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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000029079
Receipt No. R000033191
Scientific Title Linguistic and cognitive-neurobiological study of pulpal innocuous sensation
Date of disclosure of the study information 2017/10/31
Last modified on 2019/04/06

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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
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
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/ctr_e/ctr_view.cgi?recptno=R000033191

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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