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

Not Applicable

Completed

• Conditions: Periodontitis; Chronic Kidney Disease

• Registration Number: NCT01217281
• Lead Sponsor: University of Athens

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-10-06
• Study First Submitted QC: 2010-10-07
• Study First Posted: 2010-10-08
• Study Start: 2012-01-30
• Primary Completion: 2022-01-12
• Study Completion: 2022-06-18
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-20
• Last Update Posted: 2025-07-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
eGFR	6 months	Estimated Glomerular Filtration Rate

Secondary Outcome Measures

Name	Time	Method
CRP	6 months	C-Reactive Protein level
d-8-iso prostaglandin F2a	6 months	d-8-iso prostaglandin F2a
Triglycerides	6 months	Serum triglycerides
LDL / HDL	6 months	Low / High Density Lipoprotein
Serum Urea	6 months	Serum Urea
Serum Albumin	6 months	Serum Albumin
Urine Albumin	6 months	Urine Albumin
Urine Creatinine	6 months	Urine Creatinine
Cr/Alb ratio	6 months	Urine Creatinine / Albumin Ration
Level of IgG antibodies in serum against periodontal pathogens	6 months	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
Composition of dental plaque	6 months	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
HbA1C	6 months	Glycosylated Hemoglobin
FMD / NMD	6 months	Flow Mediated Dialation, Nitroglycerin Mediated Dialation, Assessment of Endothelial Dysfunction
PWV	6 months	Pass Wave Velocity, Assessment of Endothelial Dysfunction
Cholesterol levels	6 months	Chloesterol Levels
AIx	6 months	Augmentaion Index
Ca	6 months	Serum Calcium
P	6 months	Serum Phosphate

Trial Locations

Locations (1)

University of Athens, Dental School, Department of Periodontology; 🇬🇷 Athens, Greece