Effects of Denture-Related Stomatitis on Blood Pressure, Endothelial Function and Systemic Immune Response in Patients With Dentures
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Change from baseline in blood pressure
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with dental prostheses used for at least 6 months,
- •Substantial portion of the oral mucosa covered by dental prosthesis.
排除标准
- •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.
研究组 & 干预措施
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].
干预措施: Nystatin (Drug)
结局指标
主要结局
Change from baseline in blood pressure
时间窗: Within 48h Prior to denture-related stomatitis treatment; 48h after recovery from denture-related stomatitis; 2 months after recovery from denture-related stomatitis
Ambulatory Blood Pressure Monitoring System
次要结局
- Change from baseline in endothelial function(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(Within 48h Prior to denture-related stomatitis treatment; 48h after recovery from denture-related stomatitis; 2 months after recovery from denture-related stomatitis)
研究者
Tomasz Guzik
MD, PhD
Jagiellonian University