UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033780 |
|---|---|
| Receipt number | R000038531 |
| Scientific Title | Area extent of anesthesia in buccal nerve innervation area by the anterior technique for inferior alveolar nerve block: clinical evaluation and magnetic resonance imaging study |
| Date of disclosure of the study information | 2018/08/16 |
| Last modified on | 2020/11/19 11:11:13 |
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Basic information
Public title
Area extent of anesthesia in buccal nerve innervation area by the anterior technique for inferior alveolar nerve block: clinical evaluation and magnetic resonance imaging study
Acronym
Area extent of anesthesia in buccal nerve innervation area by the anterior technique for inferior alveolar nerve block: clinical evaluation and magnetic resonance imaging study
Scientific Title
Area extent of anesthesia in buccal nerve innervation area by the anterior technique for inferior alveolar nerve block: clinical evaluation and magnetic resonance imaging study
Scientific Title:Acronym
Area extent of anesthesia in buccal nerve innervation area by the anterior technique for inferior alveolar nerve block: clinical evaluation and magnetic resonance imaging study
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Anesthesiology | Oral surgery | Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In oral surgery in the mandibular region, a sufficient range of pain relief is important to prevent pain and complications involving local anesthetics. The purpose of this study is to examine the anesthetic response to the buccal nerve by clarifying the tissue dynamics of the local anesthetic in the conventional technique and in the anterior technique by magnetic resonance imaging for the same subject.
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
1)Intra-tissue pharmacokinetics of local anesthetic by MRI after the anterior technique
2)Comparison of images with the conventional technique and the anterior technique
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
The conventional technique for inferior alveolar nerve block
Interventions/Control_2
The anterior technique for inferior alveolar nerve block
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Healthy adults over 20 years old who understand the purpose of this research and participate voluntarily
2.Gender does not matter
Key exclusion criteria
1) If you have allergies and hypersensitivity drugs to use
2) The MRI can not be performed, such as internal metals
3) Those who refuse the inferior alveolar nerve block
4) Persons with perceptual abnormality (obtuse, paralysis etc.) in alveolar innervation area before participation in research
5) Patient who needs treatment
6) Other who judged that other principal investigators are inappropriate
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shota Tsukimoto |
Organization
Kindai university faculty of medicine
Division name
Department of Anesthesiology
Zip code
Address
377-2, Ohno-higashi, Osaka-sayama, Osaka
TEL
072-366-0221
s.tsukimoto@med.kindai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shota Tsukimoto |
Organization
Kindai university faculty of medicine
Division name
Department of Anesthesiology
Zip code
Address
377-2, Ohno-higashi, Osaka-sayama, Osaka
TEL
072-366-0221
Homepage URL
http://www.med.kindai.ac.jp/anes/clinical_study.html
s.tsukimoto@med.kindai.ac.jp
Sponsor or person
Institute
Kindai University
Institute
Department
Personal name
Funding Source
Organization
Self-findings
Organization
Division
Category of Funding Organization
Other
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
| 2018 | Year | 08 | Month | 16 | 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
Completed
Date of protocol fixation
| 2018 | Year | 05 | Month | 24 | Day |
Date of IRB
| 2018 | Year | 07 | Month | 10 | Day |
Anticipated trial start date
| 2018 | Year | 08 | Month | 16 | Day |
Last follow-up date
| 2029 | Year | 04 | Month | 16 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 08 | Month | 16 | Day |
Last modified on
| 2020 | Year | 11 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038531
