PeRiodontal Treatment to Eliminate Minority InEquality and Rural Disparities in Stroke (PREMIERS)
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|ClinicalTrials.gov Identifier: NCT02541032|
Recruitment Status : Recruiting
First Posted : September 4, 2015
Last Update Posted : May 31, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Periodontal Disease Stroke TIA||Procedure: Intensive dental treatment Procedure: Standard dental treatment Drug: Arestin||Phase 3|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||400 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Investigator, Outcomes Assessor)|
|Official Title:||PeRiodontal Treatment to Eliminate Minority InEquality and Rural Disparities in Stroke|
|Study Start Date :||December 2015|
|Estimated Primary Completion Date :||June 2019|
|Estimated Study Completion Date :||June 2020|
Active Comparator: Intensive Dental Treatment
Patients 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.
Procedure: Intensive dental treatment
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.
Other Names:Drug: Arestin
To better suppress the oral biofilm by administering Arestin locally into the periodontal pockets ≥6 mm.
Other Name: Minocycline Hydrochloride
Active Comparator: Standard Dental Treatment
Patients 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.
Procedure: Standard dental treatment
Supragingival mechanical scaling and polishing.
- Ischemic Stroke [ Time Frame: One year ]
- Transient ischemic attack (TIA) [ Time Frame: One Year ]
- Myocardial infarction (MI) [ Time Frame: One Year ]
- Cardiovascular Death [ Time Frame: One Year ]
- Progression of Atherosclerosis [ Time Frame: One Year ]Carotid IMT will be measured and analyzed on the mean IMT of the far wall for 1cm lengths of right and left carotid bifurcation and internal and common carotid arteries.
- Vascular Cognitive Impairment [ Time Frame: One Year ]White matter disease will be assessed using MRI and the Montreal Cognitive Assessment (MOCA) will be administered to assess eight domains of cognitive function: attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation.
- Blood Pressure [ Time Frame: One Year ]Blood pressure
- hs-CRP [ Time Frame: One Year ]
- hemoglobin A1c [ Time Frame: One Year ]
- Fasting Lipids [ Time Frame: One Year ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02541032
|Contact: Daniel L Christmusfirstname.lastname@example.org|
|Contact: Kolby T Redd, PhD||803-545-6078||Kolby.Redd@uscmed.sc.edu|
|United States, North Carolina|
|University of North Carolina at Chapel Hill||Recruiting|
|Chapel Hill, North Carolina, United States, 27599|
|Contact: Sherrill T Phillips, RDH-BS 919-537-3422 Sherrill_Phillips@unc.edu|
|United States, South Carolina|
|University of South Carolina School of Medicine Department of Neurology||Recruiting|
|Columbia, South Carolina, United States, 29203|
|Contact: Kolby T Redd, PhD 803-545-6078 Kolby.Redd@uscmed.sc.edu|
|Principal Investigator:||Souvik Sen, MD||University of South Carolina|