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
- 1
- 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
- •Inclusion and
排除标准
- •Inclusion and Exclusion Criteria List the inclusion/exclusion criteria:
- •There will be three groups in the study:
- •Control groups: There will be 2 control groups. The data from these two groups will help establish the baseline for the different parameters to be evaluated in the experimental population.
- •Group 1: moderate to severe generalized periodontitis (PD) (no kidney disease).
- •Group 2: healthy controls, no PD or kidney disease. Inclusion Criteria
- •Subjects of both sexes, 21 to 75 years of age will be included.
- •Subjects must have moderate to severe generalized periodontitis (PD) (Group 1) (n=50) or no PD (Group 2) (n=50). PD is defined as a patient in the 3rd or later decades of life with the presence of at least 20 natural teeth, >30% of which exhibit: probing depth > 6mm, attachment loss > 3 mm, bleeding on probing, alveolar bone crest > 3 mm from cemento-enamel junction [CEJ]. Healthy controls will also have > 20 teeth, but no alveolar bone loss, attachment loss or BOP and alveolar bone crest 1-2 mm from the CEJ.
- •No kidney disease
- •All potential subjects must sign an informed consent prior to study enrollment.
- •Exclusion Criteria
- •Periodontal treatment (i.e., surgical or nonsurgical) within 3 months prior to enrollment.
- •Treatment with antibiotics within 3 months prior to enrollment.
- •Presence of heart murmur, history of rheumatic fever, valvular disease, prosthetic joint replacement necessitating antibiotic prophylaxis.
- •Kidney disease
- •Cancer or chronic viral infections such as HIV and hepatitis B
- •Inability to take Metronidazole and Amoxicillin combination due to allergy.
- •Experimental group:
- •Group 3: Patients with chronic kidney disease : i. Group 3a- stage 5 (without dialysis, glomerular filtration rate (GFR) < 20)/ stage 5D (on dialysis), awaiting kidney transplant. (n=50) ii. Group 3b- Stages 2-4 (patients who have had either a living donor transplant (n=25), or deceased donor transplant within the last 2 years (n=25), with /without no history of rejection of kidney transplant) (total n=50).
- •Inclusion Criteria
- •Subjects of both sexes, 21 to 75 years of age will be included.
- •All potential subjects must sign an informed consent prior to study enrollment.
- •All potential subjects should be able to drive or be driven to the DCG for dental treatment and follow-up visits.
- •For Group 3b subjects, post-transplant group, glomerular filtration rate with creatinine clearance rate should be in the range of 1.5 - 1.9 ml/min. This will yield a more uniform subject population for statistical analysis of the data.
- •Exclusion Criteria
- •Active, chronic viral infections such as HIV, Hepatitis B, Hepatitis C (these patients are immunocompromised and on antiviral drugs, which might result in an altered immune profile for such patients).
- •Inability to take Metronidazole and Amoxicillin combination due to allergy or poor kidney function.
研究组 & 干预措施
Periodontitis, no kidney disease
Dental intervention i. Full mouth intraoral X-rays (FMX)
ii. Full periodontal exam, diagnosis, Oral hygiene instructions (OHI)
iii. RX: 7 days of p.o. metronidazole (250mg)/amoxicillin (500mg) T.I.D., combined with local chlorhexidine rinses (not for subjects with Kidney transplant).
iv. Single visit intensive scaling and root planning (SRP) (full mouth)
v. Re-evaluation after 4-6 weeks (referral for definitive treatment)
vi. Extraction of teeth deemed hopeless based on periodontal, endodontic or restorative considerations
vii. Caries control, sedative dressing (palliative), referral to endodontic dentist for root canal treatment (RCT)
干预措施: dental intervention (Procedure)
Experimental- chronic kidney disease
Dental intervention i. Full mouth intraoral X-rays (FMX)
ii. Full periodontal exam, diagnosis, Oral hygiene instructions (OHI)
iii. RX: 7 days of p.o. metronidazole (250mg)/amoxicillin (500mg) T.I.D., combined with local chlorhexidine rinses (not for subjects with Kidney transplant).
iv. Single visit intensive scaling and root planning (SRP) (full mouth)
v. Re-evaluation after 4-6 weeks (referral for definitive treatment)
vi. Extraction of teeth deemed hopeless based on periodontal, endodontic or restorative considerations
vii. Caries control, sedative dressing (palliative), referral to endodontic dentist for root canal treatment (RCT)
干预措施: dental intervention (Procedure)
Control- no Periodontitis or kidney disease.
Only regular dental cleaning
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