Trivedi Ruchir, Fares George, Nunez Victoria Barany, Campbell Ryan, Clement Megyn, Burleson Joseph, Himmelfarb Jonathan, Ioannidou Effie
Division of Nephrology, UCONN Health, Farmington, CT, USA.
Bay State Medical Center, Springfield, MA, USA.
Trials. 2018 Jul 11;19(1):370. doi: 10.1186/s13063-018-2760-y.
Given 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.
The 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.
The 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.
ClinicalTrials.gov, NCT03241511 . Registered on 7 August 2017.
鉴于炎症作为终末期肾病（ESRD）不良预后预测指标的重要性，降低炎症生物标志物已被提议作为该人群的关键目标。本研究针对慢性牙周炎，这是一种由微生物病因引起的口腔炎症性疾病，会在ESRD患者中导致持续炎症。与先前报道的间歇性牙周干预不同，我们提议通过持续的维护和口腔健康行为改变来控制牙周炎症。我们假设该策略将在6个月的观察期内改善全身炎症和氧化应激、口腔健康及生活质量。
rePAIR（改善ESRD炎症负担的新型范式）研究是一项试点及可行性、平行组、随机对照临床试验，将采用计算机化区组随机化模型招募72名患有牙周炎的ESRD受试者。该试验旨在比较标准治疗与重复非手术牙周治疗对全身和口腔炎症负担的影响。本试验将招募年龄超过21岁、至少有12颗牙齿且在一年内无牙周治疗史的患有牙周炎的ESRD成年患者。该试验将检测血清C反应蛋白（CRP）（主要结局）作为炎症生物标志物以及白细胞介素-6（IL-6）、F2异呋喃和F2异前列腺素（次要结局），并比较从基线到6个月各治疗组之间的差异。该试验还将比较从基线到6个月各治疗组在以患者为中心的和临床口腔结局方面的差异。
该试验遵循严格且透明的研究设计，涵盖了如预先指定的纳入标准、预先指定的主要和次要结局、详细的干预描述以允许重复、干预随机分配和隐藏、结局评估中的盲法、适当的样本量计算、中期分析的解释等要素，符合CONSORT指南。此外，不仅在招募时确保性别多样性，而且在整个试验过程及分析期间都予以保障。因此，将按性别类别检查治疗反应结局。为了应对预期问题，方案中纳入了替代方法。
ClinicalTrials.gov，NCT03241511。于2017年8月7日注册。
