NCT01217281
Completed
Not Applicable
The Effect of Non-surgical Periodontal Treatment in the Renal Function of Patients With Chronic Kidney Disease: A Randomized Clinical Trial
University of Athens1 site in 1 country60 target enrollmentJanuary 30, 2012
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Chronic Kidney Disease
- Sponsor
- University of Athens
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- eGFR
- Status
- Completed
- Last Updated
- 9 months ago
Overview
Brief Summary
Periodontal disease is a bacterially-induced inflammation. As such, it can become a point of entry of bacteria, toxins and cytokines into the systemic blood circulation, thus adversely affecting the function of kidneys. This is turn can aggravate the condition of patients with CKD.
The study hypothesis is that periodontal therapy can improve renal function in patients with CKD and lower the blood levels of markers for systemic inflammation.
Investigators
Spyros Kouris
Spyros Kouris, DIpDS, MClinDent, PhD Candidate
University of Athens
Eligibility Criteria
Inclusion Criteria
- •Chronic Kidney Disease (Stage II, III, IV)
- •At least 12 teeth present in the oral cavity
- •Moderate to severe chronic periodontitis, which is defined as: at least 8 surfaces with periodontal pocket depth (PPD) ≥5mm and at least 4 surfaces with Clinical Attachment Loss (CAL) ≥4mm, distributed in at least two quadrants.
Exclusion Criteria
- •Patients that have had a renal transplant or undergoing dialysis
- •Acute infections or use of antibiotics in the past 3 months.
- •Auto-immune diseases, conditions that cause immunosuppression or use of immunosuppressant medication.
- •Systemic conditions that require antibiotic prophylaxis for routine periodontal therapy.
- •Non-surgical periodontal therapy in the past 6 months or surgical periodontal therapy in the past 12 months.
- •Use of medication that can cause gingival hyperplasia such as cyclosporine or fenintoin.
- •Myocardial infarction or cerebral vascular incident in the past 12 months or uncontrolled angina.
Outcomes
Primary Outcomes
eGFR
Time Frame: 6 months
Estimated Glomerular Filtration Rate
Secondary Outcomes
- CRP(6 months)
- d-8-iso prostaglandin F2a(6 months)
- Triglycerides(6 months)
- LDL / HDL(6 months)
- Serum Urea(6 months)
- Serum Albumin(6 months)
- Urine Albumin(6 months)
- Urine Creatinine(6 months)
- Cr/Alb ratio(6 months)
- Composition of dental plaque(6 months)
- HbA1C(6 months)
- Level of IgG antibodies in serum against periodontal pathogens(6 months)
- FMD / NMD(6 months)
- PWV(6 months)
- AIx(6 months)
- Cholesterol levels(6 months)
- Ca(6 months)
- P(6 months)
Study Sites (1)
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