UMIN-CTR Clinical Trial

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	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000038531