Efficacy of 5% Nanochitosan Paste in the Treatment of Oral Candidosis

NCT07793331 | Completed Phase 2

• 1 other identifier: IR.Kmu.REC.1394.722
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study is designed to survey the therapeutic effect of a low molecular weight 5% nanochitosan paste against oral candidosis (denture stomatitis) and compare its efficacy with a standard Nystatin ointment.

Conditions

Denture Stomatitis; Oral Candidosis

Keywords

Candida albicans; Chitosan; Nanoparticles; Oral infection; Nystatin

Outcome Measures

Primary Outcomes (1)

• Change in erythematous surface area

  The size of the erythematous plaques under the denture-bearing surface is measured in square millimeters (mm2) to evaluate clinical healing.

  Baseline, 1 week, and 2 weeks

Secondary Outcomes (2)

• Microbiological palatal cell culture findings

  Baseline and 2 weeks

• Change in burning sensation

  Baseline, 1 week, and 2 weeks

Study Arms (2)

Experimental: Nanochitosan Paste Group

EXPERIMENTAL

Patients received 5% nanochitosan paste applied on the palatal areas four times a day for two weeks.

Drug: 5% Nanochitosan Paste

Active Comparator: Nystatin Ointment Group

ACTIVE COMPARATOR

Patients received Nystatin ointment applied on the palatal areas four times a day for two weeks.

Drug: Nystatin Ointment

Interventions

5% Nanochitosan Paste DRUG

A 5% paste of low molecular weight chitosan nanoparticles prepared via the ionic gelation method using sodium tripolyphosphate.

Also known as: Low molecular weight nanochitosan paste

Experimental: Nanochitosan Paste Group

Nystatin Ointment DRUG

Standard commercial antifungal Nystatin ointment utilized as the active reference treatment.

Also known as: Nistat (100,000 U/ml)

Active Comparator: Nystatin Ointment Group

Eligibility Criteria

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

You may qualify if:

• Patients using full dentures.
• Suffering from type 2 denture stomatitis.
• Diagnosis and infection confirmed by an oral medicine specialist.
• Signed written informed consent.

You may not qualify if:

• History of using antifungal drugs, antibiotics, corticosteroids, and saliva-reducing drugs in the previous month.
• Patients with Alzheimer's disease.
• Patients with diabetes mellitus.
• Patients with masticatory muscle disorders.
• Patients with an immune suppressive situation.
• Patients with psychological diseases.

Sponsors & Collaborators

• Kerman University of Medical Sciences: lead

MeSH Terms

Conditions

Stomatitis, Denture; Candidiasis

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: This is a single-blind clinical trial where the drug label was covered in the Nystatin group to ensure participant blinding to the treatment allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DDS, MSD, Oral Medicine Department

Study Record Dates

• First Submitted: August 25, 2026
• First Posted: August 28, 2026
• Study Start: January 1, 2016
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: August 28, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share