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

Not Applicable

Completed

• Conditions: End Stage Renal Disease; Chronic Periodontitis

• Registration Number: NCT03241511
• Lead Sponsor: UConn Health

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) ongoing and repeated gum disease therapy including deep tooth cleaning followed by multiple appointments of maintenance

* 2) single session of gum disease therapy with only one session of deep tooth cleaning Samples of blood will be obtained for study to examine the changes of inflammatory substances in the blood as a result of the two different gum disease treatments. Also, a 14-question survey will be discussed with you to assess oral health related quality of life (OHIP-14) and the way it is affected by oral care.

For this project, four dialysis centers will be randomly assigned to either of the treatment groups #1 or #2 prior to your enrollment. For this purpose, there are two distinct consent forms explaining the visits, procedures and risks of the two treatment groups #1 or #2. As a result, all participants in the same dialysis center will belong to the same treatment group (either #1 or #2) and presented with the corresponding consent form.

This dialysis center has been randomized to treatment group # 1; therefore you will receive ongoing and repeated gum disease therapy including deep tooth cleaning followed by multiple appointments of maintenance.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-08-02
• Study First Submitted QC: 2017-08-02
• Study First Posted: 2017-08-07
• Study Start: 2017-11-07
• Primary Completion: 2020-12-01
• Study Completion: 2020-12-01
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-02
• Last Update Posted: 2025-06-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

Inclusion Criteria

• 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 Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Serum CRP	6 months	Inflammatory markers

Secondary Outcome Measures

Name	Time	Method
Serum IL-6	6 months	Inflammatory Marker
Probing depth PD	6 months	Clinical periodontal outcome
Clinical attachment levels CAL	6 months	Clinical periodontal outcome
OHIP-14	6 months	Patient Centered Outcome
F2 isoprostanes	6 months	Oxidative Stress Marker
isofurans	6 months	Oxidative Stress Marker

Trial Locations

Locations (1)

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