Pilot and Feasibility Clinical Research Grants in Kidney or Urologic Diseases (R21)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 66
- 试验地点
- 2
- 主要终点
- Serum CRP
研究概览
简要总结
The goal of this project is to assess repeated and ongoing oral care and the way it may affect inflammation and quality of life in hemodialysis patients. Two treatment groups will be compared:
-
- ongoing and repeated gum disease therapy including deep tooth cleaning followed by multiple appointments of maintenance
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- single session of gum disease therapy with only one session of deep tooth cleaning Samples of blood will be obtained for study to examine the changes of inflammatory substances in the blood as a result of the two different gum disease treatments. Also, a 14-question survey will be discussed with you to assess oral health related quality of life (OHIP-14) and the way it is affected by oral care.
For this project, four dialysis centers will be randomly assigned to either of the treatment groups #1 or #2 prior to your enrollment. For this purpose, there are two distinct consent forms explaining the visits, procedures and risks of the two treatment groups #1 or #2. As a result, all participants in the same dialysis center will belong to the same treatment group (either #1 or #2) and presented with the corresponding consent form.
This dialysis center has been randomized to treatment group # 1; therefore you will receive ongoing and repeated gum disease therapy including deep tooth cleaning followed by multiple appointments of maintenance.
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient must be referred by nephrologist
- •Patient must be diagnosed with ESRD and on Hemodialysis
- •life expectancy more than one year
- •at least 21 years of age
- •12 or more teeth
- •must meet the Periodontal diagnosis criteria (The diagnosis of periodontitis is based on the definition of moderate periodontitis with at least 2 sites with CAL≥4mm or at least 2 sites with PD≥5mm not on the same tooth (Page and Eke 2007).)
排除标准
- •Anticipating a kidney transplant
- •Active malignancy
- •Poor adherence to hemodialysis
- •Currently prescribed anti-inflammatory medication
- •Temporary catheter for dialysis access
- •Gum disease treatment within the last year
结局指标
主要结局
Serum CRP
时间窗: 6 months
Inflammatory markers
次要结局
- Serum IL-6(6 months)
- Probing depth PD(6 months)
- Clinical attachment levels CAL(6 months)
- OHIP-14(6 months)
- F2 isoprostanes(6 months)
- isofurans(6 months)