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

Kerman University of Medical Sciences30 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Denture Stomatitis Oral Candidosis

Interventions

5% Nanochitosan PasteDRUG

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

Nystatin OintmentDRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Time frame: Baseline, 1 week, and 2 weeks

Secondary Outcomes

Microbiological palatal cell culture findings

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

Time frame: Baseline and 2 weeks

Change in burning sensation

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.

Time frame: Baseline, 1 week, and 2 weeks

Data from ClinicalTrials.gov

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