Periodontal Infection and Systemic Inflammation in Renal Patients

Not Applicable

Completed

• Conditions: Chronic Kidney Disease; Periodontitis
• Interventions: Procedure: Scaling root planing; Procedure: Supragingival Prophylaxis

• Registration Number: NCT01094639
• Lead Sponsor: UConn Health

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 Timeline

• Study Start: 2009-08
• Study First Submitted: 2010-03-23
• Study First Submitted QC: 2010-03-25
• Study First Posted: 2010-03-29
• Primary Completion: 2015-07
• Study Completion: 2015-08
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-24
• Last Update Posted: 2016-10-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Scaling root planing	Scaling root planing	SRP+oral hygiene
Supragingival prophylaxis	Supragingival Prophylaxis	Plaque removal

Primary Outcome Measures

Name	Time	Method
Serum Interleukin-6 (IL-6) and C-reactive protein (CRP) levels	2 months	IL-6 and CRP are markers of systemic inflammation and may improve at the end of gum treatment.

Secondary Outcome Measures

Name	Time	Method
Changes in periodontal (gum) clinical presentation and status	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

Trial Locations

Locations (1)

University of Connecticut Health Center; 🇺🇸 Farmington, Connecticut, United States