NCT01609725已完成不适用
Impact of Periodontal Therapy in Flow-mediated Dilation and Serum Levels of Cardiovascular Risk Biomarkers in Coronary Artery Disease Patients: 12 Months Randomized Controlled Trial
Federal University of Rio Grande do Sul2 个研究点 分布在 1 个国家目标入组 93 人开始时间: 2012年1月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 93
- 试验地点
- 2
- 主要终点
- Changes in C reactive protein
研究概览
简要总结
Gingival inflammation has been associated with cardiovascular diseases, including heart attack and stroke, because of elevation of blood risk markers such as cholesterol, glucose and C reactive protein. The treatment of gingival diseases decreases the concentration of these risk factors in the blood of cardiovascular patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •35 years and older
- •coronary artery disease
- •more than 10 teeth
- •chronic periodontitis defined as 2 non-adjacent teeth with probing depth 5+mm and periodontal attachment loss 4+mm
排除标准
- •use of antibiotics in the last 6 months
- •periodontal therapy in the last 12 months
研究组 & 干预措施
Comprehensive treatment
Experimental
Test treatment group
干预措施: Subgingival scaling and root planing (Device)
Community treatment
Other
Control treatment group
干预措施: Oral prophylaxis (Device)
结局指标
主要结局
Changes in C reactive protein
时间窗: Baseline, 3, 6 and 12 months
Changes in flow-mediated dilation
时间窗: Baseline, 1, 3 and 6 months
次要结局
- Changes in Interleukin 1B concentrations(Baseline, 3, 6, 12 months)
- Changes in Interleukin 6(Baseline, 3, 6, 12 months)
- Changes in TNF alpha(Baseline, 3, 6, 12 months)
- Changes in Interleukin 8(Baseline, 3, 6, 12 months)
- Changes in Cholesterol(Baseline, 3, 6, 12 months)
- Changes in Glycated hemoglobin(Baseline, 3, 6, 12 months)
- Changes in LDL/HDL(Baseline, 3, 6, 12 months)
- Changes in Fibrinogen(Baseline, 3, 6, 12 months)
研究者
Alex Nogueira Haas
Professor
Federal University of Rio Grande do Sul
研究点 (2)
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