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Clinical Trials/NCT01217281
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.

Registry
clinicaltrials.gov
Start Date
January 30, 2012
End Date
June 18, 2022
Last Updated
9 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
University of Athens
Responsible Party
Principal Investigator
Principal Investigator

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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