UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049012 |
|---|---|
| Receipt number | R000055810 |
| Scientific Title | Effects of food physical properties and aging on chewing and swallowing functions |
| Date of disclosure of the study information | 2022/09/30 |
| Last modified on | 2022/09/21 17:28:40 |
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Basic information
Public title
Effects of food physical properties and aging on chewing and swallowing functions
Acronym
Effects of food physical properties and aging on chewing and swallowing functions
Scientific Title
Effects of food physical properties and aging on chewing and swallowing functions
Scientific Title:Acronym
Effects of food physical properties and aging on chewing and swallowing functions
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Dental medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Clarify the effects of food physical properties and aging on chewing and swallowing functions
Basic objectives2
Others
Basic objectives -Others
Derivation of muscle activity using electromyography
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Derivation of muscle activity
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 18 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male
Key inclusion criteria
(1)Male
(2)Normal toothed jaw (no missing teeth and functional abnormalities in the oral and maxillofacial system)
(3)Age 18-34 years or 70-80 years (at the time of enrollment)
(4)Persons who have given their written consent to participate in the study
Key exclusion criteria
(1)Female
(2)Under 18 years old, 35-69 years old, over 81 years old
(3)Those with oral hypofunction
(4)Those with dysphagia
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Toru |
| Middle name | |
| Last name | Ogawa |
Organization
Tohoku University
Division name
Graduate School of Dentistry Division of Advanced Prosthetic Dentistry
Zip code
980-8575
Address
4-1 Seiryo-machi, Aoba-ku, Sendai, 980-8575 Miyagi
TEL
022-717-8369
toru.ogawa.d7@tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Toru |
| Middle name | |
| Last name | Ogawa |
Organization
Tohoku University
Division name
Graduate School of Dentistry Division of Advanced Prosthetic Dentistry
Zip code
980-8575
Address
4-1 Seiryo-machi, Aoba-ku, Sendai, 980-8575 Miyagi
TEL
022-717-8369
Homepage URL
toru.ogawa.d7@tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
None
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
Ethics Committee of Tohoku University Graduate School of Dentistry
Address
4-1 Seiryo-machi, Aoba-ku, Sendai, 980-8575 Miyagi
Tel
022-728-4205
Ec-den@rinri.hosp.tohoku.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
| 2022 | Year | 09 | Month | 30 | 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
| 2022 | Year | 09 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2022 | Year | 09 | Month | 30 | 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
Although there have been many studies on food mass formation by mastication, there have been few studies on the relationship between the physical properties of the food mass immediately before swallowing and further electromyographic evaluation. Since the physical properties of a food mass just before swallowing may have a significant impact on the ease of swallowing, it is important to clarify the relationship between the physical properties of a food mass and the aspects of muscle activity of the muscles related to mastication and swallowing.
Management information
Registered date
| 2022 | Year | 09 | Month | 26 | Day |
Last modified on
| 2022 | Year | 09 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055810
