TerminatedNot Applicable

Dental Carotid Cognitive Study

Stopped: The COVID-19 pandemic has disrupted the investigators ability to continue this study. Follow-up visits were missed to the COVID-19 pandemic restrictions. The investigator has elected to close enrollment and stop follow-up visits.

United States26 participantsStarted 2019-04-08

Plain-language 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 with mild to moderate cognitive impairment (MCI). Older MCI patients are prone to poor oral hygiene and dental health, which if untreated worsens inflammation-mediated brain and nervous system function, and accelerates progression to dementia. Asymptomatic carotid artery stenosis (ACAS) is often a silent disease detected in only \~10% of older adults, and may have a strong association with MCI. This study examines the effects of intensive therapy for periodontitis on cognition in high-risk older people with ACAS. Results could highlight PD as a readily modifiable risk factor for dementia.

Who can participate

Age range60 Years – 100 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Criteria: * 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…

What they're measuring

Changes in performance on Montreal Cognitive Assessment (MoCA)

Timeframe: 1 year

Trial details

NCT IDNCT03755362

SponsorUniversity of Maryland, Baltimore

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-02-21