Novel PAradigm to improve Inflammatory burden in end stage Renal disease (rePAIR): study protocol for a randomized controlled trial

Abstract

BackgroundGiven the importance of inflammation as a predictor of poor outcomes in End Stage Renal Disease (ESRD), reductions in inflammatory biomarkers have been proposed as a critical target in this population. This study targets chronic periodontitis, an oral inflammatory disease of microbial etiology causing persistent inflammation in ESRD. Unlike the previously reported episodic periodontal interventions, we propose to control periodontal inflammation with a continuous maintenance and oral health behavior modifications. We hypothesize that this strategy will improve systemic inflammation and oxidative stress, oral health and quality of life within the 6-month observation period.MethodsThe rePAIR (novel PAradigm to improve Inflammatory burden in ESRD) study is a pilot and feasibility, parallel-arm, and randomized controlled clinical trial that will recruit 72 ESRD subjects with periodontitis in a model of computerized block randomization. This trial aims to compare the effect of standard-of-care vs. repeated non-surgical periodontal therapy on systemic and oral inflammatory burden. This trial will recruit ESRD adult patients with periodontitis older than 21 years old with a minimum of 12 teeth and no history of periodontal treatment within a year. The trial will examine serum C-reactive protein (CRP) (primary outcome) as a biomarker of inflammation as well as interleukin-6 (IL-6), F2 isofurans and F2 isoprostanes (secondary outcomes) and compare their difference between groups from baseline to 6 months. The trial will also compare the difference between groups in patient-centered and clinical oral outcomes from baseline to 6 months.DiscussionThe trial follows a rigorous and transparent study design capturing elements such as pre-specified eligibility criteria, pre-specified primary and secondary outcomes, detailed intervention description to allow replication, intervention random allocation and concealment, blinding in outcome assessment, appropriate sample size calculations, explanation of interim analysis, as per CONSORT Guidelines. Further, gender diversity is secured not only at recruitment but also throughout the trial and during the analysis. Therefore, treatment response outcomes will be examined per gender category. In order to manage anticipated problems, the protocol has included alternative approaches.Trial registrationClinicalTrials.gov, NCT03241511. Registered on 7 August 2017.Electronic supplementary materialThe online version of this article (10.1186/s13063-018-2760-y) contains supplementary material, which is available to authorized users.

Association between periodontitis and chronic kidney disease

“…In this direction, our group is in the process of completing a randomized controlled trial 125 aiming to assess the impact of a tailored non-surgical periodontal therapy protocol on periodontal and renal outcomes.…”

“…Second, although studies have examined the effects of non‐surgical periodontal therapy in patients with periodontitis undergoing in‐center hemodialysis and/or peritoneal dialysis, no studies have explored non‐surgical periodontal therapy approaches tailored to chronic kidney disease/end‐stage kidney disease populations. In this direction, our group is in the process of completing a randomized controlled trial 125 aiming to assess the impact of a tailored non‐surgical periodontal therapy protocol on periodontal and renal outcomes.…”