UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002596 |
|---|---|
| Receipt number | 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 19:57:37 |
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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
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
asami@ngt.ndu.ac.jp
Sponsor or person
Institute
The Nippon Dental University school of Life Dentistry at Niigata
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003163
