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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental: Nanochitosan Group | Experimental | Participants in this group received a 1% nanochitosan solution prepared via the ionic gelation technique. They rinsed with 2 mL of the solution four times a day for 2 minutes over a 2-week period. Patients were instructed to remove their dentures prior to each rinse. |
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| Active Comparator: Nystatin Group | Active Comparator | Participants in this group received a standard Nystatin oral suspension (100,000 U/mL). They rinsed with 2 mL of the suspension four times a day for 2 minutes over a 2-week period. Patients were instructed to remove their dentures prior to each rinse. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 1% Nanochitosan Solution | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, 1 week, and 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in burning sensation | Assessed using a Visual Analog Scale (VAS) to measure the level of discomfort and irritation. | Baseline, 1 week, and 2 weeks |
| Microbiological findings from palatal smears |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Dentistry, Kerman University of Medical Sciences | Kerman | Kerman | 7618868345 | Iran |
To protect participant privacy and maintain clinical data confidentiality, individual participant data (IPD) will not be shared publicly. However, the study protocol and de-identified data may be made available to researchers upon reasonable request to the corresponding author.
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| ID | Term |
|---|---|
| D013282 | Stomatitis, Denture |
| D002180 | Candidiasis, Oral |
| ID | Term |
|---|---|
| D013280 | Stomatitis |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D002177 | Candidiasis |
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A randomized, parallel-group clinical trial to compare the efficacy of 1% nanochitosan solution with Nystatin oral suspension.
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Commercial labels were removed from the medication bottles before delivery to maintain participant blinding.
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| Nystatin Oral Suspension | Drug | Standard commercial Nystatin oral suspension (100,000 U/mL) manufactured by Jaber Ebne Hayyan Pharmaceutical Company, utilized as the reference active control. |
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Mean count of fungal structures (mycelia and blastospores) examined via Gram-stained smears under light microscopy.
| 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). | 2 weeks |
| D009181 |
| Mycoses |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |