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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2010 by University of Athens.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Athens
ClinicalTrials.gov Identifier:
NCT01217281
First received: October 6, 2010
Last updated: October 7, 2010
Last verified: April 2010
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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 University of Athens:

Primary Outcome Measures:
  • eGFR [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    estimated Glomerular Filtration Rate


Secondary Outcome Measures:
  • Cystatin C [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Surrogate marker for filtration rate

  • CRP [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • d-8-iso prostaglandin F2a [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Level of IgG antibodies in serum against periodontal pathogens [ Time Frame: 6 months ] [ Designated as safety issue: No ]

    Serum samples will be screened for the presence of IgG antibodies against the below mentioned periodontal pathogens, using the "checkerboard immonoblotting" 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 ] [ Designated as safety issue: No ]
    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 bacteia: 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

  • Il-6 [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • TNF-α [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: June 2010
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: July 2012 (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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01217281

Contacts
Contact: Spyros Kouris, MClinDent +30 210 806899 spkouris@dent.uoa.gr
Contact: Phoebus N Madianos, PhD +30 2107461181 pmadian@dent.uoa.gr

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

No publications provided

Responsible Party: Ass. Prof. Phoebus N. Madianos, University of Athens
ClinicalTrials.gov Identifier: NCT01217281     History of Changes
Other Study ID Numbers: 143
Study First Received: October 6, 2010
Last Updated: October 7, 2010
Health Authority: Greece: Ethics Committee

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

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

ClinicalTrials.gov processed this record on August 27, 2014