UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029082 |
|---|---|
| Receipt number | R000033225 |
| Scientific Title | An attempt to develope a new pulp vitality test using Transmitted-light Plethysmography(TLP) |
| Date of disclosure of the study information | 2017/10/31 |
| Last modified on | 2019/08/09 20:10:26 |
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Basic information
Public title
An attempt to develope a new pulp vitality test using Transmitted-light Plethysmography(TLP)
Acronym
A new pulp vitality test using TLP
Scientific Title
An attempt to develope a new pulp vitality test using Transmitted-light Plethysmography(TLP)
Scientific Title:Acronym
A new pulp vitality test using TLP
Region
| Japan |
Condition
Condition
none (healthy adult)
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To develop a new pulp vitality test using Transmitted-light Plethysmography(TLP)
Basic objectives2
Others
Basic objectives -Others
To record TLP signals in normal period, after exercise, and after cold/pressure application to teeth, for the purpose of developing a new pulp vitality test
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
A new pulp vitality test will confirm the objective human pulp vitality after traumatic injury, in chronic inflammatory condition, and in
aged patients.
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 considered as a block.
Blocking
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
going up the stairs to 2-3 floors up
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
| 20 | years-old | <= |
Age-upper limit
| 32 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
having intact anterior teeth and premolars with no restoration, caries and periodontal disease
Key exclusion criteria
anterior teeth and premolars have restoration, caries or periodontal disease
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Satoko |
| Middle name | |
| Last name | Kakino |
Organization
Tokyo Medical and Dental University (TMDU)
Division name
Pediatric Dentistry, Dental Hospital
Zip code
113-8549
Address
1-chome, 5-45, Yushima, Bunkyo-ku, Tokyo, Japan
TEL
03-5803-5539
satokopd.pedo@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Satoko |
| Middle name | |
| Last name | Kakino |
Organization
Tokyo Medical and Dental University (TMDU)
Division name
Pediatric Dentistry, Dental Hospital
Zip code
113-8549
Address
1-chome, 5-45, Yushima, Bunkyo-ku, Tokyo, Japan
TEL
03-5803-5543
Homepage URL
satokopd.pedo@tmd.ac.jp
Sponsor or person
Institute
Pediatric Dentistry, Dental Hospital, Tokyo Medical and Dental University (TMDU)
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research ethics committee in faculty of dentistry, Tokyo Medical and Dental University
Address
1-chome, 5-45, Yushima, Bunkyo-ku, Tokyo, Japan
Tel
03-3813-6111
infobec@tmd.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
| 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 | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2020 | Year | 04 | Month | 01 | Day |
Date analysis concluded
| 2020 | Year | 07 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 09 | Month | 11 | Day |
Last modified on
| 2019 | Year | 08 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033225
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
