Clinical trial NCT01217281: The Effect of Non-surgical Periodontal Treatment in the Renal Function of Patients With Chronic Kidney Disease: RCT
Official title: The Effect of Non-surgical Periodontal Treatment in the Renal Function of Patients With Chronic Kidney Disease: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Kidney Disease
Periodontitis
Keywords: CKD, Renal, Chronic Kidney Disease, Periodontitis, Perio
Lead sponsor: University of Athens
Sponsor class: OTHER
First posted: 2010-10-08
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* Chronic Kidney Disease (Stage I, 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.

Primary outcomes:
measure: eGFR
timeFrame: 6 months
Secondary outcomes:
measure: CRP
timeFrame: 6 months
measure: d-8-iso prostaglandin F2a
timeFrame: 6 months
measure: Level of IgG antibodies in serum against periodontal pathogens
timeFrame: 6 months
measure: Composition of dental plaque
timeFrame: 6 months
measure: HbA1C
timeFrame: 6 months
measure: FMD / NMD
timeFrame: 6 months
measure: PWV
timeFrame: 6 months
measure: AIx
timeFrame: 6 months
measure: Cholesterol levels
timeFrame: 6 months
measure: Ca
timeFrame: 6 months
measure: P
timeFrame: 6 months
measure: Triglycerides
timeFrame: 6 months
measure: LDL / HDL
timeFrame: 6 months
measure: Serum Urea
timeFrame: 6 months
measure: Serum Albumin
timeFrame: 6 months
measure: Urine Albumin
timeFrame: 6 months
measure: Urine Creatinine
timeFrame: 6 months
measure: Cr/Alb ratio
timeFrame: 6 months
Other outcomes:
measure: Periodontal Indices (PPD, CAL, BOP, GI)
timeFrame: 6 months
Locations:
city: Athens
country: Greece
facility: University of Athens, Dental School, Department of Periodontology
Study officials:
affiliation: University of Athens
name: Phoebus N Madianos, PhD
role: PRINCIPAL_INVESTIGATOR
References: