UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029079 |
|---|---|
| Receipt number | 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 14:10:38 |
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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
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
hms-ikeda.endo@tmd.ac.jp
Sponsor or person
Institute
Operative Dentistry and Endodontics, Dental Hospital, Tokyo Medical and Dental University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033191
