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Completed

NCT Number: NCT03241511

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 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.

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Key information

Conditions

Chronic Periodontitis Chronic Disease Disease Attributes End Stage Renal Disease Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Mouth Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Periodontal Diseases Periodontitis Renal Insufficiency Renal Insufficiency, Chronic Stomatognathic Diseases Urogenital Diseases Urologic Diseases

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Connecticut Health Center

Farmington, Connecticut, 06030-1710, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Test

Other

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 outcomes

  1. Serum CRP

    Time frame: 6 months

    Inflammatory markers

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

UConn Health

Other

Collaborators

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

Registry information

Official study title

Pilot and Feasibility Clinical Research Grants in Kidney or Urologic Diseases (R21)

Acronym: rePAIR

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Aug 7, 2017
Registry last updated
Jun 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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