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

NCT07694024 | Completed Phase 2

• 1 other identifier: IR.KMU.REC.1394.723
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Denture Stomatitis; Chronic Atrophic Candidiasis

Keywords

Chitosan; Nanoparticles; Nystatin; Oral Candidiasis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change in burning sensation

  Baseline, 1 week, and 2 weeks

• Microbiological findings from palatal smears

  Baseline and 2 weeks

• Overall clinical response rate

  2 weeks

Study Arms (2)

Experimental: Nanochitosan Group

EXPERIMENTAL

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

Active Comparator: Nystatin Group

ACTIVE COMPARATOR

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

Interventions

1% Nanochitosan Solution DRUG

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.

Also known as: Chitosan Nanoparticles

Experimental: Nanochitosan Group

Nystatin Oral Suspension DRUG

Standard commercial Nystatin oral suspension (100,000 U/mL) manufactured by Jaber Ebne Hayyan Pharmaceutical Company, utilized as the reference active control.

Also known as: Nistat

Active Comparator: Nystatin Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Kerman University of Medical Sciences: lead

Study Sites (1)

Faculty of Dentistry, Kerman University of Medical Sciences

Kerman, Kerman, 7618868345, Iran

Location

MeSH Terms

Conditions

Stomatitis, Denture; Candidiasis, Oral

Condition Hierarchy (Ancestors)

Stomatitis; Mouth Diseases; Stomatognathic Diseases; Candidiasis; Mycoses; Bacterial Infections and Mycoses; Infections

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Commercial labels were removed from the medication bottles before delivery to maintain participant blinding.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Oral Medicine

Model Details: A randomized, parallel-group clinical trial to compare the efficacy of 1% nanochitosan solution with Nystatin oral suspension.

Study Record Dates

• First Submitted: July 3, 2026
• First Posted: July 9, 2026
• Study Start: January 17, 2016
• Primary Completion: May 4, 2016
• Study Completion: May 4, 2016
• Last Updated: July 13, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)