Periodontal Infection and Systemic Inflammation in Renal Patients

Chronic Kidney Disease Clinical Trial

— PeriRen  

Official title:

Periodontal Infection and Systemic Inflammation in Renal Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01094639
• Other study ID #: 10-092-2
• Secondary ID: K23DE018689
• Status: Completed
• Phase: N/A
• First received: March 23, 2010
• Last updated: October 24, 2016
• Start date: August 2009
• Est. completion date: August 2015

Study information

• Verified date: October 2016
• Source: UConn Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: August 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 85 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Inflammation
• Kidney Diseases
• Periodontitis
• Renal Insufficiency, Chronic

Intervention

Procedure:
• Scaling root planing
Deep gum cleaning with local anesthesia
• Supragingival Prophylaxis
Plaque removal

Locations

Country	Name	City	State
United States	University of Connecticut Health Center	Farmington	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
UConn Health	National Institute of Dental and Craniofacial Research (NIDCR)

Country where clinical trial is conducted

United States, 

References & Publications (8)

Araújo 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. — View 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. — View 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. — View 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. Review. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	2 months	No
Secondary	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	2 months	No