UMIN-CTR Clinical Trial

Basic information
Public title	Linguistic and cognitive-neurobiological study of pulpal innocuous sensation
Acronym	Study of pulpal innocuous sensation
Scientific Title	Linguistic and cognitive-neurobiological study of pulpal innocuous sensation
Scientific Title:Acronym	Study of pulpal innocuous sensation
Region	Japan

Condition
Condition	none (healty adult)
Classification by specialty	Dental medicine Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To clarify the existence of human innocuous cold sensation in the dental pulp
Basic objectives2	Others
Basic objectives -Others	To clarify the existence of innocuous sensation in the dental pulp
Trial characteristics_1	Others
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	This study is not clinical treatment. We apply innocuous cold stimulation onto the anterior teeth. We examine pulpal sensationlinguistically and cognitive-neurobiologically.
Key secondary outcomes	(1)After applying temperature-controlled cold water onto enamel surface of intact anterior teeth through each mouth piece, we examine what kind of sensation individual subject perceives. (2)Using fMRA, we cognitive-neurobiologically analyze the activated areas in the brain.

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 considered as a block.
Blocking	YES
Concealment	No need to know

Intervention
No. of arms	1
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Other
Interventions/Control_1	to monitor dynamic properties in the brain blood flow using fMRI
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	22 years-old <=
Age-upper limit	30 years-old >=
Gender	Male and Female
Key inclusion criteria	Each individual has upper/lower anterior teeth without restorative materials, caries and periodontal disease
Key exclusion criteria	Individual having upper/lower anterior teeth with restorative materials, caries and periodontal disease
Target sample size	15

Research contact person
Last name of lead principal investigator	1st name Middle name Last name Hideharu Ikeda
Organization	Dental Hospital, Tokyo Mediacal and Dental University
Division name	Operative Dentistry and Endodontics
Zip code
Address	1-chome, 5-45, Yuhima, Bunkyo-ku, Tokyo
TEL	03-5803-5493
Email	hms-ikeda.endo@tmd.ac.jp

Public contact
1st name of contact person	1st name Middle name Last name Hideharu Ikeda
Organization	Dental Hospital, Tokyo Mediacal and Dental University
Division name	Operative Dentistry and Endodontics
Zip code
Address	1-chome, 5-45, Yuhima, Bunkyo-ku, Tokyo
TEL	03-5803-5493
Homepage URL
Email	hms-ikeda.endo@tmd.ac.jp

Sponsor
Institute	Operative Dentistry and Endodontics, Dental Hospital, Tokyo Medical and Dental University
Institute
Department

Funding Source
Organization	Grans-in-Aid for Scientific Reearch (Japan society for the promotion of science)
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)	an individual subscription

IRB Contact (For public release)
Organization
Address
Tel
Email

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	東京医科歯科大学大学院医歯学総合研究科（東京都）

Other administrative information
Date of disclosure of the study information	2017 Year 10 Month 31 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	Preinitiation
Date of protocol fixation	2017 Year 08 Month 31 Day
Date of IRB
Anticipated trial start date	2017 Year 10 Month 01 Day
Last follow-up date	2021 Year 03 Month 31 Day
Date of closure to data entry	2021 Year 03 Month 31 Day
Date trial data considered complete	2021 Year 04 Month 30 Day
Date analysis concluded	2021 Year 04 Month 30 Day

Other
Other related information

Management information
Registered date	2017 Year 09 Month 11 Day
Last modified on	2019 Year 04 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000033191