A Phase 2 interventional study of Triamcinolone Acetonide 0.1% Oral Paste and 5 wt.% Chitosan Nanoparticle Paste in Recurrent Aphthous Stomatitis and Oral Ulcers, sponsored by Kerman University of Medical Sciences. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-14.
Sponsored by Kerman University of Medical Sciences · Phase 2, Interventional, and Treatment
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.
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).
63 studies on the registry are indexed under Stomatitis, Aphthous; 17 are open to participants now.
This study's enrollment of 30 is below the median of 41 across 54 interventional studies indexed under Stomatitis, Aphthous.
Browse Stomatitis, Aphthous studies →Kerman University of Medical Sciences is the lead sponsor of 6 studies on the registry; none are open to participants now.
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Exclusion Criteria:
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients received triamcinolone acetonide 0.1% oral paste (Adcortyl) applied topically 4 times a day until complete healing.
Drug: Triamcinolone Acetonide 0.1% Oral Paste
Patients received mucoadhesive 5 wt.% chitosan nanoparticle paste applied topically 4 times a day until complete healing.
Drug: 5 wt.% Chitosan Nanoparticle Paste
Standard reference topical corticosteroid ointment utilized as the active standard of care control.
Also known as: Adcortyl
Synthesized via ionic gelation method using low molecular weight chitosan and sodium tripolyphosphate, formulated into a 5 wt.% mucoadhesive paste.
Also known as: Chitosan Paste, CN
Change in clinical ulcer diameter
Measured in millimeters using a Hu-Friedy periodontal probe to evaluate clinical wound contraction and reduction in lesion size.
Time frame: Days 0, 1, 6, and 10
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).
Time frame: Days 0, 1, 6, and 10
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Kerman University of Medical Sciences