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Nanochitosan paste takes on denture fungal infections

NCT ID NCT07793331

Disease control Sponsor: Kerman University of Medical Sciences Source: ClinicalTrials.gov ↗

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 28, 2026 · Last updated Aug 28, 2026

Summary

Researchers are testing whether a 5% nanochitosan paste can treat oral candidosis, a fungal infection common under dentures. The trial compares this experimental paste with a standard nystatin ointment in 30 adults who wear full dentures and have type 2 denture stomatitis. Participants receive one of the two treatments, and the study measures changes in the size of red lesions, fungal counts, and burning sensation. The goal is to see if the nanochitosan paste works as well as or better than the current antifungal treatment.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
5% nanochitosan paste (low molecular weight chitosan nanoparticles)
What this could lead to
If it works, this could offer a new topical treatment for oral candidosis in denture wearers, potentially reducing reliance on standard antifungals.
What could go wrong
This is a small Phase 2 trial with 30 participants, so results may not apply broadly. The paste's effectiveness and safety compared to nystatin remain uncertain.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

30 people

The number who actually took part.

Started

Jan 2016

Finished

Dec 2016

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

candidiasis denture stomatitis oral candidiasis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Denture stomatitis Oral candidosis

More trials for these conditions

Other studies related to the condition(s) this trial covers.