NCT01217281已完成不适用
The Effect of Non-surgical Periodontal Treatment in the Renal Function of Patients With Chronic Kidney Disease: A Randomized Clinical Trial
University of Athens2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2012年1月30日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- eGFR
研究概览
简要总结
Periodontal disease is a bacterially-induced inflammation. As such, it can become a point of entry of bacteria, toxins and cytokines into the systemic blood circulation, thus adversely affecting the function of kidneys. This is turn can aggravate the condition of patients with CKD.
The study hypothesis is that periodontal therapy can improve renal function in patients with CKD and lower the blood levels of markers for systemic inflammation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic Kidney Disease (Stage II, III, IV)
- •At least 12 teeth present in the oral cavity
- •Moderate to severe chronic periodontitis, which is defined as: at least 8 surfaces with periodontal pocket depth (PPD) ≥5mm and at least 4 surfaces with Clinical Attachment Loss (CAL) ≥4mm, distributed in at least two quadrants.
排除标准
- •Patients that have had a renal transplant or undergoing dialysis
- •Acute infections or use of antibiotics in the past 3 months.
- •Auto-immune diseases, conditions that cause immunosuppression or use of immunosuppressant medication.
- •Systemic conditions that require antibiotic prophylaxis for routine periodontal therapy.
- •Non-surgical periodontal therapy in the past 6 months or surgical periodontal therapy in the past 12 months.
- •Use of medication that can cause gingival hyperplasia such as cyclosporine or fenintoin.
- •Myocardial infarction or cerebral vascular incident in the past 12 months or uncontrolled angina.
结局指标
主要结局
eGFR
时间窗: 6 months
Estimated Glomerular Filtration Rate
次要结局
- CRP(6 months)
- d-8-iso prostaglandin F2a(6 months)
- Triglycerides(6 months)
- LDL / HDL(6 months)
- Serum Urea(6 months)
- Serum Albumin(6 months)
- Urine Albumin(6 months)
- Urine Creatinine(6 months)
- Cr/Alb ratio(6 months)
- Composition of dental plaque(6 months)
- HbA1C(6 months)
- Level of IgG antibodies in serum against periodontal pathogens(6 months)
- FMD / NMD(6 months)
- PWV(6 months)
- AIx(6 months)
- Cholesterol levels(6 months)
- Ca(6 months)
- P(6 months)
研究者
Spyros Kouris
Spyros Kouris, DIpDS, MClinDent, PhD Candidate
University of Athens
研究点 (2)
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