UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026316 |
|---|---|
| Receipt number | R000030225 |
| Scientific Title | Electromyographic study on relationship between food texture and jaw and tongue muscle activity |
| Date of disclosure of the study information | 2017/02/27 |
| Last modified on | 2020/08/31 09:46:03 |
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Basic information
Public title
Electromyographic study on relationship between food texture and jaw and tongue muscle activity
Acronym
Electromyographic study on relationship between food texture and jaw and tongue muscle activity
Scientific Title
Electromyographic study on relationship between food texture and jaw and tongue muscle activity
Scientific Title:Acronym
Electromyographic study on relationship between food texture and jaw and tongue muscle activity
Region
| Japan |
Condition
Condition
Adult
Classification by specialty
| Dental medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aimed to examine the influence of dry, crumbling food texture on the duration of the suprahyoid muscle activity during swallowing.
Basic objectives2
Others
Basic objectives -Others
This study aimed to examine the influence of food texture on the electromyographic activity of the jaw and tongue muscles during mastication and swallowing.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Duration of suprahyoid muscles activity during swallowing
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Three times of mastication and swallowing of lower dry, crumbling food texture
Interventions/Control_2
Three times of mastication and swallowing of higher dry, crumbling food texture
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
| 40 | years-old | > |
Gender
Male and Female
Key inclusion criteria
20 years old <=
Key exclusion criteria
20 years old >
Eating and swallowing dysphagia
Less than 28 remaining teeth
Taste disorder
Target sample size
26
Research contact person
Name of lead principal investigator
| 1st name | Soshi |
| Middle name | |
| Last name | Hanawa |
Organization
Tohoku University Graduate School of Dentistry
Division name
Advanced prosthetic dentistry
Zip code
9808575
Address
4-1, Seiryo-machi, Aoba-ku, Sendai, Miyagi, Japan
TEL
0227178369
s-hanawa@umin.ac.jp
Public contact
Name of contact person
| 1st name | Soshi |
| Middle name | |
| Last name | Hanawa |
Organization
Tohoku University Graduate School of Dentistry
Division name
Advanced prosthetic dentistry
Zip code
980-8575
Address
4-1, Seiryo-machi, Aoba-ku, Sendai, Miyagi, Japan
TEL
0227178369
Homepage URL
s-hanawa@umin.ac.jp
Sponsor or person
Institute
Tohoku University Graduate School of Dentistry
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tohoku University Graduate School of Dentistry
Address
4-1, Seiryo-machi, Aoba-ku, Sendai, Miyagi, Japan
Tel
022-717-8369
s-hanawa@umin.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
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 02 | Month | 27 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://www.jstage.jst.go.jp/article/sgf/23/2/23_96/_article/-char/ja/
Number of participants that the trial has enrolled
8
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
| 2017 | Year | 02 | Month | 13 | Day |
Date of IRB
| 2017 | Year | 10 | Month | 02 | Day |
Anticipated trial start date
| 2017 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 08 | 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
| 2017 | Year | 02 | Month | 27 | Day |
Last modified on
| 2020 | Year | 08 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030225
