PeRiodontal Treatment to Eliminate Minority InEquality and Rural Disparities in Stroke

Status unconfirmed · Phase 3

Conditions studied: Periodontal Disease, Stroke, TIA

In brief

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.

Key facts

Study ID

NCT02541032

Run by

University of South Carolina

People needed

400

Starts

2015-12-01

Expected to finish

2020-06-01

Last updated by the study team

2019-04-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patient is at least 18 years of age with no upper age limit
• Patient is able to consent, follow an outpatient protocol, and is available by telephone
• Non-severely disabling initial stroke (modified Rankin score ≤ 3) or TIA in the past 90 days
• Evaluable for periodontal examination and treatment (≥ 5 teeth) and able to sustain a dental examination
• Contain ≥ 2 interproximal sites with ≥ 4 mm of clinical attachment loss (CAL) (initial periodontitis as defined by the Centers for Disease Control (CDC) Working Group on Surveillance Systems for Periodontal Infections - see below)

You may not qualify if…

• Stroke due to intracranial hemorrhage, dissection, veno-occlusive disease, drugs, trauma, or vasculitis
• Previous neurological impairment that would make detection of a subsequent event difficult
• Co-morbid conditions that may limit survival to less than one year
• Brain CT or MRI which shows a lesion other than stroke as the cause of the syndrome
• History of medical conditions requiring antibiotic prophylaxis prior to dental exam (artificial cardiac valves, previous inflammation of the heart or valves, complex heart conditions or other heart malformations since birth, surgically constructed systemic pulmonary shunts, valvular dysfunctions, prolapse, hypertrophic cardiomyopathy, first two years of joint replacement, previous infections from artificial joint, any chronic or radiation-induced condition leading to immunosuppression or hemophilia)
• Patients on oral anticoagulant therapy with a Prothrombin Time International Normalized Ratio (PT-INR) greater than 3.5 (may be corrected and enrolled).
• Pregnancy confirmed by urine pregnancy test in women of child-bearing potential (≤ 55 years age)
• Known allergy or hypersensitivity to local anesthesia or minocycline that cannot be medically managed
• Participation in another randomized clinical trial.

Where it is running

• University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States (enrolling)
• University of South Carolina School of Medicine Department of Neurology — Columbia, South Carolina, United States (enrolling)

Full record on ClinicalTrials.gov

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