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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000033780
Receipt No. 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 2018/08/16

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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
Email 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
Email s.tsukimoto@med.kindai.ac.jp

Sponsor
Institute Kindai University
Institute
Department

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
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

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 Enrolling by invitation
Date of protocol fixation
2018 Year 05 Month 24 Day
Date of IRB
Anticipated trial start date
2018 Year 08 Month 16 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
2018 Year 08 Month 16 Day
Last modified on
2018 Year 08 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038531

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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