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NCT Number: NCT07793331

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

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.

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Key information

Conditions

Denture Stomatitis Bacterial Infections and Mycoses Candidiasis Infections Mouth Diseases Mycoses Oral Candidosis Stomatitis Stomatitis, Denture Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

About this study

Denture stomatitis, also called chronic atrophic candidosis, is a common chronic disease in people who use full dentures, primarily caused by Candida albicans. This randomized single-blind clinical trial evaluates the antifungal effect of nanochitosan particles prepared by the ionic gelation method in a 5% paste formulation. Thirty patients using full dentures and suffering from type 2 denture stomatitis are randomly divided into two groups of fifteen. One group receives the 5% nanochitosan paste and the other receives Nystatin ointment. Both groups apply their respective medications to the palatal areas four times a day for two weeks. Patients are instructed to remove their dentures during application. Clinical and microbiological assessments are performed before treatment and after two weeks to evaluate changes in erythematous plaque surface area, palatal cell culture colony counts, and burning sensation.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

5% Nanochitosan Paste

Drug

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

Other names: Low molecular weight nanochitosan paste

Nystatin Ointment

Drug

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

Other names: Nistat (100,000 U/ml)

Primary outcomes

  1. Change in erythematous surface area

    Time frame: Baseline, 1 week, and 2 weeks

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

Secondary outcomes

  1. Microbiological palatal cell culture findings

    Time frame: Baseline and 2 weeks

    The average number of fungal structures (mycelium and blastospore) observed in smears prepared from the palatal mucosa to quantify infection severity.

  2. Change in burning sensation

    Time frame: Baseline, 1 week, and 2 weeks

    Subjective burning sensation was assessed using a Visual Analog Scale (VAS). The scale is graded from a minimum value of 0 (no discomfort) to a maximum value of 10 (the highest rate of pain and irritation). Higher scores indicate a worse clinical outcome.

Sponsors and collaborators

Lead sponsor

Kerman University of Medical Sciences

Other

Registry information

Official study title

Antifungal Effect of Chitosan Nanoparticles Paste Against Oral Candidosis

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Aug 28, 2026
Registry last updated
Aug 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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