Efficacy of 1% Nanochitosan Solution in the Treatment of Denture Stomatitis

Evaluation of the Efficacy of 1% Nanochitosan Solution Compared to Nystatin Oral Suspension in the Treatment of Newton's Type II Denture Stomatitis: A Randomized Clinical Trial

The purpose of this study is to evaluate and compare the clinical efficacy of a 1% nanochitosan solution versus a standard Nystatin oral suspension in patients diagnosed with Newton's type II denture stomatitis (chronic atrophic candidiasis). Chitosan nanoparticles are investigated as a potential biocompatible, mucoadhesive alternative to traditional antifungal treatments to accelerate mucosal healing and reduce the erythema of the palatal mucosa.

Study Overview

• Status: Completed
• Conditions: Denture Stomatitis; Chronic Atrophic Candidiasis
• Intervention / Treatment: Drug: 1% Nanochitosan Solution; Drug: Nystatin Oral Suspension

Detailed Description

Denture stomatitis is a common oral mucosal lesion, primarily caused by Candida species under dental prostheses. This randomized single-blind clinical trial investigates the therapeutic properties of a novel 1% nanochitosan formulation synthesized via ionic gelation technique. Eligible participants with Newton's type II denture stomatitis are randomly allocated into two parallel groups. The intervention group receives the 1% nanochitosan solution, and the active control group receives a standard Nystatin oral suspension (100,000 U/mL). Both groups apply 2 mL of their respective medications topically as an oral rinse four times a day for a total duration of 2 weeks. Prior to each application, patients are instructed to remove their dentures to maximize mucosal contact. Clinical outcomes, specifically the change in the erythematous lesion area of the palatal mucosa (measured in square millimeters), are assessed at baseline, at the end of the first week, and at the completion of the second week.

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

Contacts and Locations

Study Locations

• Iran
  • Kerman
    • Kerman, Kerman, Iran, 7618868345
      • Faculty of Dentistry, Kerman University of Medical Sciences

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Complete denture wearers diagnosed with Newton's type II denture stomatitis.
• Diagnosis verified by an oral medicine specialist.
• No use of antifungal agents, antibiotics, corticosteroids, or medications that reduce salivary flow in the month prior to the study.
• Willing to provide written informed consent.

Exclusion Criteria:

• Patients with Alzheimer's disease.
• Patients with diabetes mellitus.
• Patients with masticatory muscle disorders.
• Patients with immunocompromising diseases.
• Patients with psychiatric disorders.

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
Experimental: Experimental: Nanochitosan Group; Participants in this group received a 1% nanochitosan solution prepared via the ionic gelation technique. They rinsed with 2 mL of the solution four times a day for 2 minutes over a 2-week period. Patients were instructed to remove their dentures prior to each rinse.	Drug: 1% Nanochitosan Solution; A novel topical formulation of chitosan nanoparticles synthesized from low-molecular-weight chitosan using the ionic gelation method, prepared as a 1 wt.% aqueous solution.; Other Names: Chitosan Nanoparticles
Active Comparator: Active Comparator: Nystatin Group; Participants in this group received a standard Nystatin oral suspension (100,000 U/mL). They rinsed with 2 mL of the suspension four times a day for 2 minutes over a 2-week period. Patients were instructed to remove their dentures prior to each rinse.	Drug: Nystatin Oral Suspension; Standard commercial Nystatin oral suspension (100,000 U/mL) manufactured by Jaber Ebne Hayyan Pharmaceutical Company, utilized as the reference active control.; Other Names: Nistat

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in erythematous palatal mucosa lesion area	The total surface area of the erythematous lesion on the palatal mucosa is measured and calculated in square millimeters (mm²) to determine the reduction in denture stomatitis inflammation and evaluate clinical efficacy.	Baseline, 1 week, and 2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in burning sensation	Assessed using a Visual Analog Scale (VAS) to measure the level of discomfort and irritation.	Baseline, 1 week, and 2 weeks
Microbiological findings from palatal smears	Mean count of fungal structures (mycelia and blastospores) examined via Gram-stained smears under light microscopy.	Baseline and 2 weeks
Overall clinical response rate	Percentage of participants achieving complete recovery (total elimination of erythematous lesions) or partial recovery (reduction in erythema area).	2 weeks

Collaborators and Investigators

• Sponsor: Kerman University of Medical Sciences

Study record dates

Study Major Dates

• Study Start (Actual): January 17, 2016
• Primary Completion (Actual): May 4, 2016
• Study Completion (Actual): May 4, 2016

Study Registration Dates

• First Submitted: July 3, 2026
• First Submitted That Met QC Criteria: July 3, 2026
• First Posted (Actual): July 9, 2026

Study Record Updates

• Last Update Posted (Actual): July 9, 2026
• Last Update Submitted That Met QC Criteria: July 3, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Chitosan; Nystatin; Nanoparticles; Oral Candidiasis
• Additional Relevant MeSH Terms: Mouth Diseases; Stomatognathic Diseases; Infections; Bacterial Infections and Mycoses; Mycoses; Candidiasis; Stomatitis; Stomatitis, Denture; Candidiasis, Oral
• Other Study ID Numbers: IR.KMU.REC.1394.723

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: To protect participant privacy and maintain clinical data confidentiality, individual participant data (IPD) will not be shared publicly. However, the study protocol and de-identified data may be made available to researchers upon reasonable request to the corresponding author.

Drug and device information, study documents

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