Oral Ulcers, Recurrent Aphthous Stomatitis
Conditions
Keywords
Chitosan, Nanoparticles, Triamcinolone Acetonide, Aphthous Ulcers, Wound Healing
Brief 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. 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).
Interventions
DRUGTriamcinolone Acetonide 0.1% Oral Paste
Standard reference topical corticosteroid ointment utilized as the active standard of care control.
DRUG5 wt.% Chitosan Nanoparticle Paste
Synthesized via ionic gelation method using low molecular weight chitosan and sodium tripolyphosphate, formulated into a 5 wt.% mucoadhesive paste.
Sponsors
Kerman University of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in clinical ulcer diameter | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in pain severity score | Days 0, 1, 6, and 10 | Subjective pain intensity recorded by patients using a Visual Analogue Scale (VAS) graded from 0 (no pain) to 10 (highest rate of pain). |
Outcome results
None listed