UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042846 |
|---|---|
| Receipt number | R000048909 |
| Scientific Title | Study for gustatory evoked magnetic fields |
| Date of disclosure of the study information | 2020/12/25 |
| Last modified on | 2023/06/28 11:18:01 |
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Basic information
Public title
Study for gustatory evoked magnetic fields
Acronym
Study for gustatory evoked magnetic fields
Scientific Title
Study for gustatory evoked magnetic fields
Scientific Title:Acronym
Study for gustatory evoked magnetic fields
Region
| Japan |
Condition
Condition
Adults
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to detect the gustatory evoked fields to stimulate various gustatory substances
Basic objectives2
Others
Basic objectives -Others
To examine whether SEFs can be objective parameter for dysgeusia
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The location of gustatory evoked fields
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
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Gustatory substances are applied.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Men and Women over 20 years of age at the time of obtaining informed consent
2.Subjects who agreed with the document to participate in this research
3.Subjects who do not have communication disorder
Key exclusion criteria
1.Subjects who have Dysgeusia
2.Subjects who have oral mucosal disease
3.Subjects with severe vomiting reflex
4.Subjects with a history of aspiration pneumonia
5.Subjects who have judged disqualification by MRI/MEG inspection check sheet
6.Subjects who have judged that it is difficult to participate in this study
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Hiroki |
| Middle name | |
| Last name | Hihara |
Organization
Tohoku University Graduate School of Dentisitry
Division name
Advanced Prosthetic Dentistry
Zip code
980-8575
Address
4-1 Seiryo-machi, Aoba-ku,Sendai,980-8575,Japan
TEL
022-717-8369
hihara@dent.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Hiroki |
| Middle name | |
| Last name | Hihara |
Organization
Tohoku University Graduate School of Dentistry
Division name
Advanced Prosthetic Dentistry
Zip code
980-8575
Address
4-1 Seiryo-machi, Aoba-ku,Sendai,980-8575,Japan
TEL
022-717-8369
Homepage URL
hihara@dent.tohoku.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
Ethical committee of the Tohoku University Graduate School of Dentistry
Address
4-1 Seiryo-machi, Aoba-ku,Sendai,980-8575,Japan
Tel
022-717-8244
den-syom@grp.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
| 2020 | Year | 12 | Month | 25 | 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
Enrolling by invitation
Date of protocol fixation
| 2020 | Year | 12 | Month | 25 | Day |
Date of IRB
| 2020 | Year | 12 | Month | 25 | Day |
Anticipated trial start date
| 2021 | Year | 01 | Month | 13 | Day |
Last follow-up date
| 2025 | Year | 07 | 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 | 12 | Month | 25 | Day |
Last modified on
| 2023 | Year | 06 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048909
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
