PeRiodontal Treatment to Eliminate Minority InEquality and Rural Disparities in Stroke

Stroke is the fourth leading cause of death and the leading cause of long-term adult disability in the United States. Stroke remains more common in North and South Carolina, part of 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 REGARDS study found that tooth loss (a surrogate of periodontal disease) was more common among African Americans than whites and was associated with higher stroke risk and stroke risk factors. Given this result, REGARDS investigators postulated that periodontal disease may be contributing to the racial disparity in stroke. Additional data from this study shows that low socioeconomic status (SES) is associated with greater tooth loss, both of which are seen more frequently in African Americans as opposed to their white counterparts. Considering these factors, a question arises about whether low SES, race, a combination of the two, and/or traditional risk factors contribute to tooth loss, periodontal disease, and recurrent vascular events. Howard and colleagues suggest in their paper that race is the predominant factor contributing to vascular events after adjustment for SES and risk factors. If the predisposition exists among African Americans for greater periodontal disease and incident vascular events, then what modifications can clinicians make to prevent recurrent vascular events in this population?

The PREMIERS study is a proposal for conducting an adequately powered two-center phase III randomized controlled trial to test whether intensive periodontal treatment reduces the risk of recurrent vascular events among ischemic stroke and TIA survivors. The study uses the resources in both states including established dental centers, Joint Commission Certified Stroke Centers, the Schools of Public Health, and the Institute for Partnerships to Eliminate Health Disparities. The proposal addresses specific issues with regards to recruitment of African-American and rural stroke/TIA patients advocating the use of culturally appropriate strategies to educate the study subjects regarding stroke, periodontal disease and the periodontal stroke link. The study proposes to utilize economic evaluation of the periodontal intervention from the budgetary perspective. The focus will be on the financial sustainability of providing aggressive periodontal therapy (with certain, although relatively low expenditures) in exchange for a reduction of uncertain recurrent vascular events that may require high cost emergency department utilization and/or inpatient care. The sustainability of the proposed intervention after the completion of the project is integrally linked to the health economic assessment to show the health care cost savings. By integration with a rural primary care center, with an African American majority and households with average incomes below the state average, the study ensures that the proposed intervention to reduce stroke disparity is applicable to this target population.

Objectives:

The investigators propose to conduct a phase III randomized controlled trial to test whether intensive periodontal treatment reduces the risk of recurrent vascular events among ischemic stroke and TIA survivors.

Since AAs in the United States who are 50-64 years of age have approximately three times more PD than whites in the same age group, this study will also contribute to the investigators understanding of existing racial disparities in stroke incidence in the United States.