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Trial record 22 of 49 for:    gum disease AND oral | NIH

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.
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

Tracking Information
First Submitted Date  ICMJE March 23, 2010
First Posted Date  ICMJE March 29, 2010
Last Update Posted Date October 25, 2016
Study Start Date  ICMJE August 2009
Actual Primary Completion Date July 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 25, 2010)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01094639 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 25, 2010)
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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Periodontal Infection and Systemic Inflammation in Renal Patients
Official Title  ICMJE Periodontal Infection and Systemic Inflammation in Renal Patients
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Periodontitis
  • Chronic Kidney Disease
Intervention  ICMJE
  • Procedure: Scaling root planing
    Deep gum cleaning with local anesthesia
  • Procedure: Supragingival Prophylaxis
    Plaque removal
Study Arms  ICMJE
  • Placebo Comparator: Supragingival prophylaxis
    Plaque removal
    Intervention: Procedure: Supragingival Prophylaxis
  • Active Comparator: Scaling root planing
    SRP+oral hygiene
    Intervention: Procedure: Scaling root planing
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 24, 2016)
52
Original Estimated Enrollment  ICMJE
 (submitted: March 25, 2010)
152
Actual Study Completion Date  ICMJE August 2015
Actual Primary Completion Date July 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01094639
Other Study ID Numbers  ICMJE 10-092-2
K23DE018689 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Efthimia Ioannidou, UConn Health
Study Sponsor  ICMJE UConn Health
Collaborators  ICMJE National Institute of Dental and Craniofacial Research (NIDCR)
Investigators  ICMJE
Principal Investigator: Efthimia Ioannidou, DDS, MDS UConn Health
PRS Account UConn Health
Verification Date October 2016

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