PeRiodontal Treatment to Eliminate Minority Inequality and Rural Disparities in Stroke (PREMIERS): A Multicenter, Randomized, Controlled Study

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 In...

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Published inInternational journal of cerebrovascular disease and stroke Vol. 2; no. 2
Main Authors 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
Format Journal Article
LanguageEnglish
Published United States 2019
Subjects
Stroke Disparities
Periodontal Disease
Stroke
Stroke Prevention
Adaptive Randomization
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Summary: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.