UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018336 |
|---|---|
| Receipt number | R000021215 |
| Scientific Title | Effects of dexmedetomidine added to ridocaine for inferior alveolar nerve block duration,double blind,randomized trial |
| Date of disclosure of the study information | 2015/07/16 |
| Last modified on | 2015/07/23 12:05:41 |
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Basic information
Public title
Effects of dexmedetomidine added to ridocaine for inferior alveolar nerve block duration,double blind,randomized trial
Acronym
Effects of dexmedetomidine added to ridocaine for inferior alveolar nerve block
Scientific Title
Effects of dexmedetomidine added to ridocaine for inferior alveolar nerve block duration,double blind,randomized trial
Scientific Title:Acronym
Effects of dexmedetomidine added to ridocaine for inferior alveolar nerve block
Region
| Japan |
Condition
Condition
healthy adult volunteers
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
It was reported duration for lidocaine extends DEX in the study for rats.
We compare the duration when we performed inferior alveolar block injection with DEX added to lidocaine in this study when we go for lidocaine single taste.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
We measure the sharp pain threshold using a pulp tester after inferior alveolar nerve block every ten minutes until 120 minutes.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Group L:2%lidocaine(Saline 1ml with 4%lidocaine 1ml)
Inferior alveolar nerve block is performed by group L
Leave the interval more than one week
Group DL:10microgram/mlDEX added 2%lidocaine(DEX200 microgram 1ml with saline 3ml with 4%lidocaine 4ml)
Inferior alveolar nerve block is performed by group DL
Interventions/Control_2
Group DL:10microgram/mlDEX added 2%lidocaine(DEX200 microgram 1ml with saline 3ml with 4%lidocaine 4ml)
Inferior alveolar nerve block is performed by group DL
Leave the interval more than one week
Group L:2%lidocaine(Saline 1ml with 4%lidocaine 1ml)
Inferior alveolar nerve block is performed by group L
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Lower central incisor,first premolar and first molar of the healthy adult volunteer fully explained this study and consent was got
Key exclusion criteria
1.In the case of nonvital tooth
2.When there is untreated caries
3.When when the restoration thing that is higher than MOD inlay is attached
4here is hyperesthesia
In the case of 1~4 is second premolar,second molar
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Katsuhisa Sunada |
Organization
The Nippon Dental University school of Life Dentistry at Tokyo
Division name
Department of Dental AnesthesiologyThe Nippon Dental University school of Life Dentistry at Tokyo
Zip code
Address
1-9-20Fujimi,Chiyoda-ku,Tokyo
TEL
03(3261)8311
katsu.sunada@nifty.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Katsuhisa Sunada |
Organization
The Nippon Dental University school of Life Dentistry at Tokyo
Division name
Department of Dental AnesthesiologyThe Nippon Dental University school of Life Dentistry at Tokyo
Zip code
Address
1-9-20Fujimi,Chiyoda-ku,Tokyo
TEL
03(3261)8311
Homepage URL
katsu.sunada@nifty.com
Sponsor or person
Institute
The Nippon Dental University school of Life Dentistry at Tokyo
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
| 2015 | Year | 07 | Month | 16 | 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
Preinitiation
Date of protocol fixation
| 2015 | Year | 07 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 07 | Month | 16 | 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
| 2015 | Year | 07 | Month | 16 | Day |
Last modified on
| 2015 | Year | 07 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021215
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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