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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000007480
Receipt No. 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

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

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
URL(English) https://upload.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


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