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Periodontal Infection and Systemic Inflammation in Renal Patients (PeriRen)

Primary Purpose

Periodontitis, Chronic Kidney Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Scaling root planing
Supragingival Prophylaxis
Sponsored by
UConn Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Periodontitis

Eligibility Criteria

21 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Connecticut Health Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Supragingival prophylaxis

Scaling root planing

Arm Description

Plaque removal

SRP+oral hygiene

Outcomes

Primary Outcome Measures

Serum Interleukin-6 (IL-6) and C-reactive protein (CRP) levels
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
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

Full Information

First Posted
March 23, 2010
Last Updated
October 24, 2016
Sponsor
UConn Health
Collaborators
National Institute of Dental and Craniofacial Research (NIDCR)
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1. Study Identification

Unique Protocol Identification Number
NCT01094639
Brief Title
Periodontal Infection and Systemic Inflammation in Renal Patients
Acronym
PeriRen
Official Title
Periodontal Infection and Systemic Inflammation in Renal Patients
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
August 2009 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
August 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
UConn Health
Collaborators
National Institute of Dental and Craniofacial Research (NIDCR)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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: 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontitis, Chronic Kidney Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Supragingival prophylaxis
Arm Type
Placebo Comparator
Arm Description
Plaque removal
Arm Title
Scaling root planing
Arm Type
Active Comparator
Arm Description
SRP+oral hygiene
Intervention Type
Procedure
Intervention Name(s)
Scaling root planing
Intervention Description
Deep gum cleaning with local anesthesia
Intervention Type
Procedure
Intervention Name(s)
Supragingival Prophylaxis
Intervention Description
Plaque removal
Primary Outcome Measure Information:
Title
Serum Interleukin-6 (IL-6) and C-reactive protein (CRP) levels
Description
IL-6 and CRP are markers of systemic inflammation and may improve at the end of gum treatment.
Time Frame
2 months
Secondary Outcome Measure Information:
Title
Changes in periodontal (gum) clinical presentation and status
Description
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
Time Frame
2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Efthimia Ioannidou, DDS, MDS
Organizational Affiliation
UConn Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Connecticut Health Center
City
Farmington
State/Province
Connecticut
ZIP/Postal Code
06030-1710
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
17032104
Citation
Ioannidou E, Malekzadeh T, Dongari-Bagtzoglou A. Effect of periodontal treatment on serum C-reactive protein levels: a systematic review and meta-analysis. J Periodontol. 2006 Oct;77(10):1635-42. doi: 10.1902/jop.2006.050443.
Results Reference
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PubMed Identifier
20412451
Citation
Ioannidou E, Shaqman M, Burleson J, Dongari-Bagtzoglou A. Periodontitis case definition affects the association with renal function in kidney transplant recipients. Oral Dis. 2010 Oct;16(7):636-42. doi: 10.1111/j.1601-0825.2010.01665.x.
Results Reference
background
PubMed Identifier
21940520
Citation
Ioannidou E, Swede H, Dongari-Bagtzoglou A. Periodontitis predicts elevated C-reactive protein levels in chronic kidney disease. J Dent Res. 2011 Dec;90(12):1411-5. doi: 10.1177/0022034511423394. Epub 2011 Sep 22.
Results Reference
background
PubMed Identifier
25984952
Citation
Hong BY, Furtado Araujo MV, Strausbaugh LD, Terzi E, Ioannidou E, Diaz PI. Microbiome profiles in periodontitis in relation to host and disease characteristics. PLoS One. 2015 May 18;10(5):e0127077. doi: 10.1371/journal.pone.0127077. eCollection 2015. Erratum In: PLoS One. 2016;11(2):e0148893.
Results Reference
background
PubMed Identifier
21422478
Citation
Ioannidou E, Swede H. Disparities in periodontitis prevalence among chronic kidney disease patients. J Dent Res. 2011 Jun;90(6):730-4. doi: 10.1177/0022034511402209. Epub 2011 Mar 21.
Results Reference
result
PubMed Identifier
22775287
Citation
Ioannidou E, Hall Y, Swede H, Himmelfarb J. Periodontitis associated with chronic kidney disease among Mexican Americans. J Public Health Dent. 2013 Spring;73(2):112-9. doi: 10.1111/j.1752-7325.2012.00350.x. Epub 2012 Jul 6.
Results Reference
result
PubMed Identifier
26055269
Citation
Araujo MV, Hong BY, Fava PL, Khan S, Burleson JA, Fares G, Samson W, Strausbaugh LD, Diaz PI, Ioannidou E. End stage renal disease as a modifier of the periodontal microbiome. BMC Nephrol. 2015 Jun 9;16:80. doi: 10.1186/s12882-015-0081-x.
Results Reference
result
PubMed Identifier
24215204
Citation
Ioannidou E, Swede H, Fares G, Himmelfarb J. Tooth loss strongly associates with malnutrition in chronic kidney disease. J Periodontol. 2014 Jul;85(7):899-907. doi: 10.1902/jop.2013.130347. Epub 2013 Nov 11.
Results Reference
result

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Periodontal Infection and Systemic Inflammation in Renal Patients

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