Periodontal Infection and Systemic Inflammation in Renal Patients (PeriRen)

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2012 by University of Connecticut Health Center
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Efthimia Ioannidou, University of Connecticut Health Center
ClinicalTrials.gov Identifier:
NCT01094639
First received: March 23, 2010
Last updated: November 30, 2012
Last verified: November 2012
  Purpose

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 Intervention
Periodontitis
Chronic Kidney Disease
Procedure: Scaling root planing
Procedure: Supragingival Prophylaxis

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Periodontal Infection and Systemic Inflammation in Renal Patients

Resource links provided by NLM:


Further study details as provided by University of Connecticut Health Center:

Primary Outcome Measures:
  • Serum Interleukin-6 (IL-6) and C-reactive protein (CRP) levels [ Time Frame: 2 months ] [ Designated as safety issue: No ]
    IL-6 and CRP are markers of systemic inflammation and may improve at the end of gum treatment.


Secondary Outcome Measures:
  • Changes in periodontal (gum) clinical presentation and status [ Time Frame: 2 months ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 152
Study Start Date: August 2009
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Supragingival prophylaxis
Plaque removal
Procedure: Supragingival Prophylaxis
Plaque removal
Active Comparator: Scaling root planing Procedure: Scaling root planing
Deep gum cleaning with local anesthesia

  Eligibility

Ages Eligible for Study:   21 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT01094639

Contacts
Contact: Megyn Clement 860-679-4995

Locations
United States, Connecticut
University of Connecticut Health Center Recruiting
Farmington, Connecticut, United States, 06030-1710
Contact: Megyn Clement, DA    860-679-4995    mclement@uchc.edu   
Principal Investigator: Efthimia Ioannidou, DDS, MDS         
Sponsors and Collaborators
University of Connecticut Health Center
Investigators
Principal Investigator: Efthimia Ioannidou, DDS, MDS University of Connecticut Health Center
  More Information

Publications:
Responsible Party: Efthimia Ioannidou, Associate Professor, University of Connecticut Health Center
ClinicalTrials.gov Identifier: NCT01094639     History of Changes
Other Study ID Numbers: 10-092-2, K23DE018689
Study First Received: March 23, 2010
Last Updated: November 30, 2012
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on August 26, 2014