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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000032078
Receipt No. R000036577
Scientific Title Brain function after tooth stimulation
Date of disclosure of the study information 2018/05/01
Last modified on 2019/04/04

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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
Email 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
Email matsuka@tokushima-u.ac.jp

Sponsor
Institute Tokushima University
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036577

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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