UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041623 |
|---|---|
| Receipt number | R000047511 |
| Scientific Title | Effect of chewing well on mastication and swallowing |
| Date of disclosure of the study information | 2020/08/31 |
| Last modified on | 2025/03/05 13:08:25 |
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Basic information
Public title
Effect of chewing well on mastication and swallowing
Acronym
Effect of chewing well on mastication and swallowing
Scientific Title
Effect of chewing well on mastication and swallowing
Scientific Title:Acronym
Effect of chewing well on mastication and swallowing
Region
| Japan |
Condition
Condition
healthy subjects
Classification by specialty
| Rehabilitation medicine | Dental medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study was to investigate the effect of chewing well on mastication and swallowing in healthy subjects.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
masticatory and swallowing related muscles activity
moving x-ray examination of swallowing
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
chewing well
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
| 20 | years-old | <= |
Age-upper limit
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy subjects who have no symptoms associated with dysphagia
Key exclusion criteria
Subjects with coughing, swallowing and speech problems, Subjects had histories of respiratory or neurological disease
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Takanori |
| Middle name | |
| Last name | Tsujimura |
Organization
Niigata University Graduate School of Medical and Dental Sciences
Division name
Division of Dysphagia Rehabilitation
Zip code
9518514
Address
2-5274 Gakkocho-dori, Chuo-ku, Niigata city
TEL
0252272999
tsujimura@dent.niigata-u.ac.jp
Public contact
Name of contact person
| 1st name | Takanori |
| Middle name | |
| Last name | Tsujimura |
Organization
Niigata University Graduate School of Medical and Dental Sciences
Division name
Division of Dysphagia Rehabilitation
Zip code
9518514
Address
2-5274 Gakkocho-dori, Chuo-ku, Niigata city
TEL
0252272999
Homepage URL
tsujimura@dent.niigata-u.ac.jp
Sponsor or person
Institute
Niigata University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee of Niigata University
Address
757 Ichiban-cho Asahimachi-dori Chu-o-ku, Niitata city
Tel
025-227-2625
ethics@adm.niigata-u.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
2020-0173
Org. issuing International ID_1
2020-0173
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 08 | Month | 31 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
35
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
Completed
Date of protocol fixation
| 2020 | Year | 08 | Month | 26 | Day |
Date of IRB
| 2020 | Year | 08 | Month | 26 | Day |
Anticipated trial start date
| 2020 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2025 | 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 | 08 | Month | 31 | Day |
Last modified on
| 2025 | Year | 03 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047511
