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

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.

Study Overview

• Status: Completed
• Conditions: Recurrent Aphthous Stomatitis; Oral Ulcers
• Intervention / Treatment: Drug: Triamcinolone Acetonide 0.1% Oral Paste; Drug: 5 wt.% Chitosan Nanoparticle Paste

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 Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Active Comparator: Triamcinolone Group; 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; Standard reference topical corticosteroid ointment utilized as the active standard of care control.; Other Names: Adcortyl
Experimental: Experimental: Chitosan Nanoparticle Group; Patients received mucoadhesive 5 wt.% chitosan nanoparticle paste applied topically 4 times a day until complete healing.	Drug: 5 wt.% Chitosan Nanoparticle Paste; Synthesized via ionic gelation method using low molecular weight chitosan and sodium tripolyphosphate, formulated into a 5 wt.% mucoadhesive paste.; Other Names: CN; Chitosan Paste

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Kerman University of Medical Sciences

Study record dates

Study Major Dates

• Study Start (Actual): April 21, 2009
• Primary Completion (Actual): November 3, 2009
• Study Completion (Actual): December 1, 2009

Study Registration Dates

• First Submitted: July 9, 2026
• First Submitted That Met QC Criteria: July 9, 2026
• First Posted (Actual): July 14, 2026

Study Record Updates

• Last Update Posted (Actual): July 14, 2026
• Last Update Submitted That Met QC Criteria: July 9, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Wound Healing; Chitosan; Triamcinolone Acetonide; Aphthous Ulcers; Nanoparticles
• Additional Relevant MeSH Terms: Mouth Diseases; Stomatognathic Diseases; Stomatitis; Oral Ulcer; Stomatitis, Aphthous; Pharmaceutical Preparations; Dosage Forms; Polycyclic Compounds; Triamcinolone; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Steroids, Fluorinated; Triamcinolone Acetonide; Ointments; Gramicidin, Neomycin Sulfate, Nystatin, Triamcinolone Acetonide Drug Combination
• Other Study ID Numbers: IR.KMU.REC.1388.111

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No