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Trial record 4 of 6 for:    gum disease | Recruiting Studies | 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 : September 25, 2018
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Efthimia Ioannidou, UConn Health

August 2, 2017
August 7, 2017
September 25, 2018
November 7, 2017
April 2019   (Final data collection date for primary outcome measure)
Serum CRP [ Time Frame: 6 months ]
Inflammatory markers
  • Serum CRP and IL-6 [ Time Frame: 6 months ]
    Inflammatory markers
  • OHIP-14 [ Time Frame: 6-months ]
    Patient Centered outcomes
Complete list of historical versions of study NCT03241511 on ClinicalTrials.gov Archive Site
  • Probing depth PD [ Time Frame: 6 months ]
    Clinical periodontal outcome
  • Clinical attachment levels CAL [ Time Frame: 6 months ]
    Clinical periodontal outcome
  • OHIP-14 [ Time Frame: 6 months ]
    Patient Centered Outcome
  • Serum IL-6 [ Time Frame: 6 months ]
    Inflammatory Marker
  • F2 isoprostanes [ Time Frame: 6 months ]
    Oxidative Stress Marker
  • isofurans [ Time Frame: 6 months ]
    Oxidative Stress Marker
  • Probing depth PD [ Time Frame: 6 months ]
    Clinical periodontal outcome
  • Clinical attachment levels CAL [ Time Frame: 6 months ]
    Clinical periodontal outcome
Not Provided
Not Provided
 
Novel PAradigm to Improve Inflammatory Burden in ESRD (rePAIR): A Pilot and Feasibility Randomized Controlled Trial
Pilot and Feasibility Clinical Research Grants in Kidney or Urologic Diseases (R21)

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.

Not Provided
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Chronic Periodontitis
  • End Stage Renal Disease
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).
  • 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.
    Intervention: Other: Test
  • 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.
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
90
Same as current
April 2019
April 2019   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
Gender Based Eligibility: Yes
21 Years and older   (Adult, Older Adult)
No
Contact: Megyn Clement, CCRP 860-679-4995 mclement@uchc.edu
Contact: Sharon Sternberg, RDH 860-679-4995 ssternberg@uchc.edu
United States
 
 
NCT03241511
1R21DK108076-01( U.S. NIH Grant/Contract )
R21DK108076 ( U.S. NIH Grant/Contract )
No
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
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
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: 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.
Efthimia Ioannidou, UConn Health
UConn Health
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Principal Investigator: Effie Ioannidou, DDS, MS UConn Health
UConn Health
September 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP