Recruiting
Phase 3

Periodontal Treatment

Sponsor:

University of South Carolina

Code:

NCT02541032

Conditions

Periodontal Disease

Stroke

TIA

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Intensive dental treatment

Standard dental treatment

Arestin

Study Details

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.

Conditions

Periodontal Disease

Stroke

TIA

Study ID

NCT02541032

Start date

Dec, 2015

Status verified date

Apr, 2019

Completion date

Jun, 2020

Anticipated

Primary completion date

Jun, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

400 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

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.

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.

Interventions

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.

Standard dental treatment

Supragingival mechanical scaling and polishing.

Arestin

To better suppress the oral biofilm by administering Arestin locally into the periodontal pockets ≥6 mm.

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Daniel L Christmus

803-777-4452danielc@mailbox.sc.edu

Kolby T Redd, PhD

803-545-6078Kolby.Redd@uscmed.sc.edu

Locations

University of North Carolina at Chapel Hill

Recruiting

Chapel Hill, North Carolina, United States, 27599

Contacts

Sherrill T Phillips, RDH-BS

919-537-3422Sherrill_Phillips@unc.edu

University of South Carolina School of Medicine Department of Neurology

Recruiting

Columbia, South Carolina, United States, 29203

Contacts

Kolby T Redd, PhD

803-545-6078Kolby.Redd@uscmed.sc.edu

More Information

Sponsor

University of South Carolina

Last update posted

Apr 18, 2019

Last verified

Apr, 2019

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-09. This information was provided to ClinicalTrials.gov by University of South Carolina on 2019-04-18. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.