UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032078 |
|---|---|
| Receipt number | R000036577 |
| Scientific Title | Brain function after tooth stimulation |
| Date of disclosure of the study information | 2018/05/01 |
| Last modified on | 2019/04/04 11:22:17 |
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Basic information
Public title
Brain function after tooth stimulation
Acronym
Brain function and tooth stimulation
Scientific Title
Brain function after tooth stimulation
Scientific Title:Acronym
Brain function and tooth stimulation
Region
| Japan |
Condition
Condition
Orofacial pain
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the state of neurotransmission by stimulation from the teeth.
Basic objectives2
Others
Basic objectives -Others
The final goal is to develop a new treatment for patients who complain of occlusion discomfort.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Using the near infrared light brain function imaging device, observe the brain activity situation in the cerebral cortex.
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
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
The human maxillary premolar tooth is stimulated with a pressure stimulator.
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
| 25 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Tokushima University Hospital Dental examination patients or faculty members of Tokushima University of Tokushima
25 years old and under 65 years old (when asking for participation in research) (regardless of gender)
More than 24 teeth will remain
Key exclusion criteria
Aware of tooth bruxism
Prosthetic device is attached to bicuspid
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | YOSHIZO |
| Middle name | |
| Last name | MATSUKA |
Organization
Tokushima University
Division name
Stomatognathic Function and Occlusal Reconstruction
Zip code
770-8504
Address
3-18-15 Kuramoto-cho, Tokushima
TEL
088-633-7350
matsuka@tokushima-u.ac.jp
Public contact
Name of contact person
| 1st name | YOSHIZO |
| Middle name | |
| Last name | MATSUKA |
Organization
Tokushima University
Division name
Stomatognathic Function and Occlusal Reconstruction
Zip code
770-8504
Address
Tokushima
TEL
088-633-7350
Homepage URL
matsuka@tokushima-u.ac.jp
Sponsor or person
Institute
Tokushima University
Institute
Department
Personal name
Funding Source
Organization
Tokushima University
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
Tokushima University Hospital
Address
2-50-1 Kuramoto-cho, Tokushima
Tel
088-631-3111
bsoumuss1@tokushima-u.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
| 2018 | Year | 05 | Month | 01 | 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
2
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 | 10 | Month | 02 | Day |
Date of IRB
| 2017 | Year | 08 | Month | 15 | Day |
Anticipated trial start date
| 2017 | Year | 10 | Month | 02 | Day |
Last follow-up date
| 2019 | 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
| 2018 | Year | 04 | Month | 03 | Day |
Last modified on
| 2019 | Year | 04 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036577
| 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 |
