PeRiodontal Treatment to Eliminate Minority InEquality and Rural Disparities in Stroke
PREMIERS
1 other identifier
interventional
400
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Dec 2015
Typical duration for phase_3
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 6, 2015
CompletedFirst Posted
Study publicly available on registry
September 4, 2015
CompletedStudy Start
First participant enrolled
December 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2020
CompletedApril 18, 2019
April 1, 2019
3.5 years
July 6, 2015
April 16, 2019
Conditions
Outcome Measures
Primary Outcomes (4)
Ischemic Stroke
One year
Transient ischemic attack (TIA)
One Year
Myocardial infarction (MI)
One Year
Cardiovascular Death
One Year
Secondary Outcomes (6)
Progression of Atherosclerosis
One Year
Vascular Cognitive Impairment
One Year
Blood Pressure
One Year
hs-CRP
One Year
hemoglobin A1c
One Year
- +1 more secondary outcomes
Study Arms (2)
Intensive Dental Treatment
ACTIVE COMPARATORPatients will undergo up to five sessions of full-mouth removal of subgingival dental plaque by the use of scaling and root planning under local anesthesia. Any hopeless teeth will be extracted during this treatment period, which will be as short as possible, but will extend to no more than 4 weeks. In addition to standard scaling and root planning, the investigators seek to better suppress the oral biofilm by administering Arestin locally into the periodontal pockets ≥6 mm. All patients will be reexamined at 3, 6 and 9 months for safety checks. Patients will be given instructions in basic oral hygiene and treated for stroke risk factors in accordance to the current guidelines for secondary stroke prevention.
Standard Dental Treatment
ACTIVE COMPARATORPatients will undergo supragingival mechanical scaling and polishing. They will be informed of the presence and severity of their periodontal disease and will be advised to be seen by their dentist if their condition requires immediate attention. If they have no dental provider they will be referred for care. All patients will be reexamined at 3, 6 and 9 months for safety checks. Among the group the periodontal condition will be monitored to assure there is no progression of disease. If any site demonstrates an increase in periodontal pockets \>3mm, they will receive site-directed scaling and root planing. Patients will be given instructions in basic oral hygiene and treated for stroke risk factors in accordance to the current guidelines for secondary stroke prevention. At the completion of the study, the control treatment patients will be offered to receive the same dental care as provided to the intensive treatment group as needed.
Interventions
Up to five sessions of full-mouth removal of subgingival dental plaque by the use of scaling and root planning under local anesthesia. Any hopeless teeth will be extracted during this treatment period, which will be as short as possible, but will extend to no more than 4 weeks. In addition to standard scaling and root planning, the investigators seek to better suppress the oral biofilm by administering Arestin locally into the periodontal pockets ≥6 mm.
Supragingival mechanical scaling and polishing.
To better suppress the oral biofilm by administering Arestin locally into the periodontal pockets ≥6 mm.
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599, United States
University of South Carolina School of Medicine Department of Neurology
Columbia, South Carolina, 29203, United States
Related Publications (1)
Pikel K, Logue L, Verkuilen H, Wood S, Fritts A, Mintzer J, Bonilha L, Sethi P, Beckwith A, Huang D, Sen S. Determinants of post-stroke cognitive impairment in patients with periodontal disease. J Stroke Cerebrovasc Dis. 2025 Jul;34(7):108327. doi: 10.1016/j.jstrokecerebrovasdis.2025.108327. Epub 2025 Apr 22.
PMID: 40273963DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Souvik Sen, MD
University of South Carolina
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor and Chair, Department of Neurology
Study Record Dates
First Submitted
July 6, 2015
First Posted
September 4, 2015
Study Start
December 1, 2015
Primary Completion
June 1, 2019
Study Completion
June 1, 2020
Last Updated
April 18, 2019
Record last verified: 2019-04