Effects of Denture-Related Stomatitis on Blood Pressure in Denture Wearers

Study Overview
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Brief Summary
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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.

Official Title
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Effects of Denture-Related Stomatitis on Blood Pressure, Endothelial Function and Systemic Immune Response in Patients With Dentures

Conditions
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Denture Stomatitis

Intervention / Treatment
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* Drug: Nystatin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with dental prostheses used for at least 6 months, Substantial portion of the oral mucosa covered by dental prosthesis. Exclusion Criteria: acute inflammatory disorders other than denture-related stomatitis, neoplastic disease relapses or chemotherapy courses less than 5 years before the enrolment, antibiotics in less than 4 weeks before the enrolment, anti-inflammatory drugs (steroids and non-steroidal, excluding aspirin in doses less than 80 mg) in less than 2 months before the enrolment, history of myocardial infarction, acute coronary incident or vascular inflammation in 5 weeks or less before the enrolment, chronic haematological disorders and immunodeficiencies less than 5 weeks before the enrolment, major medication changes less than 5 weeks before the enrolment or during study.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Control group<br>Denture wearers without clinical signs of denture-related stomatitis confirmed with negative Candida swabs. | |
| Denture-related stomatitis group<br>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]. | Drug: Nystatin<br>* 100 000 IU every 6 h as a suspension<br>* Other names: Nilstat;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Denture stomatitis, Dentures, Denture wearers