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Periodontal Infection and Systemic Inflammation in Renal Patients (PeriRen)

This study has been completed.
Sponsor:
Collaborator:
National Institute of Dental and Craniofacial Research (NIDCR)
Information provided by (Responsible Party):
Efthimia Ioannidou, UConn Health
ClinicalTrials.gov Identifier:
NCT01094639
First received: March 23, 2010
Last updated: October 24, 2016
Last verified: October 2016
  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

Further study details as provided by UConn Health:

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


Enrollment: 52
Study Start Date: August 2009
Study Completion Date: August 2015
Primary Completion Date: July 2015 (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
SRP+oral hygiene
Procedure: Scaling root planing
Deep gum cleaning with local anesthesia

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.
  Eligibility

Ages Eligible for Study:   21 Years to 85 Years   (Adult, Senior)
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

Locations
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)
Investigators
Principal Investigator: Efthimia Ioannidou, DDS, MDS UConn Health
  More Information

Publications:

Responsible Party: Efthimia Ioannidou, Associate Professor, UConn Health
ClinicalTrials.gov Identifier: NCT01094639     History of Changes
Other Study ID Numbers: 10-092-2  K23DE018689 
Study First Received: March 23, 2010
Last Updated: October 24, 2016
Health Authority: United States: Institutional Review Board
Individual Participant Data  
Plan to Share IPD: Undecided

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

ClinicalTrials.gov processed this record on December 02, 2016