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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01217281
First Posted: October 8, 2010
Last Update Posted: October 26, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Spyros Kouris, University of Athens
  Purpose

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.


Condition Intervention
Chronic Kidney Disease Periodontitis Procedure: Full Mouth Non-Surgical Periodontal Therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Non-surgical Periodontal Treatment in the Renal Function of Patients With Chronic Kidney Disease: A Randomized Clinical Trial

Resource links provided by NLM:


Further study details as provided by Spyros Kouris, University of Athens:

Primary Outcome Measures:
  • eGFR [ Time Frame: 6 months ]
    estimated Glomerular Filtration Rate


Secondary Outcome Measures:
  • Cystatin C [ Time Frame: 6 months ]
    Surrogate marker for filtration rate

  • CRP [ Time Frame: 6 months ]
  • d-8-iso prostaglandin F2a [ Time Frame: 6 months ]
  • Level of IgG antibodies in serum against periodontal pathogens [ Time Frame: 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 [ Time Frame: 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

  • Il-6 [ Time Frame: 6 months ]
  • TNF-α [ Time Frame: 6 months ]

Enrollment: 48
Study Start Date: June 2010
Estimated Study Completion Date: January 2019
Estimated Primary Completion Date: July 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01217281


Locations
Greece
University of Athens, Dental School, Department of Periodontology
Athens, Greece, 11527
Sponsors and Collaborators
University of Athens
Investigators
Principal Investigator: Phoebus N Madianos, PhD University of Athens
  More Information

Responsible Party: Spyros Kouris, Spyros Kouris, DIpDS, MClinDent, PhD Candidate, University of Athens
ClinicalTrials.gov Identifier: NCT01217281     History of Changes
Other Study ID Numbers: 143
First Submitted: October 6, 2010
First Posted: October 8, 2010
Last Update Posted: October 26, 2017
Last Verified: October 2017

Keywords provided by Spyros Kouris, University of Athens:
CKD, Renal, Chronic Kidney Disease, Periodontitis, Perio

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Periodontitis
Urologic Diseases
Renal Insufficiency
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases