Novel PAradigm to Improve Inflammatory Burden in ESRD (rePAIR): A Pilot and Feasibility Randomized Controlled Trial (rePAIR)
Chronic Periodontitis, End Stage Renal Disease
About this trial
This is an interventional treatment trial for Chronic Periodontitis focused on measuring Periodontitis, End Stage Renal Disease, Periodontal treatment
Eligibility 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
Sites / Locations
- University of Connecticut Health Center
Arms of the Study
Arm 1
Arm 2
Experimental
No Intervention
Test
Control
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.
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.