UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study of pain control on Impacted Mandibular Third Molar
Title of the study (Brief title)	Study of pain control on after opelation
Region	Japan

Condition
Condition	Impacted Mandibular Third Molar
Classification by specialty	Dental medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose is appropriate local anesthetic searching
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	1.Visual Analogue scale 2.Time that pain appears 3.Time to have taken analgesic 4.Number of doses of analgesics
Key secondary outcomes

Base
Study type	Interventional

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

Intervention
No. of arms	3
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	2%lidocaine hydrochloride with 1:80000 adrenaline 3ml:infiltration anesthesia,Extraction of the Impacted Mandibular Third Molar and 2% lidocaine hydrochroride with 1:80000 adrenarine 2ml:conduction anesthesia
Interventions/Control_2	2% lidocaine hydrochloride with 1:80000 adrenaline 3ml:infiltration anesthesia,Extraction of the Impacted Mandibular Third Molar and 0.25% bupivacaine hydrochloride 2ml:conduction anesthesia
Interventions/Control_3	2% lidocaine hydrochloride with 1:80000 adrenaline 3ml:infiltration anesthesia,Extraction of the Impacted Mandibular Third Molar and 0.25% levobupivacaine hydrochloride 2ml:conduction anesthesia
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	There are taken informed concent among Extraction of the Impacted Mandibular Third Molar patient at Nippon Dental University Niigata Hospital
Key exclusion criteria	Patient of two degree or more of ASAclassification Age of under 20 Have a drug Allergy
Target sample size	30

Research contact person
Name of lead principal investigator	Shun Akiniwa
Organization	The Nippon Dental University School of Life Dentistry at Niigata
Division name	Department of Dental Anesthesiology
Address	1-8 Hamaura-cho,Chuo-ku,Niigata
TEL	025-267-1500
Email	ketuago.drums.mapputa2@gmail.com

Public contact
Name of contact person	Kimito Sano
Organization	The Nippon Dental University School of Life Dentistry at Niigata
Division name	Department of Dental Anesthesiology
Address	1-8 Hamaura-cho,Chuo-ku,Niigata
TEL	025-267-1500
Homepage URL
Email	ketuago.drums.mapputa2@gmail.com

Sponsor
Institute	The Nippon Dental University School of Life Dentistry at Niigata
Institute
Department

Funding Source
Organization	None
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	2012 Year 04 Month 25 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 04 Month 24 Day
Anticipated trial start date	2012 Year 05 Month 01 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	Published
URL releasing results
Results
Other related information

Management information
Registered date	2012 Year 04 Month 24 Day
Last modified on	2017 Year 04 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000009231