UMIN-CTR Clinical Trial

Basic information
Public title	The study on the anesthetic range to the buccal nerve in inferior alveolar nerve block
Acronym	The study on the anesthetic range to the buccal nerve in inferior alveolar nerve block
Scientific Title	The study on the anesthetic range to the buccal nerve in inferior alveolar nerve block
Scientific Title:Acronym	The study on the anesthetic range to the buccal nerve in inferior alveolar nerve block
Region	Japan

Condition
Condition	Oral surgical patients as indication for inferior alveolar nerve block
Classification by specialty	Anesthesiology Oral surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine the region of inferior alveolar nerve, buccal nerve,and lingual nerve using inferior alveolar nerve block
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The anesthetic range of the buccal gingivaand buccal mucosa after inferior alveolar nerve block
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	One is mandible transmission anesthesia. This way block the inferior alveolar nerve near the mandibular foramen.
Interventions/Control_2	The way is a local anesthetic is injected into the pterygomandibular space in front of the mandible.And, this can block the inferior alveolar nerve by diffusing backward and upward in pterygomandibular space.
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	16 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1, patients who are indicated for lower alveolar neurotransmission anesthesia 2. Patients who need surgery for mandibular molars 3, patients who participated in clinical research at their own will and received written consent
Key exclusion criteria	1, Patients under 16 years old 2, patients with allergy and hypersensitivity to the drugs 3, Patients who already have paresthesia in the lower alveolar innervation area from preoperative 4, Other patients judged unsuitable by chief researchers
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Shota Middle name Last name Tsukimoto
Organization	Kindai university faculty of medicine
Division name	Department of anesthesiology
Zip code	5898511
Address	377-2,Ono-higashi,Osakasayama,Osaka
TEL	072-366-0221
Email	hnghm1109@yahoo.co.jp

Public contact
Name of contact person	1st name Shota Middle name Last name Tsukimoto
Organization	Kindai university faculty of medicine
Division name	Department of anesthesiology
Zip code	5898511
Address	377-2,Ono-higashi,Osakasayama,Osaka
TEL	072-366-0221
Homepage URL
Email	hnghm1109@yahoo.co.jp

Sponsor
Institute	Kindai university faculty of medicine
Institute
Department

Funding Source
Organization	Self-funding and individual research expenses
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	Kindai university faculty of medicine of Ethics Committe
Address	377-2,Ono-higashi,Osakasayama,Osaka
Tel	072-366-0221
Email	zizen@med.kindai.ac.jp

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	2017 Year 05 Month 22 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	2017 Year 02 Month 20 Day
Date of IRB	2017 Year 05 Month 18 Day
Anticipated trial start date	2017 Year 05 Month 01 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	2017 Year 05 Month 18 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=R000030213