Status:

COMPLETED

Novel PAradigm to Improve Inflammatory Burden in ESRD (rePAIR): A Pilot and Feasibility Randomized Controlled Trial

Lead Sponsor:

UConn Health

Collaborating Sponsors:

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Conditions:

Chronic Periodontitis

End Stage Renal Disease

Eligibility:

All Genders

21+ years

Phase:

NA

Brief Summary

The goal of this project is to assess repeated and ongoing oral care and the way it may affect inflammation and quality of life in hemodialysis patients. Two treatment groups will be compared: * 1\) ...

Eligibility Criteria

Inclusion

  • Patient must be referred by nephrologist
  • Patient must be diagnosed with ESRD and on Hemodialysis
  • life expectancy more than one year
  • at least 21 years of age
  • 12 or more teeth
  • must meet the Periodontal diagnosis criteria (The diagnosis of periodontitis is based on the definition of moderate periodontitis with at least 2 sites with CAL≥4mm or at least 2 sites with PD≥5mm not on the same tooth (Page and Eke 2007).)

Exclusion

  • Anticipating a kidney transplant
  • AIDS
  • Active malignancy
  • Poor adherence to hemodialysis
  • Dementia
  • Currently prescribed anti-inflammatory medication
  • Temporary catheter for dialysis access
  • Gum disease treatment within the last year

Key Trial Info

Start Date :

November 7 2017

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

December 1 2020

Estimated Enrollment :

66 Patients enrolled

Trial Details

Trial ID

NCT03241511

Start Date

November 7 2017

End Date

December 1 2020

Last Update

June 5 2025

Active Locations (1)

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1

University of Connecticut Health Center

Farmington, Connecticut, United States, 06030-1710