Cognitive Dysfunction
Conditions
Brief summary
This study is to investigate whether the improvement or maintenance of cognitive function is superior to the control group when gum chewing is performed in elderly people with subjective cognitive decline or mild cognitive impairment.
Detailed description
The intervention group chew one unscented gum provided by the study for 12 weeks. Using KakaoTalk, the coordinator sends a chewing gum alarm. The participants are instructed to masticate a gum for 20 minutes every day, alternately for 10 minutes on the right side and 10 minutes on the left side. After chewing gum, they perform masticatory muscle stretching and tongue exercises. After they finish chewing the gum, he or she reports completion by posting an authentication photo in the KakaoTalk chat room. The research coordinator checks the certification on a weekly basis and sends a separate phone call to encourage participants who do not chew gum more than twice a week.
Interventions
OTHERChewing gum
chewing gum everyday for 12 weeks. Alternate chewing for 10 minutes on the right and 10 minutes on the left.
Sponsors
Bobath Memorial Hospital
Inha University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
60 Years to 79 Years
Healthy volunteers
Yes
Inclusion criteria
* 60 to 79 years of age * All posterior teeth are evenly occluded on both sides, and those who have lost 4 or less teeth in the posterior teeth * Those who scored 50 points or less on the periodontal disease self-checklist * Meet the diagnostic criteria for subjective cognitive decline or mild cognitive impairment * Provide written informed consent
Exclusion criteria
* Those who have difficulty in chewing due to toothache, periodontal disease, temporomandibular joint disease, severe malocclusion, shaking teeth, etc. * Those who wear dentures on the upper or lower teeth * Dementia * Major psychiatric illness such as major depressive disorders * Other neurodegenerative disease (e.g., Parkinson's disease) * Other serious or unstable medical disease such as acute or severe asthma, active gastric ulcer, severe liver disease, or severe renal disease, or any medical conditions preventing to complete the study as judged by the study physician * Severe loss of vision, hearing, or communicative disability * Significant laboratory abnormality that may result in cognitive impairment * Any conditions preventing cooperation as judged by the study physician * Coincident participation in any other intervention trial * Those who are planning dental treatment such as preservation, prosthetics, and implants during the research period
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of cognition | Change from Baseline at 12 weeks | Repeatable Battery for the Assessment of Neuropsychological Status (range 40-160). Higher scores indicate better performance. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change of activities of daily living | Change from Baseline at 12 weeks | Bayer Activities of Daily Living (range 1-10). Higher scores indicate worse performance. |
| Change of quality of life | Change from Baseline at 12 weeks | Quality of life-Alzheimer's disease (range 0-52). Higher scores indicate better performance. |
| Change of function | Change from Baseline at 12 weeks | Clinical Dementia Rating scale-Sum of Boxes (range 0-18). Higher scores indicate worse performance. |
| Change of depression | Change from Baseline at 12 weeks | Geriatric Depression Scale-15 items (range 0-15). Higher scores indicate worse mood. |
| Change of global cognition | Change from Baseline at 12 weeks | Korean Mini-Mental State Examination-2 (range, 0-30). Higher scores indicate better performance. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change of cortical thickness and brain network function | Change from Baseline at 12 weeks | brain MRI (3D-T1 weighted images and resting state functional MRI) |
Countries
South Korea
Contacts
Primary ContactSeong Hye Choi, MD, PhD
Backup ContactHae Ri Na, MD, PhD
Outcome results
None listed