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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000002596
Receipt No. R000003163
Scientific Title Study of pain control on Impacted Mandibular Third Molar
Date of disclosure of the study information 2009/10/07
Last modified on 2009/10/07

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Basic information
Public title Study of pain control on Impacted Mandibular Third Molar
Acronym Study of pain contlol on after opelation
Scientific Title Study of pain control on Impacted Mandibular Third Molar
Scientific Title:Acronym Study of pain contlol 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 reduce of post opelation pain and search of best Local Anesthesia method
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Visual Analgue Scale
Time that pain appears
Time to have taken analgesic
Number of doses of analgesics
Homedynemics ,Plasma Catecholamine
Key secondary outcomes

Base
Study type Interventional

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

Intervention
No. of arms 5
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 2%lidocainehydrochloide with 1:80000 epinephrine 2ml:conduction anesthesia,2%lidocainehydrochloide with 1:80000 epinephrine3ml:infiltration anesthesia and Extraction of the Impacted Mandibular Third Molar
Interventions/Control_2 0.25%Bupivacaine 2.0ml:conduction anesthesia,2%lidocainehydrochloide with 1:80000 epinephrine3.0ml:infiltration anesthesia and Extraction of the Impacted Mandibular Third Molar
Interventions/Control_3 3%prilocaine with 0.03IU felypressin 2.0ml:conduction anesthesia,3%prilocaine with 0.03IU felypressin 3.0ml:infiltration anesthesia and Extraction of the Impacted Mandibular Third Molar
Interventions/Control_4 0.25%Bupivacaine 2.0ml:conduction anesthesia,0.25%prilocaine with 0.03IU felypressin 3.0ml:infiltration anesthesia and Extraction of the Impacted Mandibular Third Molar
Interventions/Control_5 2%lidocainehydrochloide with 1:80000 epinephrine3.0ml:infiltration anesthesia and Extraction of the Impacted Mandibular Third Molar,0.25%Bupivacaine 2.0ml(conduction anesthesia)
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 Extration of the Impacted Mandibular Third Molar patient ato Nippon Dental University Niigata Hospital
Key exclusion criteria Patient of two degree or more of ASA classification
Age of under 20
Have a drug Allergy
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Asami Akiyama
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
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization The Nippon Dental University school of Life Dentistry at Niigata
Division name Department of Dental Anesthesiology
Zip code
Address
TEL
Homepage URL
Email asami@ngt.ndu.ac.jp

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
2009 Year 10 Month 07 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 No longer recruiting
Date of protocol fixation
2009 Year 09 Month 30 Day
Date of IRB
Anticipated trial start date
2009 Year 10 Month 01 Day
Last follow-up date
2010 Year 12 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 10 Month 07 Day
Last modified on
2009 Year 10 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003163

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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