Periodontal Infection and Systemic Inflammation in Renal Patients

Study Overview
=================
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.

Official Title
-----------------
Periodontal Infection and Systemic Inflammation in Renal Patients

Conditions
-----------------
Periodontitis, Chronic Kidney Disease

Intervention / Treatment
-----------------
* Procedure: Scaling root planing
* Procedure: Supragingival Prophylaxis


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 85 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Supragingival prophylaxis<br>Plaque removal | Procedure: Supragingival Prophylaxis<br>* Plaque removal<br>|
| Active Comparator: Scaling root planing<br>SRP+oral hygiene | Procedure: Scaling root planing<br>* Deep gum cleaning with local anesthesia<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |