UMIN-CTR Clinical Trial

Public title

Effects of training gum chewing on oral function

Acronym

Effects of training gum chewing on oral function

Scientific Title

Effects of training gum chewing on oral function

Scientific Title:Acronym

Effects of training gum chewing on oral function

Region

Japan

Condition

oral hypofunction

Classification by specialty

Dental medicine

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

The purpose of the study was to perform a one-month gum or tablet intake intervention for men and women between the ages of 65 and 85, and change in height and weight, oral examination results, and oral function detailed examination results (bite force, dry mouth, To investigate the effect of training gum chewing on oral function based on tongue pressure, tongue and lip motor function), changes in masticatory behavior (test gum intake time), and subjective evaluation.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Oral function detailed examination
1. Bite force quotient: Pressure sensitive sheet (Dental Prescale II /GC Corporation)
2. Xerostomia
Spitting method
Oral moisture: oral moisture meter (oral moisture meter Mucus /YOSHIDA Co., Ltd.)
3.Tongue pressure: Tongue pressure measuring device (JMS tongue pressure measuring device / JMS Co., Ltd.)
4. Tongue and lip movement function: automatic measuring instrument (Kenguchi Handy-kun / Company Takei Kikai Kogyo)
5. Evaluation of masticatory ability
chewing ability judgment color change gum (chewing check gum / Lotte Co., Ltd.)
6. Chewing behavior
Test gum intake time
Self-administered questionnaire

Key secondary outcomes

height, weight

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Cluster

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

YES

Dynamic allocation

Institution consideration

Blocking

YES

Concealment

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Food	Behavior,custom

Interventions/Control_1

Intervention period: 1 month
Study subjects chew and ingest 2 test gums / dose, 3 sets daily, at home

Various measurements are taken once before and after the intervention, and data is collected.

Interventions/Control_2

Intervention period: 1 month
The subjects of the study chew 3 tablets / time and 3 sets a day at home.

Various measurements are taken once before and after the intervention, and data is collected.

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

65

years-old

<=

Age-upper limit

85

years-old

>

Gender

Male and Female

Key inclusion criteria

1) Those who have difficulty eating hard foods compared to half a year ago
2) Those who are independent in activities of daily living such as excretion, bathing, walking, eating, and conditioning
3) Persons with no history of systemic diseases such as cerebral infarction and orthopedic diseases
4) Those who have no problem with cognitive function
5) Those who are not currently receiving dental treatment
6) Those who have 20 or more remaining teeth
7) Those who can eat chewing gum and tablets
8) Those who do not have gelatin allergies

Key exclusion criteria

1) Exclude 1 test gum x 2 times less than 5 minutes in ascending order.
2) Exclude one test gum x 2 times for less than 5 minutes, and then exclude those with extremely long or short intake time.
3) The maximum number of excluded persons is 36.

Target sample size

120

Name of lead principal investigator

1st name	MANABU
Middle name
Last name	KANAZAWA

Organization

Graduate School of Medical and Dental Sciences

Division name

Gerodontology and Oral Rehabilitation

Zip code

113-8549

Address

1-5-45 Yushima Bunkyo-ku Tokyo

TEL

0358034645

Email

m.kanazawa.gerd@tmd.ac.jp

Name of contact person

1st name	HARUKO
Middle name
Last name	KATADA

Organization

Graduate School of Medical and Dental Sciences

Division name

Gerodontology and Oral Rehabilitation

Zip code

113-8549

Address

1-5-45 Yushima Bunkyo-ku Tokyo

TEL

03358035585

Homepage URL

Email

h.katada.gerd@tmd.ac.jp

Institute

TOKYO MEDICAL AND DENTAL UNIVERSITY

Institute

Department

Personal name

Organization

LOTTE CO., LTD.

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

TOKYO MEDICAL AND DENTAL UNIVERSITY

Address

1-5-45 Yushima Bunkyo-ku Tokyo

Tel

0358035585

Email

m.kanazawa.gerd@tmd.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

東京医科歯科大学（東京都）

Date of disclosure of the study information

2020

Year

11

Month

16

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Preinitiation

Date of protocol fixation

2020

Year

10

Month

01

Day

Date of IRB

Anticipated trial start date

2021

Year

04

Month

01

Day

Last follow-up date

2022

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2020

Year

11

Month

16

Day

Last modified on

2020

Year

11

Month

16

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048128