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

Primary Purpose

Chronic Periodontitis, End Stage Renal Disease

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Test
Sponsored by
UConn Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Periodontitis focused on measuring Periodontitis, End Stage Renal Disease, Periodontal treatment

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Connecticut Health Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Test

Control

Arm Description

Briefly, treatment sessions will include oral hygiene behavioral modification and scaling and root planning (removing the bacterial biofilm and calculus below the gum line) in order to eliminate etiologic factors and control periodontal inflammation. Once the treatment sessions are completed, the patients will enter the maintenance phase and will be followed for 6 months. In this phase, the patients will receive systematic and repeated supportive periodontal treatment (tooth cleanings above the gum line with re-enforcement of oral hygiene). Outcomes will be assessed at 2-, 4-, and 6-months. Throughout the course of the study, additional dental needs will be addressed with immediate referral to the subject's general dentist or clinics at the University of Connecticut.

The Control arm will receive only a single treatment session without maintenance sessions (see visit Table in Human Subject Protection section). Outcomes will be assessed at 2-, 4-, and 6-months.

Outcomes

Primary Outcome Measures

Serum CRP
Inflammatory markers

Secondary Outcome Measures

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

Full Information

First Posted
August 2, 2017
Last Updated
January 29, 2021
Sponsor
UConn Health
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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1. Study Identification

Unique Protocol Identification Number
NCT03241511
Brief Title
Novel PAradigm to Improve Inflammatory Burden in ESRD (rePAIR): A Pilot and Feasibility Randomized Controlled Trial
Acronym
rePAIR
Official Title
Pilot and Feasibility Clinical Research Grants in Kidney or Urologic Diseases (R21)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Unknown status
Study Start Date
November 7, 2017 (Actual)
Primary Completion Date
April 2021 (Anticipated)
Study Completion Date
April 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
UConn Health
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Periodontitis, End Stage Renal Disease
Keywords
Periodontitis, End Stage Renal Disease, Periodontal treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Test
Arm Type
Experimental
Arm Description
Briefly, treatment sessions will include oral hygiene behavioral modification and scaling and root planning (removing the bacterial biofilm and calculus below the gum line) in order to eliminate etiologic factors and control periodontal inflammation. Once the treatment sessions are completed, the patients will enter the maintenance phase and will be followed for 6 months. In this phase, the patients will receive systematic and repeated supportive periodontal treatment (tooth cleanings above the gum line with re-enforcement of oral hygiene). Outcomes will be assessed at 2-, 4-, and 6-months. Throughout the course of the study, additional dental needs will be addressed with immediate referral to the subject's general dentist or clinics at the University of Connecticut.
Arm Title
Control
Arm Type
No Intervention
Arm Description
The Control arm will receive only a single treatment session without maintenance sessions (see visit Table in Human Subject Protection section). Outcomes will be assessed at 2-, 4-, and 6-months.
Intervention Type
Other
Intervention Name(s)
Test
Intervention Description
Briefly, treatment sessions will include oral hygiene behavioral modification and scaling and root planning (removing the bacterial biofilm and calculus below the gum line) in order to eliminate etiologic factors and control periodontal inflammation. Once the treatment sessions are completed, the patients will enter the maintenance phase and will be followed for 6 months. In this phase, the patients will receive systematic supportive periodontal treatment (tooth cleanings above the gum line with re-enforcement of oral hygiene).
Primary Outcome Measure Information:
Title
Serum CRP
Description
Inflammatory markers
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Probing depth PD
Description
Clinical periodontal outcome
Time Frame
6 months
Title
Clinical attachment levels CAL
Description
Clinical periodontal outcome
Time Frame
6 months
Title
OHIP-14
Description
Patient Centered Outcome
Time Frame
6 months
Title
Serum IL-6
Description
Inflammatory Marker
Time Frame
6 months
Title
F2 isoprostanes
Description
Oxidative Stress Marker
Time Frame
6 months
Title
isofurans
Description
Oxidative Stress Marker
Time Frame
6 months

10. Eligibility

Sex
All
Gender Based
Yes
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Effie Ioannidou, DDS, MS
Organizational Affiliation
UConn Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Connecticut Health Center
City
Farmington
State/Province
Connecticut
ZIP/Postal Code
06030-1710
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Once the study is completed, the data will be available without cost to researchers. As part of the registration process, users must agree to the conditions of use governing access to the public release data (e.g., data destruction after analyses are complete, proper acknowledgement of data resources). Data will be provided at no cost and all data will be de-identified prior to sharing.
IPD Sharing Time Frame
The data will available after the completion of the study
IPD Sharing Access Criteria
As part of the registration process, users must agree to the conditions of use governing access to the public release data (e.g., data destruction after analyses are complete, proper acknowledgement of data resources). Data will be provided at no cost and all data will be de-identified prior to sharing.
Citations:
PubMed Identifier
29996883
Citation
Trivedi R, Fares G, Nunez VB, Campbell R, Clement M, Burleson J, Himmelfarb J, Ioannidou E. Novel PAradigm to improve Inflammatory burden in end stage Renal disease (rePAIR): study protocol for a randomized controlled trial. Trials. 2018 Jul 11;19(1):370. doi: 10.1186/s13063-018-2760-y.
Results Reference
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Novel PAradigm to Improve Inflammatory Burden in ESRD (rePAIR): A Pilot and Feasibility Randomized Controlled Trial

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