Cognitive Decline Clinical Trial
Official title:
Cognitive Changes and Neural Correlates After Rehabilitation of Masticatory Function in Older Adults - an Intervention Study
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.
Status | Recruiting |
Enrollment | 80 |
Est. completion date | December 30, 2025 |
Est. primary completion date | December 30, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 65 Years to 80 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Sweden | Eastmaninstitutet Folktandvården Stockholm AB | Stockholm |
Lead Sponsor | Collaborator |
---|---|
Folktandvården Stockholms län AB | Karolinska Institutet |
Sweden,
Klineberg I, Palla S, Trulsson M. Contemporary relevance of occlusion and mastication. Int J Prosthodont. 2014 Sep-Oct;27(5):411-2. doi: 10.11607/ijp.2014.5.e. No abstract available. — View Citation
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O'Brien JT, Markus HS. Vascular risk factors and Alzheimer's disease. BMC Med. 2014 Nov 11;12:218. doi: 10.1186/s12916-014-0218-y. — View Citation
Ohkubo C, Morokuma M, Yoneyama Y, Matsuda R, Lee JS. Interactions between occlusion and human brain function activities. J Oral Rehabil. 2013 Feb;40(2):119-29. doi: 10.1111/j.1365-2842.2012.02316.x. Epub 2012 May 25. — View Citation
Ono Y, Yamamoto T, Kubo KY, Onozuka M. Occlusion and brain function: mastication as a prevention of cognitive dysfunction. J Oral Rehabil. 2010 Aug;37(8):624-40. doi: 10.1111/j.1365-2842.2010.02079.x. Epub 2010 Mar 2. — View Citation
Prince M, Bryce R, Albanese E, Wimo A, Ribeiro W, Ferri CP. The global prevalence of dementia: a systematic review and metaanalysis. Alzheimers Dement. 2013 Jan;9(1):63-75.e2. doi: 10.1016/j.jalz.2012.11.007. — View Citation
Teixeira FB, Pereira Fernandes Lde M, Noronha PA, dos Santos MA, Gomes-Leal W, Ferraz Maia Cdo S, Lima RR. Masticatory deficiency as a risk factor for cognitive dysfunction. Int J Med Sci. 2014 Jan 10;11(2):209-14. doi: 10.7150/ijms.6801. eCollection 2014. — View Citation
Weijenberg RA, Scherder EJ, Lobbezoo F. Mastication for the mind--the relationship between mastication and cognition in ageing and dementia. Neurosci Biobehav Rev. 2011 Jan;35(3):483-97. doi: 10.1016/j.neubiorev.2010.06.002. Epub 2010 Jun 12. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Brief Visuospatial Memory Test Revised (BVMT-R) | Measuring non-verbal episodic memory. Measured in correct answers. Score: 0-36. A high score indicates a better performance. | 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. | |
Secondary | Change in Rey Auditory Verbal Learning Test (RAVLT). | Measuring verbal episodic memory. Measured in correct answers. Scale: 0-90. A high score indicates a better performance. | 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. | |
Secondary | Change in Trail Making Test from Delis Kaplan Executive Function System (D-KEFS) | Measuring executive function. Measured in seconds and number of faults (maximum 150 seconds). A low score indicates a better performance. | 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. | |
Secondary | Change in Digit-Span from Wechsler Adult Intelligence Scale (WAIS):IV | Measuring working memory. Measured in correct answers. Score: 0-48. A high score indicates better performance. | 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. | |
Secondary | Change in Digit-symbol from Wechsler Adult Intelligence Scale (WAIS):IV | Measuring motor and mental speed. Measured in correct answers. Score: 0-135. A high score indicates better performance. | 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. | |
Secondary | Change in Color-Word Interference Test from Delis Kaplan Executive Function System (D-KEFS word) | Measuring executive memory. Measured in seconds to complete test (maximum 90 seconds). Higher score indicates a poorer performance. | 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. | |
Secondary | Change in verbal fluency from Delis Kaplan Executive Function System (D-KEFS-F) | Measuring executive memory. Measured in correct answer during a time limit (60 seconds). A high score indicates a better performance. | 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. | |
Secondary | Title: Changes in blood perfusion in the brain tissue by measuring cerebral blood flow (CBF) in the brain over time with magnetic resonance imaging (MRI). | Measured with MRI using the Pseudo- Continuous Arterial Spin Labeling (pCASL) technique. The unit of measurement is ml of blood per 100 gram tissue per unit of time (ml/100g/min). | 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. | |
Secondary | Changes in brain activity (BA) over time measured with magnetic resonance imaging (MRI). | Measuring changes in functional connectivity over time with MRI using the Blood Oxygen Level Dependent (BOLD) technique under resting state conditions. | 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. | |
Secondary | Change of the masseter muscle volume (MMV) with magnetic resonance imaging (MRI). | Measured with MRI using a PD-weighted SPACE sequence to determine the pre- and post-muscle volume. Volume increase indicates volume increase in muscle masseter. | 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. | |
Secondary | Change in mixing ability (MA) two-coloured chewing gum (Orophys chewing gum) | Two-coloured Orophys chewing gum. More mixed colour in the sample indicates better chewing ability. | 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. | |
Secondary | Change in measure of cortisol level (CL) in saliva | Biological measures. Low level of cortisol indicate lower stress hormone levels. | 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. | |
Secondary | Change in Oral Health Impact Profile, short version (OHIP-14). | Questionnaire measuring impact on daily life coast by oral problems. Scale: 0-56. Higher score indicates more impact or oral problems. | 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. | |
Secondary | Change in psychological wellbeing the day of psychological assessment by using Hospital Anxiety and Depression scale (HAD). | Questionnaire measuring Depression and Anxiety. Scale: 0-42. A low score indicate a more positive outcome. | 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. |
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