UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000018471
Receipt number 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 11:38:04

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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 or person

Institute

Department of Periodontology, Tohoku University Hospital

Institute

Department

Personal name



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

Value
https://center6.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