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OpenTrials
Completed

NCT Number: NCT01094639

Periodontal Infection and Systemic Inflammation in Renal Patients

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.

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Key information

Conditions

Periodontitis Chronic Disease Chronic Kidney Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Mouth Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Periodontal Diseases Renal Insufficiency Renal Insufficiency, Chronic Stomatognathic Diseases Urogenital Diseases Urologic Diseases

Age range

21 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Connecticut Health Center

Farmington, Connecticut, 06030-1710, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Scaling root planing

Procedure

Deep gum cleaning with local anesthesia

Supragingival Prophylaxis

Procedure

Plaque removal

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

UConn Health

Other

Collaborators

  • National Institute of Dental and Craniofacial Research (NIDCR)

Registry information

Acronym: PeriRen

Important dates

Study start
2009
Primary completion
2015
Study completion
2015
First posted
Mar 29, 2010
Registry last updated
Oct 25, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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