UMIN-CTR Clinical Trial

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
Last 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
1st 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/icdr_e/ctr_view.cgi?recptno=R000036577