The Effect of Non-surgical Periodontal Treatment in the Renal Function of Patients With Chronic Kidney Disease: RCT

University of Athens60 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Chronic Kidney Disease Periodontitis

Interventions

Full Mouth Non-Surgical Periodontal TherapyPROCEDURE

Non-surgical Periodontal Therapy provided in two sessions, one for the right half and one for the left half of the dentition. Treatment sessions are provided within one week. No antibiotics or other adjunctive medications are to be used

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (1)

University of Athens, Dental School, Department of Periodontology

Athens, Greece

Outcomes

Primary Outcomes

eGFR

Estimated Glomerular Filtration Rate

Time frame: 6 months

Secondary Outcomes

CRP

C-Reactive Protein level

Time frame: 6 months

d-8-iso prostaglandin F2a

Time frame: 6 months

Level of IgG antibodies in serum against periodontal pathogens

Serum samples will be screened for the presence of IgG antibodies against the below mentioned periodontal pathogens, using the "checkerboard immunoblotting" method: Porphyromonas gingivalis, Prevotella intermedia, Prevotella nigrescens, Bacteroides forsythus, Treponema denticola, Fusobacterium nucleatum, Actinobacillus actinomycetemcomitans, Campylobacter rectus, Eikenella corrodens, Peptostreptococcus micros, Veillonella parvula, Capnocytophaga ochracea, Streptococcus intermedius, Streptococcus sanguis και Streptococcus oralis.per

Time frame: 6 months

Composition of dental plaque

Samples of subgingival plaque will be assessed using DNA probes according to the "checkerboard DNA- DNA hybridization" method. DNA probes will be used against the following bacteria: Porphyromonas gingivalis, Prevotella intermedia, Prevotella nigrescens, Bacteroides forsythus, Treponema denticola, Fusobacterium nucleatum, Actinobacillus actinomycetemcomitans, Campylobacter rectus, Eikenella corrodens, Peptostreptococcus micros, Veillonella parvula, Capnocytophaga ochracea, Streptococcus intermedius, Streptococcus sanguis and Streptococcus oralis

Time frame: 6 months

HbA1C

Glycosylated Hemoglobin

Time frame: 6 months

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.