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Periodontal Infection and Systemic Inflammation in Renal Patients (PeriRen)

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

March 23, 2010
March 29, 2010
October 25, 2016
August 2009
July 2015   (Final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01094639 on ClinicalTrials.gov Archive Site
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
Same as current
Not Provided
Not Provided
 
Periodontal Infection and Systemic Inflammation in Renal Patients
Periodontal Infection and Systemic Inflammation in Renal Patients
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.

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.
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
  • Periodontitis
  • Chronic Kidney Disease
  • Procedure: Scaling root planing
    Deep gum cleaning with local anesthesia
  • Procedure: Supragingival Prophylaxis
    Plaque removal
  • Placebo Comparator: Supragingival prophylaxis
    Plaque removal
    Intervention: Procedure: Supragingival Prophylaxis
  • Active Comparator: Scaling root planing
    SRP+oral hygiene
    Intervention: Procedure: Scaling root planing

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
52
152
August 2015
July 2015   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
21 Years to 85 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01094639
10-092-2
K23DE018689 ( U.S. NIH Grant/Contract )
Yes
Not Provided
Plan to Share IPD: Undecided
Efthimia Ioannidou, UConn Health
UConn Health
National Institute of Dental and Craniofacial Research (NIDCR)
Principal Investigator: Efthimia Ioannidou, DDS, MDS UConn Health
UConn Health
October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP