UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008969 |
|---|---|
| Receipt number | 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 22:45:35 |
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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
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
fujiwara@dent.kyushu-u.ac.jp
Sponsor or person
Institute
Department of Dental Anesthesiology Faculty of Dental Science
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010519
