Status:
TERMINATED
Dental Intervention Plan for Chronic Kidney Disease Patients Awaiting or With Kidney Transplant
Lead Sponsor:
Augusta University
Conditions:
Chronic Kidney Disease
Chronic Periodontitis, Generalized, Moderate
Eligibility:
All Genders
21-75 years
Phase:
NA
Brief Summary
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 provi...
Detailed Description
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 a...
Eligibility Criteria
Inclusion
- Inclusion and Exclusion Criteria
- 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.
- 1\) Group 1: moderate to severe generalized periodontitis (PD) (no kidney disease).
- 2\) 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:
- 3\) 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.
Exclusion
Key Trial Info
Start Date :
November 9 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 4 2022
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT04020458
Start Date
November 9 2018
End Date
January 4 2022
Last Update
July 21 2023
Active Locations (1)
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1
Augusta University-Dental College of Georgia
Augusta, Georgia, United States, 30912