Dental Intervention Plan for Chronic Kidney Disease Patients Awaiting or With Kidney Transplant
Stopped early · Not applicable
Conditions studied: Chronic Kidney Disease, Chronic Periodontitis, Generalized, Moderate
In brief
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.
Key facts
- Study ID
- NCT04020458
- Run by
- Augusta University
- People needed
- 11
- Starts
- 2018-11-09
- Expected to finish
- 2022-01-04
- Last updated by the study team
- 2023-07-21
Who can join
Age: 21 and older, up to 75. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Augusta University-Dental College of Georgia — Augusta, Georgia, United States
Full record on ClinicalTrials.gov
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