Redd Kolby T, Phillips S T, McMillian Brittiny, Giamberardino Lauren, Hardin James, Glover Saundra, Merchant Anwar, Susin Christiano, Beck James D, Offenbacher Steven, Sen Souvik
Department of Neurology, University of South Carolina, Columbia, South Carolina, USA.
Arnold School of Public Health, University of South Carolina, Columbia, South Carolina, USA.
Int J Cerebrovasc Dis Stroke. 2019;2(2). Epub 2019 Nov 8.
Stroke remains more common in the "buckle" of the stroke belt, and disproportionately impacts African Americans. The reasons for this racial disparity are poorly understood and are not entirely explained by traditional stroke risk factors. The PeRiodontal treatment to Eliminate Minority InEquality and Rural disparities in Stroke (PREMIERS) study will evaluate the effect of periodontal treatment on recurrent vascular events and stroke risk factors among ischemic stroke and transient ischemic attack patients.
Eligibility for the trial includes a non-disabling stroke confirmed by neuroimaging or Transient Ischemic Attack (TIA), being at least 18 years of age, having ≥ 5 natural teeth with ≥ 2 interproximal sites with ≥ 4 mm of clinical attachment loss and at least 2 sites with probing depth of ≥ 5 mm, and who are able to provide written informed consent. Within 90 days of the index event, patients are randomly assigned to intensive or initial standard cycle of supragingival mechanical scaling, polishing, and oral health instruction and followed for 1 year. The primary outcome is a composite of death, myocardial infarction and stroke or TIA. Secondary outcomes include A1C, fasting lipid profile, triglycerides, high sensitivity C-reactive protein, carotid intimal medial thickness, and blood pressure. A five year enrollment period followed by an addition one year of follow-up is planned.
中风在中风带的“扣状区域”更为常见，对非裔美国人的影响尤为严重。这种种族差异的原因尚不清楚，传统的中风风险因素也无法完全解释。消除中风中少数群体不平等和农村差异的牙周治疗（PREMIERS）研究将评估牙周治疗对缺血性中风和短暂性脑缺血发作患者复发性血管事件和中风风险因素的影响。
该试验的入选标准包括经神经影像学证实的非致残性中风或短暂性脑缺血发作（TIA）、年龄至少18岁、有≥5颗天然牙且≥2个邻面部位有≥4mm的临床附着丧失以及至少2个探诊深度≥5mm的部位，并且能够提供书面知情同意书。在索引事件发生后的90天内，患者被随机分配到龈上机械洁治、抛光和口腔健康指导的强化或初始标准周期，并随访1年。主要结局是死亡、心肌梗死、中风或TIA的复合结局。次要结局包括糖化血红蛋白（A1C）、空腹血脂谱、甘油三酯、高敏C反应蛋白、颈动脉内膜中层厚度和血压。计划进行为期五年的入组期，随后再进行一年的随访。
