UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022887 |
|---|---|
| Receipt number | R000026378 |
| Scientific Title | The use of ultrasound guidance for inferior alveolar nerve block. |
| Date of disclosure of the study information | 2016/06/27 |
| Last modified on | 2017/06/26 09:38:55 |
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Basic information
Public title
The use of ultrasound guidance for inferior alveolar nerve block.
Acronym
The use of ultrasound guidance for inferior alveolar nerve block.
Scientific Title
The use of ultrasound guidance for inferior alveolar nerve block.
Scientific Title:Acronym
The use of ultrasound guidance for inferior alveolar nerve block.
Region
| Japan |
Condition
Condition
dental disease
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate the efficacy of the inferior alveolar nerve block with use of ultrasound guidance.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase I
Assessment
Primary outcomes
We assess the effect of ultrasound guidance by using VAS (visual analogue scale) after injection.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Ultrasound guided group
Interventions/Control_2
Peripheral nerve block group
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
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
The healthy people who gave consent to this study.
Key exclusion criteria
People with paralysis on their faces.
People who have anti-clotting drug.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tomoka Matsumura |
Organization
Tokyo Medical and Dental university Dental hospital
Division name
Dental Anesthesiology
Zip code
Address
1-5-45 Yushima Bunkyou-ku Tokyo Japan.
TEL
03-5803-5549
tomoanph@tmd.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomoka Matsumura |
Organization
Tokyo Medical and Dental University Dental Hospital.
Division name
Dental Anesthesiology
Zip code
Address
1-5-45 Yushima Bunkyou-ku Tokyo Japan.
TEL
03-5803-5549
Homepage URL
tomoanph@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental univeresity
Institute
Department
Personal name
Funding Source
Organization
self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 06 | Month | 27 | 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
Terminated
Date of protocol fixation
| 2016 | Year | 06 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 06 | Month | 27 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 06 | Month | 25 | Day |
Last modified on
| 2017 | Year | 06 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026378
