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NCT Number: NCT07694024

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Faculty of Dentistry, Kerman University of Medical Sciences

Kerman, 7618868345, Iran

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

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.

Other names: Chitosan Nanoparticles

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.

Other names: Nistat

Primary outcomes

  1. Change in erythematous palatal mucosa lesion area

    Time frame: Baseline, 1 week, and 2 weeks

    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.

Secondary outcomes

  1. Change in burning sensation

    Time frame: Baseline, 1 week, and 2 weeks

    Subjective burning sensation was assessed using a Visual Analogue 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.

  2. Microbiological findings from palatal smears

    Time frame: Baseline and 2 weeks

    Mean count of fungal structures (mycelia and blastospores) examined via Gram-stained smears under light microscopy.

  3. Overall clinical response rate

    Time frame: 2 weeks

    Percentage of participants achieving complete recovery (total elimination of erythematous lesions) or partial recovery (reduction in erythema area).

Sponsors and collaborators

Lead sponsor

Kerman University of Medical Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Jul 9, 2026
Registry last updated
Jul 13, 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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