PeRiodontal Treatment to Eliminate Minority InEquality and Rural Disparities in Stroke

• Status: Unknown status
• Trial end date: 2020-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of South Carolina
• Collaborator: University of North Carolina, Chapel Hill
• Treatments: Minocycline

Criteria

Inclusion Criteria:

1. Patient is at least 18 years of age with no upper age limit

2. Patient is able to consent, follow an outpatient protocol, and is available by telephone

3. Non-severely disabling initial stroke (modified Rankin score ≤ 3) or TIA in the past 90 days

4. Evaluable for periodontal examination and treatment (≥ 5 teeth) and able to sustain a dental examination

5. 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)

Exclusion Criteria:

1. Stroke due to intracranial hemorrhage, dissection, veno-occlusive disease, drugs, trauma, or vasculitis

2. Previous neurological impairment that would make detection of a subsequent event difficult

3. Co-morbid conditions that may limit survival to less than one year

4. Brain CT or MRI which shows a lesion other than stroke as the cause of the syndrome

5. 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)

6. Patients on oral anticoagulant therapy with a Prothrombin Time International Normalized Ratio (PT-INR) greater than 3.5 (may be corrected and enrolled).

7. Pregnancy confirmed by urine pregnancy test in women of child-bearing potential (≤ 55 years age)

8. Known allergy or hypersensitivity to local anesthesia or minocycline that cannot be medically managed

9. Participation in another randomized clinical trial.