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

NCT01217281 | Completed

• 1 other identifier: 143
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Kidney Disease; Periodontitis

Keywords

CKD, Renal, Chronic Kidney Disease, Periodontitis, Perio

Outcome Measures

Primary Outcomes (1)

• eGFR

  Estimated Glomerular Filtration Rate

  6 months

Secondary Outcomes (18)

• CRP

  6 months

• d-8-iso prostaglandin F2a

  6 months

• Level of IgG antibodies in serum against periodontal pathogens

  6 months

• Composition of dental plaque

  6 months

• HbA1C

  6 months

Other Outcomes (1)

• Periodontal Indices (PPD, CAL, BOP, GI)

  6 months

Study Arms (2)

Control

NO INTERVENTION

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)

Test/ Non-surgical Periodontal Therapy

ACTIVE COMPARATOR

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

Interventions

Full Mouth Non-Surgical Periodontal Therapy PROCEDURE

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

Test/ Non-surgical Periodontal Therapy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Athens: lead

Study Sites (1)

University of Athens, Dental School, Department of Periodontology

Athens, 11527, Greece

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Periodontitis

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Phoebus N Madianos, PhD

  University of Athens

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Spyros Kouris, DIpDS, MClinDent, PhD Candidate

Study Record Dates

• First Submitted: October 6, 2010
• First Posted: October 8, 2010
• Study Start: January 30, 2012
• Primary Completion: January 12, 2022
• Study Completion: June 18, 2022
• Last Updated: July 24, 2025

Record last verified: 2025-07

Locations

GR (1)