UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051778 |
|---|---|
| Receipt number | R000059088 |
| Scientific Title | Exploratory study on mastication training method using hard foods |
| Date of disclosure of the study information | 2023/10/01 |
| Last modified on | 2024/08/01 09:17:06 |
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Basic information
Public title
Study on mastication training method using hard foods
Acronym
Mastication training method using hard foods
Scientific Title
Exploratory study on mastication training method using hard foods
Scientific Title:Acronym
Mastication training method using hard foods
Region
| Japan |
Condition
Condition
healthy elderly people
Classification by specialty
| Dental medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the feasibility of training regarding mastication training methods using hard foods.
Basic objectives2
Others
Basic objectives -Others
The implementation rates of the mastication training program
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The implementation rates of the mastication training program
Key secondary outcomes
Impression of hard foods, self-reported oral function, bite force, masticatory function, masticatory muscle activity, ultrasound imaging of masticatory muscles
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food | Maneuver |
Interventions/Control_1
Once-daily mastication training with hard foods
Interventions/Control_2
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) Those who understand the purpose of this study and can consent to it.
(2) Those who have at least 20 teeth.
(3) Those who have a complete set of first and second molars, including prosthetic teeth.
(4) Those who had bite force of less than 375 N (assessed by Oramo-bf), masticatory function of less than 7 (assessed by gummy jelly), masticatory function of less than 4 (assessed by chewing gum).
Key exclusion criteria
(1) Those who had incomplete data
(2) Those who are at risk of dysphagia
(3) Those who had serious systemic diseases
(4) Those who are participating in other intervention studies, or will be participating in such studies within 4 weeks
(5) Those who had food allergies to hard foods ingredients, and etc.
(6) Those who are judged to be ineligible for the study by the judgment of the dentists (principal investigators or research coordinators).
(7) Those who live alone or who live with someone that is hospitalized or requires nursing care.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Hirohiko |
| Middle name | |
| Last name | Hirano |
Organization
Tokyo Metropolitan Institute for Geriatrics and Gerontology
Division name
Research Team for Promoting Independence and Mental Health
Zip code
173-0015
Address
35-2 Sakae-cho, Itabashi-ku, Tokyo
TEL
03-3964-1141
hhirano@tmig.or.jp
Public contact
Name of contact person
| 1st name | Maki |
| Middle name | |
| Last name | Shirobe |
Organization
Tokyo Metropolitan Institute for Geriatrics and Gerontology
Division name
Research Team for Promoting Independence and Mental Health
Zip code
173-0015
Address
35-2 Sakae-cho, Itabashi-ku, Tokyo
TEL
03-3964-1141
Homepage URL
mshirobe@tmig.or.jp
Sponsor or person
Institute
Tokyo Metropolitan Institute for Geriatrics and Gerontology
Institute
Department
Personal name
Funding Source
Organization
Sunstar Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Sunstar Inc.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
the ethics committee of the Tokyo Metropolitan Institute for Geriatrics and Gerontology
Address
35-2 Sakae-cho, Itabashi-ku, Tokyo
Tel
03-3964-1141
rinsyoushiken@tmghig.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
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 10 | Month | 01 | 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
20
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
No longer recruiting
Date of protocol fixation
| 2023 | Year | 07 | Month | 17 | Day |
Date of IRB
| 2023 | Year | 07 | Month | 17 | Day |
Anticipated trial start date
| 2023 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2024 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2024 | Year | 05 | Month | 30 | Day |
Date analysis concluded
| 2024 | Year | 06 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2023 | Year | 08 | Month | 01 | Day |
Last modified on
| 2024 | Year | 08 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059088
