Chewing Gum and Cognitive Function

Not Applicable

Recruiting

• Conditions: Cognitive Dysfunction
• Interventions: Other: Chewing gum

• Registration Number: NCT05873023
• Lead Sponsor: Inha University Hospital

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.

Study Timeline

• Study Start: 2022-10-17
• Status Verified: 2023-05
• Study First Submitted: 2023-05-15
• Study First Submitted QC: 2023-05-15
• Last Update Submitted: 2023-05-15
• Study First Posted: 2023-05-24
• Last Update Posted: 2023-05-24
• Primary Completion: 2023-12-15
• Study Completion: 2023-12-29

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 94

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Chewing gum	The intervention group chew one unscented gum provided by the study for 12 weeks. 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 a proof photo in the KakaoTalk chat room.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 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 global cognition	Change from Baseline at 12 weeks	Korean Mini-Mental State Examination-2 (range, 0-30). Higher scores indicate better 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 quality of life	Change from Baseline at 12 weeks	Quality of life-Alzheimer's disease (range 0-52). Higher scores indicate better performance.

Trial Locations

Locations (4)

Bobath Memorial Hospital; 🇰🇷 Seongnam, Gyeonggi-do, Korea, Republic of

Ewha Womans Seoul Hospital; 🇰🇷 Seoul, Korea, Republic of

Inha University Hospital; 🇰🇷 Incheon, Korea, Republic of

Ajou University Hospital; 🇰🇷 Suwon, Korea, Republic of