Denture Stomatitis, Oral Candidosis
Conditions
Keywords
Candida albicans, Chitosan, Nanoparticles, Oral infection, Nystatin
Brief summary
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.
Detailed description
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.
Interventions
DRUG5% Nanochitosan Paste
A 5% paste of low molecular weight chitosan nanoparticles prepared via the ionic gelation method using sodium tripolyphosphate.
DRUGNystatin Ointment
Standard commercial antifungal Nystatin ointment utilized as the active reference treatment.
Sponsors
Kerman University of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
This is a single-blind clinical trial where the drug label was covered in the Nystatin group to ensure participant blinding to the treatment allocation.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in erythematous surface area | Baseline, 1 week, and 2 weeks | The size of the erythematous plaques under the denture-bearing surface is measured in square millimeters (mm2) to evaluate clinical healing. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Microbiological palatal cell culture findings | Baseline and 2 weeks | The average number of fungal structures (mycelium and blastospore) observed in smears prepared from the palatal mucosa to quantify infection severity. |
| Change in burning sensation | Baseline, 1 week, and 2 weeks | 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. |
Outcome results
None listed