Kerman University of Medical Sciences.
Trial summary
The purpose of this study is to evaluate the therapeutic clinical efficacy of a synthesized 5 wt.% chitosan nanoparticle paste compared to a standard topical corticosteroid (triamcinolone acetonide 0.1% oral paste) in patients suffering from minor recurrent aphthous stomatitis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Recurrent Aphthous Stomatitis, Oral Ulcers
- What is being tested?
- Triamcinolone Acetonide 0.1% Oral Paste and 5 wt.% Chitosan Nanoparticle Paste
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 21 Apr 2009to 1 Dec 2009
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients complaining of oral recurrent ulcers with signs of minor recurrent aphthous stomatitis.
- History of oral recurrent ulcers with a recurrence rate of 2 to 3 times per year.
- Ulcer diameter less than 1 cm at baseline.
- Maximum of 4 days passed since the emergence of the current ulcer.
- No use of any prior medications or treatment for the current ulcer.
- Signed written informed consent.
Who cannot join
- Background of systemic diseases, including diabetes mellitus.
- Connective tissue diseases such as Lupus.
- Syndromes or diseases related to aphthous ulcers, such as cyclic neutropenia and Behcet's disease.
About this study
Official title: Wound Healing Effect of Chitosan Nanoparticles and Low Molecular Weight Chitosan: Animal and Clinical Studies
The purpose of this study is to evaluate the therapeutic clinical efficacy of a synthesized 5 wt.% chitosan nanoparticle paste compared to a standard topical corticosteroid (triamcinolone acetonide 0.1% oral paste) in patients suffering from minor recurrent aphthous stomatitis. The study specifically monitors changes in clinical ulcer diameter and pain reduction.
Read the detailed description
Recurrent aphthous stomatitis (RAS) is a common oral mucosal disease causing significant pain and discomfort. This randomized, active-controlled, single-blind clinical trial investigates a novel mucoadhesive 5 wt.% chitosan nanoparticle paste formulation synthesized via the ionic gelation technique. Eligible patients diagnosed with minor RAS are randomly allocated in a 1:1 ratio to either Group A (active control: triamcinolone acetonide 0.1% oral paste) or Group B (experimental: 5 wt.% chitosan nanoparticle paste). Both groups apply their designated medication topically four times a day using a sterile swab after rinsing and drying the affected area. Treatment is continued until complete healing of the ulcer occurs. Clinical follow-up examinations are performed periodically at days 0, 1, 6, and 10 to measure the clinical ulcer diameter using a Hu-Friedy periodontal probe and to record subjective pain scores via a Visual Analogue Scale (VAS).
- Conditions
- Recurrent Aphthous Stomatitis, Oral Ulcers
- Being tested
- Triamcinolone Acetonide 0.1% Oral Paste, 5 wt.% Chitosan Nanoparticle Paste
- Keywords
- Chitosan, Nanoparticles, Triamcinolone Acetonide, Aphthous Ulcers, Wound Healing
- Medical subject headings
- Stomatitis, Aphthous, Oral Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Triamcinolone Acetonide 0.1% Oral PasteDrug
Also called Adcortyl
Standard reference topical corticosteroid ointment utilized as the active standard of care control.
5 wt.% Chitosan Nanoparticle PasteDrug
Also called Chitosan Paste, CN
Synthesized via ionic gelation method using low molecular weight chitosan and sodium tripolyphosphate, formulated into a 5 wt.% mucoadhesive paste.
| Study group | Role | What they receive |
|---|---|---|
| Active Comparator: Triamcinolone Group | Active comparator | Patients received triamcinolone acetonide 0.1% oral paste (Adcortyl) applied topically 4 times a day until complete healing. Receives: Drug: Triamcinolone Acetonide 0.1% Oral Paste |
| Experimental: Chitosan Nanoparticle Group | Experimental | Patients received mucoadhesive 5 wt.% chitosan nanoparticle paste applied topically 4 times a day until complete healing. Receives: Drug: 5 wt.% Chitosan Nanoparticle Paste |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in clinical ulcer diameter
Measured in millimeters using a Hu-Friedy periodontal probe to evaluate clinical wound contraction and reduction in lesion size.
Measured: Days 0, 1, 6, and 10
Secondary outcomes (1)
Change in pain severity score
Subjective pain intensity recorded by patients using a Visual Analogue Scale (VAS) graded from 0 (no pain) to 10 (highest rate of pain).
