UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The use of ultrasound guidance for inferior alveolar nerve block.
Title of the study (Brief title)	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	Tomoka Matsumura
Organization	Tokyo Medical and Dental university Dental hospital
Division name	Dental Anesthesiology
Address	1-5-45 Yushima Bunkyou-ku Tokyo Japan.
TEL	03-5803-5549
Email	tomoanph@tmd.ac.jp

Public contact
Name of contact person	Tomoka Matsumura
Organization	Tokyo Medical and Dental University Dental Hospital.
Division name	Dental Anesthesiology
Address	1-5-45 Yushima Bunkyou-ku Tokyo Japan.
TEL	03-5803-5549
Homepage URL
Email	tomoanph@tmd.ac.jp

Sponsor
Institute	Tokyo Medical and Dental univeresity
Institute
Department

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)

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

Progress
Recruitment status	Terminated
Date of protocol fixation	2016 Year 06 Month 27 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000026378