CompletedPhase 2

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

Iran30 participantsStarted 2016-01-17

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in erythematous palatal mucosa lesion area

Timeframe: Baseline, 1 week, and 2 weeks

Trial details

NCT IDNCT07694024

SponsorKerman University of Medical Sciences

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2016-05-04

View on ClinicalTrials.gov More Denture Stomatitis trials