Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:01 PM
Ignite Modification Date:
2025-12-24 @ 5:01 PM
NCT ID:
NCT04390750
Eligibility Criteria:
Inclusion Criteria:
* a diagnosis of mild dementia
* have at least 4 natural teeth
* 60 years and older
* living with an informal caregiver (i.e. care partner) who is age 18 or older and is willing to participate in the intervention
* community-dwelling and physically able to brush own teeth
* We will use the following guidelines to identify those with mild dementia: a) a diagnosis of dementia by a physician with dementia expertise within the past year, b) from medical records, a recent Montreal Cognitive Assessment (MoCA) score \> 14 or a Mini-Mental Status Examination (MMSE) score \> 16, and c) can follow 2 to 3-step commands
Exclusion Criteria:
* unable to have an oral health evaluation
* prescribed antibiotics prior to a regular dental visit
* has sensory or physical problems that prevent participation in the intervention
* has a terminal illness or behavioral or psychiatric disorder that would interfere with participation in the intervention
* has a medical condition such as serious congenital heart conditions, previous infective endocarditis, prosthetic cardiac valves, and cardiac transplantation with cardiac valvulopathy that places him/her at greater risk of infection from the manipulation of the gums to measure the gingival index
* has a medical condition that suppresses the immune system
* has had a total joint replacement and has had an infection in the replaced joint
* is at increased risk of bleeding due to bleeding disorder such as hemophilia or the use of anti-platelet therapy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
60 Years
Study:
NCT04390750
Study Brief:
Protocol Section:
NCT04390750