Dental Intervention Plan for Chronic Kidney Disease Patients Awaiting or With Kidney Transplant
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 11
- 试验地点
- 2
- 主要终点
- Kidney transplant outcome
研究概览
简要总结
The study aims to understand why dental infections in end-stage kidney patients results in poor outcomes for kidney functions and eventually transplant. Further, if an active dental treatment is provided to such patients, does it helps improve the kidney functional parameters, and eventually results in better survival of kidney transplant. In addition, the molecular markers that result in altered interactions between the blood cells and bacteria in these patients will be identified and compared with those found in a healthy subjects, or subjects with gum disease but no kidney disease. Besides, if any of the makers of altered interactions found in the blood can be found to be altered in the saliva samples from the patients with gum disease (periodontitis), and kidney disease, it will help to develop a non-invasive oral risk test for predicting outcomes of kidney transplant survival.
详细描述
PURPOSE: The Dental College of Georgia (DCG) and the Periodontics and Oral Health and Diagnostic Sciences departments propose to develop a collaborative clinical and research program with the Carlos and Marguerite Mason Trust Solid Organ Transplant Center at the Augusta University (AU) Medical Center. The overall goal is to develop a dental intervention program, with a research component, to address the role of dental infections in kidney transplantation outcomes, with the goal of improving best practices for kidney transplant patients. The study, which has been funded by the Mason Trust (C.W. Cutler, PI) is aimed toward improving overall quality of life of the patients on dialysis or with kidney transplant and reducing transplantation complications and failure rates.
AIM 1: To evaluate the effect of dental intervention on kidney transplant outcomes for patients with chronic kidney diseases awaiting kidney transplant/ or having received a kidney transplant within two (2) years. This aim will examine whether dental intervention will improve outcomes of patients with periodontitis (PD) and kidney disease, including kidney function and allograft survival in patients with chronic kidney diseases post-transplantation. Hypothesis is that active dental intervention will result in better oral health in patients with chronic kidney diseases resulting in better transplantation outcomes.
AIM 2: To determine the pathophysiological links between PD and chronic kidney disease with or without kidney transplantation.
Hypothesis is that active treatment of PD in chronic kidney patients will shift the systemic molecular profile towards anti-inflammatory, resulting in better transplant outcomes for these patients. The correlation of expression of various molecular proteins in saliva and blood will help to develop a non-invasive oral risk test for predicting outcomes of kidney transplant survival.
There will be three groups in the study:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Kidney transplant outcome
时间窗: 3 years
% allograft survival
次要结局
未报告次要终点
研究者
Christopher Cutler
Chair and Professor
Augusta University