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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Comparator: Triamcinolone Group | Active Comparator | Patients received triamcinolone acetonide 0.1% oral paste (Adcortyl) applied topically 4 times a day until complete healing. |
|
| Experimental: Chitosan Nanoparticle Group | Experimental | Patients received mucoadhesive 5 wt.% chitosan nanoparticle paste applied topically 4 times a day until complete healing. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Triamcinolone Acetonide 0.1% Oral Paste | Drug | Standard reference topical corticosteroid ointment utilized as the active standard of care control. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in clinical ulcer diameter | Measured in millimeters using a Hu-Friedy periodontal probe to evaluate clinical wound contraction and reduction in lesion size. | Days 0, 1, 6, and 10 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Days 0, 1, 6, and 10 |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D013281 | Stomatitis, Aphthous |
| D019226 | Oral Ulcer |
| ID | Term |
|---|---|
| D013280 | Stomatitis |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| D014222 | Triamcinolone Acetonide |
| D009824 | Ointments |
| C014118 | Gramicidin, Neomycin Sulfate, Nystatin, Triamcinolone Acetonide Drug Combination |
| ID | Term |
|---|---|
| D014221 | Triamcinolone |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
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To ensure rigorous single-blinding, medications were dispensed in masked, identical containers by an independent coordinator. The clinical investigator performing all follow-up measurements and scoring was completely blinded to the treatment assignments.
|
| 5 wt.% Chitosan Nanoparticle Paste | Drug | Synthesized via ionic gelation method using low molecular weight chitosan and sodium tripolyphosphate, formulated into a 5 wt.% mucoadhesive paste. |
|
|
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |