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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000018336
Receipt No. 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

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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
Email 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
Email katsu.sunada@nifty.com

Sponsor
Institute The Nippon Dental University school of Life Dentistry at Tokyo
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021215

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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