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Periodontal Infection and Systemic Inflammation in Renal Patients (PeriRen)

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. Identifier: NCT01094639
Recruitment Status : Completed
First Posted : March 29, 2010
Last Update Posted : October 25, 2016
National Institute of Dental and Craniofacial Research (NIDCR)
Information provided by (Responsible Party):
Efthimia Ioannidou, UConn Health

Brief Summary:
The purpose of this study is to examine the role of gum disease in affecting the long term prognosis of renal patients. This disease if untreated causes inflammatory response throughout the body. If the subject has gum disease, he/she will be randomly assigned to one of the two treatment groups. The study investigates what happens to inflammatory markers in blood and saliva after you are treated for gum disease.

Condition or disease Intervention/treatment Phase
Periodontitis Chronic Kidney Disease Procedure: Scaling root planing Procedure: Supragingival Prophylaxis Not Applicable

Detailed Description:

The main goal of this project was to explore the contribution of chronic periodontitis to systemic inflammation in Chronic Kidney Disease (CKD). To achieve this goal, the project had two specific objectives:

  1. a) To compare the prevalence of periodontal infection between CKD and non-CKD populations and b) to explore the association between the presence of periodontal infection and the uremic status of CKD patients.
  2. a) To assess the levels of systemic inflammatory markers, IL-6 and CRP in the presence or absence of periodontal infection in CKD and b) to compare the serum IL-6 and CRP levels in response to periodontal intervention.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Periodontal Infection and Systemic Inflammation in Renal Patients
Study Start Date : August 2009
Actual Primary Completion Date : July 2015
Actual Study Completion Date : August 2015

Arm Intervention/treatment
Placebo Comparator: Supragingival prophylaxis
Plaque removal
Procedure: Supragingival Prophylaxis
Plaque removal

Active Comparator: Scaling root planing
SRP+oral hygiene
Procedure: Scaling root planing
Deep gum cleaning with local anesthesia

Primary Outcome Measures :
  1. Serum Interleukin-6 (IL-6) and C-reactive protein (CRP) levels [ Time Frame: 2 months ]
    IL-6 and CRP are markers of systemic inflammation and may improve at the end of gum treatment.

Secondary Outcome Measures :
  1. Changes in periodontal (gum) clinical presentation and status [ Time Frame: 2 months ]
    For the secondary outcome, periodontal variables such as bleeding on probing, probing depth (the depth of the gum sulcus around the tooth), and bacterial plaque score will be evaluated to assess the effectiveness of the intervention and the compliance of the patients

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • dental subjects with periodontitis,
  • at least 10 teeth
  • no periodontal (gum) treatment for the last year,
  • no antibiotic for the last 4 months,
  • no vascular access infection.

Exclusion Criteria:

  • smokers

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 identifier (NCT number): NCT01094639

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United States, Connecticut
University of Connecticut Health Center
Farmington, Connecticut, United States, 06030-1710
Sponsors and Collaborators
UConn Health
National Institute of Dental and Craniofacial Research (NIDCR)
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Principal Investigator: Efthimia Ioannidou, DDS, MDS UConn Health

Publications of Results:
Other Publications:
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Responsible Party: Efthimia Ioannidou, Associate Professor, UConn Health Identifier: NCT01094639    
Other Study ID Numbers: 10-092-2
K23DE018689 ( U.S. NIH Grant/Contract )
First Posted: March 29, 2010    Key Record Dates
Last Update Posted: October 25, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Pathologic Processes
Urologic Diseases
Renal Insufficiency
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases