A Phase 2 interventional study of 5% Nanochitosan Paste and Nystatin Ointment in Denture Stomatitis and Oral Candidosis, sponsored by Kerman University of Medical Sciences. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-10.
Sponsored by Kerman University of Medical Sciences · Phase 2, Interventional, and Treatment
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.
21 studies on the registry are indexed under Stomatitis, Denture; 1 is open to participants now.
This study's enrollment of 30 is close to the median of 30 across 17 interventional studies indexed under Stomatitis, Denture.
Browse Stomatitis, Denture studies →Kerman University of Medical Sciences is the lead sponsor of 6 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients received 5% nanochitosan paste applied on the palatal areas four times a day for two weeks.
Drug: 5% Nanochitosan Paste
Patients received Nystatin ointment applied on the palatal areas four times a day for two weeks.
Drug: Nystatin Ointment
A 5% paste of low molecular weight chitosan nanoparticles prepared via the ionic gelation method using sodium tripolyphosphate.
Also known as: Low molecular weight nanochitosan paste
Standard commercial antifungal Nystatin ointment utilized as the active reference treatment.
Also known as: Nistat (100,000 U/ml)
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
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
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Kerman University of Medical Sciences