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COMPLETED
NCT07694024
PHASE2

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

Sponsor: Kerman University of Medical Sciences

View on ClinicalTrials.gov

Summary

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.

Official 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2016-01-17

Completion Date

2016-05-04

Last Updated

2026-07-13

Healthy Volunteers

No

Interventions

DRUG

1% Nanochitosan Solution

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.

DRUG

Nystatin Oral Suspension

Standard commercial Nystatin oral suspension (100,000 U/mL) manufactured by Jaber Ebne Hayyan Pharmaceutical Company, utilized as the reference active control.

Locations (1)

Faculty of Dentistry, Kerman University of Medical Sciences

Kerman, Kerman, Iran