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NCT03241511 · ClinicalTrials.gov registry record · NA

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

A NA study, sponsored by UConn Health.

Completed
Registry status
NA
Development phase
66
Enrollment target

NCT03241511 is a NA study that has completed, run by UConn Health. The registered enrollment target is 66 participants.

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The verdict

NCT03241511, a NA study, has completed, sponsored by UConn Health.

COMPLETED
Registry status
NA
Development phase
66 participants
Enrollment target

Study 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.

Interventions

  • OTHER Test

Trial Details

FieldValue
Enrollment Target 66 participants
Start Date 2017-11-07
Est. Completion 2020-12-01
Phase NA

Sponsor

UConn Health

178 total trials

What the Registry Record Tells You About NCT03241511

The ClinicalTrials.gov registry entry for NCT03241511 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 66 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is UConn Health, which has 178 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which Test is the first listed.

NCT03241511 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT03241511 about?

NCT03241511 is a clinical study titled "Novel PAradigm to Improve Inflammatory Burden in ESRD (rePAIR): A Pilot and Feasibility Randomized Controlled Trial". 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 appointm...

What is the current status of trial NCT03241511?

This trial is currently completed. It is a NA study. The enrollment target is 66 participants. The study started on 2017-11-07. Estimated completion is 2020-12-01.

What interventions are being tested in trial NCT03241511?

The interventions under investigation include: Test (OTHER).

Who is sponsoring clinical trial NCT03241511?

This trial is sponsored by UConn Health, which has 178 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.