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
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
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
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
