UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000002596
Receipt number R000003163
Scientific Title Study of pain control on Impacted Mandibular Third Molar
Date of disclosure of the study information 2009/10/07
Last modified on 2009/10/07 19:57:37

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Study of pain control on Impacted Mandibular Third Molar

Acronym

Study of pain contlol on after opelation

Scientific Title

Study of pain control on Impacted Mandibular Third Molar

Scientific Title:Acronym

Study of pain contlol on after opelation

Region

Japan


Condition

Condition

Impacted Mandibular Third Molar

Classification by specialty

Dental medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpose is reduce of post opelation pain and search of best Local Anesthesia method

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Visual Analgue Scale
Time that pain appears
Time to have taken analgesic
Number of doses of analgesics
Homedynemics ,Plasma Catecholamine

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit


Blinding

Double blind -all involved are blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

5

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

2%lidocainehydrochloide with 1:80000 epinephrine 2ml:conduction anesthesia,2%lidocainehydrochloide with 1:80000 epinephrine3ml:infiltration anesthesia and Extraction of the Impacted Mandibular Third Molar

Interventions/Control_2

0.25%Bupivacaine 2.0ml:conduction anesthesia,2%lidocainehydrochloide with 1:80000 epinephrine3.0ml:infiltration anesthesia and Extraction of the Impacted Mandibular Third Molar

Interventions/Control_3

3%prilocaine with 0.03IU felypressin 2.0ml:conduction anesthesia,3%prilocaine with 0.03IU felypressin 3.0ml:infiltration anesthesia and Extraction of the Impacted Mandibular Third Molar

Interventions/Control_4

0.25%Bupivacaine 2.0ml:conduction anesthesia,0.25%prilocaine with 0.03IU felypressin 3.0ml:infiltration anesthesia and Extraction of the Impacted Mandibular Third Molar

Interventions/Control_5

2%lidocainehydrochloide with 1:80000 epinephrine3.0ml:infiltration anesthesia and Extraction of the Impacted Mandibular Third Molar,0.25%Bupivacaine 2.0ml(conduction anesthesia)

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

There are taken informed concent among Extration of the Impacted Mandibular Third Molar patient ato Nippon Dental University Niigata Hospital

Key exclusion criteria

Patient of two degree or more of ASA classification
Age of under 20
Have a drug Allergy

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Asami Akiyama

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

asami@ngt.ndu.ac.jp


Sponsor or person

Institute

The Nippon Dental University school of Life Dentistry at Niigata

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


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

2009 Year 10 Month 07 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

No longer recruiting

Date of protocol fixation

2009 Year 09 Month 30 Day

Date of IRB


Anticipated trial start date

2009 Year 10 Month 01 Day

Last follow-up date

2010 Year 12 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2009 Year 10 Month 07 Day

Last modified on

2009 Year 10 Month 07 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003163


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name