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The aim of this study is to evaluate the influence of presence of oral fungal infection, which leads to denture-related stomatitis, on blood pressure, endothelial function and immune cell phenotype in patients wearing dentures.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | Denture wearers without clinical signs of denture-related stomatitis confirmed with negative Candida swabs. | ||
| Denture-related stomatitis group | Denture wearers with clinical signs of denture-related stomatitis, confirmed with positive Candida swabs. Treated for fungal infection, with nystatin [100 000 IU every 6 h for 3 weeks, applied on the infected area of the mucous membrane of the palate and cheeks]. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nystatin | Drug | 100 000 IU every 6 h as a suspension |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in blood pressure | Ambulatory Blood Pressure Monitoring System | Within 48h Prior to denture-related stomatitis treatment; 48h after recovery from denture-related stomatitis; 2 months after recovery from denture-related stomatitis |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in endothelial function | Flow Mediated Dilatation | Within 48h Prior to denture-related stomatitis treatment; 48h after recovery from denture-related stomatitis; 2 months after recovery from denture-related stomatitis |
| Changes in immune cell subset populations from baseline |
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Inclusion Criteria:
Exclusion Criteria:
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Dental clinic patients wearing dentures
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marta Cześnikiewicz-Guzik, PhD | Contact | +48126330003 | marta.czesnikiewicz-guzik@glasgow.ac.uk |
| Name | Affiliation | Role |
|---|---|---|
| Tomasz Guzik, MD, PhD | Jagiellonian University | Principal Investigator |
| Marta Cześnikiewicz-Guzik, PhD | Jagiellonian University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zbigniew Żak Voivodeship Dental Clinic | Recruiting | Krakow | 31-135 | Poland | ||
| Jagiellonian University Dental Clinic |
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| ID | Term |
|---|---|
| D013282 | Stomatitis, Denture |
| ID | Term |
|---|---|
| D013280 | Stomatitis |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| D009761 | Nystatin |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
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Determination of cell subsets, activation markers and intracellular cytokine production |
| Within 48h Prior to denture-related stomatitis treatment; 48h after recovery from denture-related stomatitis; 2 months after recovery from denture-related stomatitis |
| Recruiting |
| Krakow |
| 31-155 |
| Poland |