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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05873023
Other study ID # 202105034
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 17, 2022
Est. completion date December 29, 2023

Study information

Verified date May 2023
Source Inha University Hospital
Contact Seong Hye Choi, MD, PhD
Phone 82 32 8902947
Email seonghye@inha.ac.kr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 94
Est. completion date December 29, 2023
Est. primary completion date December 15, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 60 Years to 79 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Chewing gum
chewing gum everyday for 12 weeks. Alternate chewing for 10 minutes on the right and 10 minutes on the left.

Locations

Country Name City State
Korea, Republic of Inha University Hospital Incheon
Korea, Republic of Bobath Memorial Hospital Seongnam Gyeonggi-do
Korea, Republic of Ewha Womans Seoul Hospital Seoul
Korea, Republic of Ajou University Hospital Suwon

Sponsors (2)

Lead Sponsor Collaborator
Inha University Hospital Bobath Memorial Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Other Change of cortical thickness and brain network function brain MRI (3D-T1 weighted images and resting state functional MRI) Change from Baseline at 12 weeks
Primary Change of cognition Repeatable Battery for the Assessment of Neuropsychological Status (range 40-160). Higher scores indicate better performance. Change from Baseline at 12 weeks
Secondary Change of global cognition Korean Mini-Mental State Examination-2 (range, 0-30). Higher scores indicate better performance. Change from Baseline at 12 weeks
Secondary Change of function Clinical Dementia Rating scale-Sum of Boxes (range 0-18). Higher scores indicate worse performance. Change from Baseline at 12 weeks
Secondary Change of depression Geriatric Depression Scale-15 items (range 0-15). Higher scores indicate worse mood. Change from Baseline at 12 weeks
Secondary Change of activities of daily living Bayer Activities of Daily Living (range 1-10). Higher scores indicate worse performance. Change from Baseline at 12 weeks
Secondary Change of quality of life Quality of life-Alzheimer's disease (range 0-52). Higher scores indicate better performance. Change from Baseline at 12 weeks
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