Cognitive Changes and Neural Correlates After Rehabilitation of Masticatory Function in Elderly -… (NCT04458207) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Cognitive Changes and Neural Correlates After Rehabilitation of Masticatory Function in Elderly -an Intervention Study
Sweden80 participantsStarted 2018-11-02
Plain-language summary
Today in elderly tooth loss and loss of oral function is widespread, but it is an underexplored modifiable risk factor potentially contributing to the development of dementia. In this interventional study a "cause-effect" relationship between mastication and cognition in humans will be investigated.
A total of eighty (80) participants, 65-80 years of age, indicated for prosthodontic rehabilitation will be randomly assigned to either the experimental or the control group. Participants will be randomized into two different groups, measurements are going to be conducted before and after prosthetic rehabilitation. The difference between the two groups is that the control group are going to do two measurements before undergoing the rehabilitation, this to control for the test-re-test effect.
The aim with this study is to determine if the rehabilitation of chewing function will cause changes in the neurocognitive assessments of episodic memory and learning.
Who can participate
Age range
65 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 65-80 years of age at start
* Impaired chewing ability (Eichner index B2-B4, C1-C4)
* Dental rehabilitation with fixed prosthodontics, implant and/or tooth supported (overdentures included) \>10 occluding units
* Mini Mental State Examination (MMSE) score \>25
Exclusion Criteria:
* Brain trauma or stroke \<6 months
* Neurological disease (stroke, dementia, Alzheimer disease, Parkinson disease).
* Intellectual disability
* Psychological disorders
* Participants with chronic pain, depression or sleeping disorders
* Daily analgesic medication that may affect cognitive and/or executive performance of the brain
* Poor Swedish language skills, reading disabilities
* Severely reduced hearing or vision
* Prosthetic treatment with removable dentures (full or partial)
MRI exclusion criteria:
* Claustrophobia
* Difficulties in lying down in a supine position for about an hour, or any other difficulties related to the MRI head coil
* Participants with metal or medical implants in the body contraindicating MRI scan
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Brief Visuospatial Memory Test Revised (BVMT-R)
Timeframe: 1: Baseline pre-test. 2: Change pre-test/post-test1, CG 3months after baseline, EG 3months after intervention (Int). 3: Change post-test1/post-test2, CG 3months after Int, EG 1year after Int. 4: Change post-test1/post-test2, CG 1year after Int.