Status:
TERMINATED
Dental Carotid Cognitive Study
Lead Sponsor:
University of Maryland, Baltimore
Collaborating Sponsors:
University of Maryland, College Park
Baltimore VA Medical Center
Conditions:
Carotid Stenosis
Mild Cognitive Impairment
Eligibility:
All Genders
60-100 years
Phase:
NA
Brief Summary
Periodontal Disease (PD) is present in 60+% of adults \>65 years and is associated with tobacco smoking, diabetes, and atherosclerosis that worsen inflammation, comorbidities common in older people wi...
Detailed Description
Periodontal Disease (PD) is present in 60+% of adults \>65 years and is associated with tobacco smoking, diabetes, and atherosclerosis that worsen inflammation, comorbidities common in older people wi...
Eligibility Criteria
Inclusion
- Age equal to or greater than 65 years.
- Body Mass Index 18-35 kg/m2
- Mild to moderate periodontitis
- Mild to moderate cognitive impairment on Montreal Cognitive Assessment (MoCA) -range greater than or equal to 17 and less than or equal to 26 (i.e., range from 17-26).
- Detectable carotid plaque and carotid artery stenosis \<70% as diagnosed by doppler ultrasound.
- Able to perform prescribed dental hygiene and travel to medical center as required to participate in the study.
Exclusion
- Inability to provide informed consent.
- Subjects with inability to perform cognitive and other research testing
- Prior stroke, depression (CESD \>16), neurologic or psychiatric disease that would affect cognitive testing, participation, and compliance to the research study.
- Subjects requiring chronic treatment with systemic corticosteroids or other systemic immunosuppressive drugs or drugs that would affect the dental treatments in the protocol are excluded.
- Subjects requiring essential dental care (e.g., treatment for grossly decayed teeth, broken teeth, dental abscesses, peri-apical infections, other dental infections).
- Inability to perform FDG-PET due to renal disease (eGFR \<30 mL/min/1.75m2).
- Receiving anticoagulant therapy (Warfarin) with an INR greater than 3.3 at time of dental treatment or with a bleeding disorder, or other diseases that may interfere with dental therapy.
- Subjects with medical conditions that the clinicians feel would limit their ability to participate.
Key Trial Info
Start Date :
April 8 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 25 2021
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT03755362
Start Date
April 8 2019
End Date
February 25 2021
Last Update
July 23 2021
Active Locations (1)
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1
University of Maryland - Administrative Center
Baltimore, Maryland, United States, 21201