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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000042470
Receipt No. R000048128
Scientific Title Effects of training gum chewing on oral function
Date of disclosure of the study information 2020/11/16
Last modified on 2020/11/16

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Basic information
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
Condition oral hypofunction
Classification by specialty
Dental medicine
Classification by malignancy Others
Genomic information NO

Objectives
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

Assessment
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

Base
Study type Interventional

Study design
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

Intervention
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

Eligibility
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

Research contact person
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

Public contact
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

Sponsor
Institute TOKYO MEDICAL AND DENTAL UNIVERSITY
Institute
Department

Funding Source
Organization LOTTE CO., LTD.
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
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
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 東京医科歯科大学(東京都)

Other administrative information
Date of disclosure of the study information
2020 Year 11 Month 16 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
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

Progress
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
Other related information

Management information
Registered date
2020 Year 11 Month 16 Day
Last modified on
2020 Year 11 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048128

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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