UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000009341
Receipt number R000010968
Scientific Title study of the efficacy of the Levobupivacaine in mandibular-foramen conduction anesthesia
Date of disclosure of the study information 2012/11/30
Last modified on 2012/11/28 19:31:28

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Basic information

Public title

study of the efficacy of the Levobupivacaine in mandibular-foramen conduction anesthesia

Acronym

study of an analgesic effect and duration of action

Scientific Title

study of the efficacy of the Levobupivacaine in mandibular-foramen conduction anesthesia

Scientific Title:Acronym

study of an analgesic effect and duration of action

Region

Japan


Condition

Condition

adult

Classification by specialty

Dental medicine Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

It searches about the efficacy in the conduction anesthesia of Levobupivacaine

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

1.anesthesia success rate
2.onset of anesthesia time
3.pulp chamber anesthesia success rate
4.unpleasant frequency at the time of infusion of drug

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit


Blinding

Single blind -participants are blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Mandibular-foramen conduction anesthesia is performed by 2.0mL of 0.25%Levobupivacaine hydrochloride

Interventions/Control_2

Mandibular-foramen conduction anesthesia is performed by 2.0mL of 2%Lidocaine hydrochloride with 1/80000 adrenaline

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

the adult fully explained about this study and consent was got

Key exclusion criteria

the adult fully explained about this study and consent was not got

Target sample size

20


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Tetsuya NAGOH

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


Email



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


Email



Sponsor or person

Institute

The Nippon Dental University School of Life Dentistry at Niigata

Institute

Department

Personal name



Funding Source

Organization

self funding

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

2012 Year 11 Month 30 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

2012 Year 11 Month 29 Day

Date of IRB


Anticipated trial start date

2012 Year 12 Month 01 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 11 Month 15 Day

Last modified on

2012 Year 11 Month 28 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010968


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name