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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000029082
Receipt No. 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

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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
Email 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
Email satokopd.pedo@tmd.ac.jp

Sponsor
Institute Pediatric Dentistry, Dental Hospital, Tokyo Medical and Dental University (TMDU)
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033225

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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