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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
30
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.
Standard commercial Nystatin oral suspension (100,000 U/mL) manufactured by Jaber Ebne Hayyan Pharmaceutical Company, utilized as the reference active control.
Faculty of Dentistry, Kerman University of Medical Sciences
Kerman, Kerman, Iran
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.
Time frame: Baseline, 1 week, and 2 weeks
Change in burning sensation
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.
Time frame: Baseline, 1 week, and 2 weeks
Microbiological findings from palatal smears
Mean count of fungal structures (mycelia and blastospores) examined via Gram-stained smears under light microscopy.
Time frame: Baseline and 2 weeks
Overall clinical response rate
Percentage of participants achieving complete recovery (total elimination of erythematous lesions) or partial recovery (reduction in erythema area).
Time frame: 2 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.