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

NCT03241511 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2025-06-05

No results posted yet for this 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.

Conditions

Interventions

OTHER

Test

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).

Sponsors & Collaborators

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

    collaborator NIH

  • UConn Health

    lead OTHER

Principal Investigators

  • Effie Ioannidou, DDS, MS · UConn Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-07
Primary Completion
2020-12-01
Completion
2020-12-01

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03241511 on ClinicalTrials.gov