Chewing Gum and Cognitive Function

Cognitive Dysfunction Clinical Trial

Official title:

Effect of Chewing Gum on Cognitive Function

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05873023
• Other study ID #: 202105034
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Cognitive Dysfunction

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