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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000007831
Receipt No. R000009231
Scientific Title Study of pain control on Impacted Mandibular Third Molar
Date of disclosure of the study information 2012/04/25
Last modified on 2017/04/30

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Basic information
Public title Study of pain control on Impacted Mandibular Third Molar
Acronym Study of pain control on after opelation
Scientific Title Study of pain control on Impacted Mandibular Third Molar
Scientific Title:Acronym 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
1st name
Middle name
Last name Shun Akiniwa
Organization The Nippon Dental University School of Life Dentistry at Niigata
Division name Department of Dental Anesthesiology
Zip code
Address 1-8 Hamaura-cho,Chuo-ku,Niigata
TEL 025-267-1500
Email ketuago.drums.mapputa2@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Kimito Sano
Organization The Nippon Dental University School of Life Dentistry at Niigata
Division name Department of Dental Anesthesiology
Zip code
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)

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
2012 Year 04 Month 25 Day

Related information
URL releasing protocol
Publication of results Published

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
2012 Year 04 Month 24 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000009231

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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