Efficacy of 5% Chitosan Nanoparticle Paste in the Treatment of Recurrent Aphthous Stomatitis

Kerman University of Medical Sciences30 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Recurrent Aphthous Stomatitis Oral Ulcers

Interventions

Triamcinolone Acetonide 0.1% Oral PasteDRUG

Standard reference topical corticosteroid ointment utilized as the active standard of care control.

5 wt.% Chitosan Nanoparticle PasteDRUG

Synthesized via ionic gelation method using low molecular weight chitosan and sodium tripolyphosphate, formulated into a 5 wt.% mucoadhesive paste.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.