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PeRiodontal Treatment to Eliminate Minority InEquality and Rural Disparities in Stroke (PREMIERS)

This study is currently recruiting participants.
Verified May 2017 by University of South Carolina
Sponsor:
ClinicalTrials.gov Identifier:
NCT02541032
First Posted: September 4, 2015
Last Update Posted: May 31, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
University of North Carolina, Chapel Hill
Information provided by (Responsible Party):
University of South Carolina
  Purpose

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 Intervention Phase
Periodontal Disease Stroke TIA Procedure: Intensive dental treatment Procedure: Standard dental treatment Drug: Arestin Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: PeRiodontal Treatment to Eliminate Minority InEquality and Rural Disparities in Stroke

Resource links provided by NLM:


Further study details as provided by University of South Carolina:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 400
Study Start Date: December 2015
Estimated Study Completion Date: June 2020
Estimated Primary Completion Date: June 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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:
  • Scaling
  • Planing
  • Hand Scaler
  • Ultrasonic Scaler
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.
Other Names:
  • Scaling
  • Polishing
  • Hand Scaler

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02541032


Contacts
Contact: Daniel L Christmus 803-777-4452 danielc@mailbox.sc.edu
Contact: Kolby T Redd, PhD 803-545-6078 Kolby.Redd@uscmed.sc.edu

Locations
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   
Sponsors and Collaborators
University of South Carolina
University of North Carolina, Chapel Hill
Investigators
Principal Investigator: Souvik Sen, MD University of South Carolina
  More Information

Responsible Party: University of South Carolina
ClinicalTrials.gov Identifier: NCT02541032     History of Changes
Other Study ID Numbers: 00044329
First Submitted: July 6, 2015
First Posted: September 4, 2015
Last Update Posted: May 31, 2017
Last Verified: May 2017

Additional relevant MeSH terms:
Stroke
Periodontal Diseases
Gingival Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Mouth Diseases
Stomatognathic Diseases
Minocycline
Anti-Bacterial Agents
Anti-Infective Agents