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Trial record 21 of 46 for:    gum disease | NIH

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

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ClinicalTrials.gov Identifier: NCT03241511
Recruitment Status : Recruiting
First Posted : August 7, 2017
Last Update Posted : May 14, 2018
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Efthimia Ioannidou, 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.


Condition or disease Intervention/treatment Phase
Chronic Periodontitis End Stage Renal Disease Other: Test Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pilot and Feasibility Clinical Research Grants in Kidney or Urologic Diseases (R21)
Actual Study Start Date : November 7, 2017
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : April 2019

Arm Intervention/treatment
Experimental: 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 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.
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).

No Intervention: Control
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.



Primary Outcome Measures :
  1. Serum CRP [ Time Frame: 6 months ]
    Inflammatory markers


Secondary Outcome Measures :
  1. Probing depth PD [ Time Frame: 6 months ]
    Clinical periodontal outcome

  2. Clinical attachment levels CAL [ Time Frame: 6 months ]
    Clinical periodontal outcome

  3. OHIP-14 [ Time Frame: 6 months ]
    Patient Centered Outcome

  4. Serum IL-6 [ Time Frame: 6 months ]
    Inflammatory Marker

  5. F2 isoprostanes [ Time Frame: 6 months ]
    Oxidative Stress Marker

  6. isofurans [ Time Frame: 6 months ]
    Oxidative Stress Marker



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03241511


Contacts
Contact: Megyn Clement, CCRP 860-679-4995 mclement@uchc.edu
Contact: Sharon Sternberg, RDH 860-679-4995 ssternberg@uchc.edu

Locations
United States, Connecticut
University of Connecticut Health Center Recruiting
Farmington, Connecticut, United States, 06030-1710
Contact: Megyn Clement, DA    860-679-4995    mclement@uchc.edu   
Principal Investigator: Effie Ioannidou, DDS, MDS         
Sponsors and Collaborators
UConn Health
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Principal Investigator: Effie Ioannidou, DDS, MS UConn Health

Responsible Party: Efthimia Ioannidou, Associate Professor, Director, DCRC, School of Dental Medicine, UConn Health
ClinicalTrials.gov Identifier: NCT03241511     History of Changes
Other Study ID Numbers: 1R21DK108076-01 ( U.S. NIH Grant/Contract )
R21DK108076 ( U.S. NIH Grant/Contract )
First Posted: August 7, 2017    Key Record Dates
Last Update Posted: May 14, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: The data will available after the completion of the study
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.
URL: http://

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Efthimia Ioannidou, UConn Health:
Periodontitis, End Stage Renal Disease, Periodontal treatment

Additional relevant MeSH terms:
Kidney Diseases
Kidney Failure, Chronic
Periodontitis
Chronic Periodontitis
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases