UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000007480
Receipt number R000008821
Scientific Title Hemostatic management of tooth extraction in patients on antiplatelet therapy
Date of disclosure of the study information 2012/03/12
Last modified on 2012/03/09 17:48:01

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Basic information

Public title

Hemostatic management of tooth extraction in patients on antiplatelet
therapy

Acronym

Tooth extraction on antiplatelet therapy patients

Scientific Title

Hemostatic management of tooth extraction in patients on antiplatelet
therapy

Scientific Title:Acronym

Tooth extraction on antiplatelet therapy patients

Region

Japan


Condition

Condition

Antiplatelet therapy patients

Classification by specialty

Oral surgery Dental medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Antiplatelet therapy patients' platelet adhesiveness is evaluated and relation with the arrest of hemorrhage after tooth extraction is investigated.

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase III


Assessment

Primary outcomes

ASPI test
ADP test
TRAP test
plate

Key secondary outcomes

red blood cell
white blood cell


Base

Study type

Interventional


Study design

Basic design

Factorial

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Diagnosis

Type of intervention

Device,equipment Maneuver

Interventions/Control_1

Hemostatic management of tooth extraction

Interventions/Control_2

Hemorrhaic of tooth extraction

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

Antiplatelet therapy patients

Key exclusion criteria

It does not have the ability on which it agrees with a patient.

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name yasushi nagao

Organization

Showa University Dental Hospital

Division name

Dental Anesthesia

Zip code


Address

2-1-1,Kitasenzoku,Ohta-ku,Tokyo,145-8515 Japan

TEL

03-3787-1151

Email



Public contact

Name of contact person

1st name
Middle name
Last name yasushi nagao

Organization

Showa University Dental Hospital

Division name

Dental Anesthesia

Zip code


Address

2-1-1,Kitasenzoku,Ohta-ku,Tokyo,145-8515 Japan

TEL

03-3787-1151

Homepage URL


Email

nagao@dent.showa-u.ac.jp


Sponsor or person

Institute

Department of Dental Anesthesia,School of Dentistry,Showa University Dental Hospital

Institute

Department

Personal name



Funding Source

Organization

Department of Dental Anesthesia,School of Dentistry,Showa University Dental Hospital

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



Secondary IDs

Secondary IDs

YES

Study ID_1

2011-044

Org. issuing International ID_1

Showa University

Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions

昭和大学歯科病院(東京都)


Other administrative information

Date of disclosure of the study information

2012 Year 03 Month 12 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 03 Month 12 Day

Date of IRB


Anticipated trial start date

2012 Year 03 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 03 Month 09 Day

Last modified on

2012 Year 03 Month 09 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008821


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name