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

Study Overview
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Brief Summary
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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.

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

Conditions
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Chronic Periodontitis, End Stage Renal Disease

Intervention / Treatment
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* Other: Test


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test<br>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<br>* 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).<br>|
| No Intervention: Control<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum CRP | Inflammatory markers | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Probing depth PD | Clinical periodontal outcome | 6 months | 
| Clinical attachment levels CAL | Clinical periodontal outcome | 6 months | 
| OHIP-14 | Patient Centered Outcome | 6 months | 
| Serum IL-6 | Inflammatory Marker | 6 months | 
| F2 isoprostanes | Oxidative Stress Marker | 6 months | 
| isofurans | Oxidative Stress Marker | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Periodontitis, End Stage Renal Disease, Periodontal treatment