Chewing Gum and Cognitive Function

NCT ID: NCT05873023

Last Updated: 2023-05-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

94 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-17

Study Completion Date

2023-12-29

Brief Summary

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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

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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.

Conditions

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Cognitive Dysfunction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Intervention

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.

Group Type EXPERIMENTAL

Chewing gum

Intervention Type OTHER

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

Control

The control group does not participate in chewing gum.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Chewing gum

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

60 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Bobath Memorial Hospital

OTHER

Sponsor Role collaborator

Inha University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hae Ri Na, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Bobath Memorial Hospital

Locations

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Bobath Memorial Hospital

Seongnam-si, Gyeonggi-do, South Korea

Site Status RECRUITING

Inha University Hospital

Incheon, , South Korea

Site Status RECRUITING

Ewha Womans Seoul Hospital

Seoul, , South Korea

Site Status RECRUITING

Ajou University Hospital

Suwon, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Seong Hye Choi, MD, PhD

Role: CONTACT

82 32 8902947

Hae Ri Na, MD, PhD

Role: CONTACT

Facility Contacts

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Hae Ri Na, MD, PhD

Role: primary

Seong Hye Choi, MD

Role: primary

Jee Hyang Jeong, MD, PhD

Role: primary

So Young Moon, MD, PhD

Role: primary

Other Identifiers

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202105034

Identifier Type: -

Identifier Source: org_study_id

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