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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000008969
Receipt No. R000010519
Scientific Title Study of the local-anesthetic-effect time and the range of a lidocaine with epinephrine
Date of disclosure of the study information 2012/09/24
Last modified on 2014/09/22

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Basic information
Public title Study of the local-anesthetic-effect time and the range of a lidocaine with epinephrine
Acronym Study of the local-anesthetic-effect time and the range of a lidocaine
Scientific Title Study of the local-anesthetic-effect time and the range of a lidocaine with epinephrine
Scientific Title:Acronym Study of the local-anesthetic-effect time and the range of a lidocaine
Region
Japan

Condition
Condition A healthy volunteer without a sickness
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is realization of an operation of a more suitable local anesthetic in dental treatment.
Basic objectives2 Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes It is each test solution 1 mL to the root-tip equivalent part gingival of a left-side up-and-down jaw fang.Until it recovers the range in every 10 minutes from an operation using the 2-point-discrimination method of transfusion .6 mm on the same level as record . 2-hour and 30 minutes, or perception's time until sense of pain of labia oris is recovered by record . Pinprick method study-before by a side periosteum narcosis,It recorded, the front masque photography was taken at the time of the termination of termination ., and the variation of the range was evaluated based on marking at the time of each measure.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -but assessor(s) are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine Other
Interventions/Control_1 2%lidocaine, 2%lidocaine with 1/80000epinehrine, 2%lidocaine with 1/200000epinehrine
Interventions/Control_2
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
40 years-old >=
Gender Male and Female
Key inclusion criteria The healthy volunteer up to 20-40 years old
Key exclusion criteria (1) Those who have an allergy in a local anesthetic

(2) Those who have a sickness of the circulatory system

(3) Those who have a sugar diabetes

(4) Those who have a toxic goiter

(5) Those who have serious hepatic function disorder and renal impairment

(6) In addition, those who judged that a test doctor in attendance was unsuitable
Target sample size 18

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takeshi Yokoyama
Organization Kyushu university
Division name Department of Dental Anesthesiology Faculty of Dental Science
Zip code
Address 3-1-1 Maidashi Higashi-ku Fukuoka
TEL 092-642-6480
Email yokoyama@dent.kyushu-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shigeki Fujiwara
Organization Kyushu university
Division name Department of Dental Anesthesiology Faculty of Dental Science
Zip code
Address 3-1-1 Maidashi Higashi-ku Fukuoka
TEL 092-642-6480
Homepage URL
Email fujiwara@dent.kyushu-u.ac.jp

Sponsor
Institute Department of Dental Anesthesiology Faculty of Dental Science
Institute
Department

Funding Source
Organization Kyushu university
Organization
Division
Category of Funding Organization Other
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 09 Month 24 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 Completed
Date of protocol fixation
2011 Year 03 Month 10 Day
Date of IRB
Anticipated trial start date
2011 Year 05 Month 24 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 09 Month 24 Day
Last modified on
2014 Year 09 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010519

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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