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

The Effect of Non-surgical Periodontal Treatment in the Renal Function of Patients With Chronic Kidney Disease: A Randomized Clinical Trial

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 Overview

• Status: Completed
• Conditions: Periodontitis; Chronic Kidney Disease
• Intervention / Treatment: Procedure: Full Mouth Non-Surgical Periodontal Therapy

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Greece
  • Athens, Greece, 11527
    • University of Athens, Dental School, Department of Periodontology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; Full mouth supra-gingival debridement using hand instruments and ultrasonic scalers, in one session. Patient motivation and oral hygiene instructions Review and prophylaxis at 1 month, 3 months and 6 months after initial treatment session. Full mouth periodontal therapy provided at the end of the 6month period (supra and sub- gingival full mouth scaling)
Active Comparator: Test/ Non-surgical Periodontal Therapy; Full mouth periodontal therapy (sub and supra- gingival debridement) provided under local anaesthesia in two half-mouth sessions. Review and prophylaxis 1 month, 3 months and 6 months after the end of the initial therapy.	Procedure: Full Mouth Non-Surgical Periodontal Therapy; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
eGFR	estimated Glomerular Filtration Rate	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CRP		6 months
Cystatin C	Surrogate marker for filtration rate	6 months
d-8-iso prostaglandin F2a		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	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	6 months
Il-6		6 months
TNF-α		6 months

Collaborators and Investigators

• Sponsor: University of Athens
• Investigators: Principal Investigator: Phoebus N Madianos, PhD, University of Athens

Study record dates

Study Major Dates

• Study Start: June 1, 2010
• Primary Completion (Actual): January 12, 2022
• Study Completion (Actual): May 18, 2022

Study Registration Dates

• First Submitted: October 6, 2010
• First Submitted That Met QC Criteria: October 7, 2010
• First Posted (Estimated): October 8, 2010

Study Record Updates

• Last Update Posted (Actual): October 11, 2023
• Last Update Submitted That Met QC Criteria: October 9, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: CKD, Renal, Chronic Kidney Disease, Periodontitis, Perio
• Additional Relevant MeSH Terms: Pathologic Processes; Urologic Diseases; Disease Attributes; Renal Insufficiency; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Chronic Disease; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Renal Insufficiency, Chronic; Periodontitis
• Other Study ID Numbers: 143