Measured: Days 0, 1, 6, and 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2026
- Study start21 Apr 2009
- Primary completion3 Nov 2009
- Study completion1 Dec 2009
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kerman University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, zahra atai, Kerman University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07702474
- Sponsor's protocol ID
- IR.KMU.REC.1388.111
- Status last verified
- Jul 2026
- First submitted
- 9 Jul 2026
- Last updated
- 14 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Wound Healing Effect of Chitosan Nanoparticles and Low Molecular Weight Chitosan: Animal and Clinical Studies
- ClinicalTrials.gov ID
- NCT07702474
- Acronym / sponsor ID
- IR.KMU.REC.1388.111
- Conditions
- Recurrent Aphthous Stomatitis, Oral Ulcers
- Keywords
- Chitosan, Nanoparticles, Triamcinolone Acetonide, Aphthous Ulcers, Wound Healing
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Kerman University of Medical SciencesUniversity, hospital or other
- Study start
- 21 Apr 2009 (actual)
- Primary completion
- 3 Nov 2009 (actual)
- Study completion
- 1 Dec 2009 (actual)
- First posted
- 14 Jul 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.
The purpose of this study is to evaluate the therapeutic clinical efficacy of a synthesized 5 wt.% chitosan nanoparticle paste compared to a standard topical corticosteroid (triamcinolone acetonide 0.1% oral paste) in patients suffering from minor recurrent aphthous stomatitis. The study specifically monitors changes in clinical ulcer diameter and pain reduction.
Detailed description
Recurrent aphthous stomatitis (RAS) is a common oral mucosal disease causing significant pain and discomfort. This randomized, active-controlled, single-blind clinical trial investigates a novel mucoadhesive 5 wt.% chitosan nanoparticle paste formulation synthesized via the ionic gelation technique. Eligible patients diagnosed with minor RAS are randomly allocated in a 1:1 ratio to either Group A (active control: triamcinolone acetonide 0.1% oral paste) or Group B (experimental: 5 wt.% chitosan nanoparticle paste). Both groups apply their designated medication topically four times a day using a sterile swab after rinsing and drying the affected area. Treatment is continued until complete healing of the ulcer occurs. Clinical follow-up examinations are performed periodically at days 0, 1, 6, and 10 to measure the clinical ulcer diameter using a Hu-Friedy periodontal probe and to record subjective pain scores via a Visual Analogue Scale (VAS).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Comparator: Triamcinolone Group | Active comparator | Drug: Triamcinolone Acetonide 0.1% Oral PastePatients received triamcinolone acetonide 0.1% oral paste (Adcortyl) applied topically 4 times a day until complete healing. |
| Experimental: Chitosan Nanoparticle Group | Experimental | Drug: 5 wt.% Chitosan Nanoparticle PastePatients received mucoadhesive 5 wt.% chitosan nanoparticle paste applied topically 4 times a day until complete healing. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients complaining of oral recurrent ulcers with signs of minor recurrent aphthous stomatitis.
- History of oral recurrent ulcers with a recurrence rate of 2 to 3 times per year.
- Ulcer diameter less than 1 cm at baseline.
- Maximum of 4 days passed since the emergence of the current ulcer.
- No use of any prior medications or treatment for the current ulcer.
Key exclusion criteria (3 listed)
- Background of systemic diseases, including diabetes mellitus.
- Connective tissue diseases such as Lupus.
- Syndromes or diseases related to aphthous ulcers, such as cyclic neutropenia and Behcet's disease.
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 |
|---|---|---|
| Triamcinolone Acetonide 0.1% Oral PasteAlso: AdcortylStandard reference topical corticosteroid ointment utilized as the active standard of care control. | Drug | Active Comparator: Triamcinolone Group |
| 5 wt.% Chitosan Nanoparticle PasteAlso: Chitosan Paste, CNSynthesized via ionic gelation method using low molecular weight chitosan and sodium tripolyphosphate, formulated into a 5 wt.% mucoadhesive paste. | Drug | Experimental: Chitosan Nanoparticle Group |
Primary outcome
Change in clinical ulcer diameter
Time frame: Days 0, 1, 6, and 10
Measured in millimeters using a Hu-Friedy periodontal probe to evaluate clinical wound contraction and reduction in lesion size.
1 secondary outcome
Change in pain severity score
Time frame: Days 0, 1, 6, and 10
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 14 Jul 2026.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Triamcinolone Acetonide 0.1% Oral Paste and 5 wt.% Chitosan Nanoparticle Paste in people with Recurrent Aphthous Stomatitis and Oral Ulcers, run by Kerman University of Medical Sciences.
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 6 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: finished, as of the sponsor's last update on 14 Jul 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Change in clinical ulcer diameter (time frame: Days 0, 1, 6, and 10). 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 14 Jul 2026.