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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000018471
Receipt No. R000019309
Scientific Title Clinical evaluation on the detecting ability using an electrical apical locator
Date of disclosure of the study information 2015/08/01
Last modified on 2016/01/30

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Basic information
Public title Clinical evaluation on the detecting ability using an electrical apical locator
Acronym Clinical evaluation on the detecting ability
Scientific Title Clinical evaluation on the detecting ability using an electrical apical locator
Scientific Title:Acronym Clinical evaluation on the detecting ability
Region
Japan

Condition
Condition dental choronic pain
Classification by specialty
Dental medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We would like to find no difference on the detecting ability between an electrical apex locator and dental CT.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes We detect the height and direction of lateral canala, and compare those data between apex loactor and dental CT.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control No treatment
Stratification YES
Dynamic allocation YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking YES
Concealment Central registration

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Device,equipment
Interventions/Control_1 Detecting of lateral canal using an electrical root canal meter
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
12 years-old <=
Age-upper limit
90 years-old >=
Gender Male and Female
Key inclusion criteria Healthy person
Person possessses the estmating ability about pain
We find the lateral canalin their canal
Key exclusion criteria Personn has difficulties in communicating with other person
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shigeru Shoji
Organization Tohoku University Hospital
Division name Department of Periodontics
Zip code
Address 4-1 Seiryo-machi, Aobaku, Sendai, Miyagi Prefecture
TEL 022-717-8334
Email shoji@dent.tohoku.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Keiichi Sasaki
Organization Tohoku University Graduate School
Division name Dentistry
Zip code
Address 4-1 Seiryo-machi, Aobaku, Sendai, Miyagi Prefecture
TEL 022-717-8368
Homepage URL
Email keii@dent.tohoku.ac.jp

Sponsor
Institute Department of Periodontology, Tohoku University Hospital
Institute
Department

Funding Source
Organization The Yoshida MFG Co. Ltd
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Oka Dental Clinic
Nigatake White Dental Clinic
Name of secondary funder(s)

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 東北大学病院(宮城県) Tohoku University Hospital (Miyagi Prefecture)

Other administrative information
Date of disclosure of the study information
2015 Year 08 Month 01 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 Enrolling by invitation
Date of protocol fixation
2015 Year 07 Month 24 Day
Date of IRB
Anticipated trial start date
2015 Year 08 Month 01 Day
Last follow-up date
2016 Year 01 Month 31 Day
Date of closure to data entry
2016 Year 02 Month 15 Day
Date trial data considered complete
2016 Year 02 Month 28 Day
Date analysis concluded
2016 Year 03 Month 29 Day

Other
Other related information

Management information
Registered date
2015 Year 07 Month 29 Day
Last modified on
2016 Year 01 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019309

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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