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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000042846
Receipt No. R000048909
Scientific Title Study for gustatory evoked magnetic fields
Date of disclosure of the study information 2020/12/25
Last modified on 2021/07/01

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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
Email 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
Email hihara@dent.tohoku.ac.jp

Sponsor
Institute Tohoku University Graduate School of Dentistry
Institute
Department

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
Email 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 Open public recruiting
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
2021 Year 07 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048909

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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