UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002283
Receipt No. R000002782
Scientific Title A chemical on the antimicrobial prevention during tooth extraction in the patients with oral anti coagulation.
Date of disclosure of the study information 2009/08/03
Last modified on 2013/02/08

* 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 A chemical on the antimicrobial prevention during tooth extraction in the patients with oral anti coagulation.
Acronym A chemical on the antimicrobial prevention during tooth extraction in the patients with oral anti coagulation.
Scientific Title A chemical on the antimicrobial prevention during tooth extraction in the patients with oral anti coagulation.
Scientific Title:Acronym A chemical on the antimicrobial prevention during tooth extraction in the patients with oral anti coagulation.
Region
Japan

Condition
Condition Caries
Periapical periodontitis
Periodontitis
Classification by specialty
Oral surgery Dental medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Many patients who are administered warfarin continuously have had prosthetic valve replacement before. Therefore, at the time of extraction, preoperative administration of antibiotic for the patients is recommended for the sake of preventing infectious endocarditis, moreover, postextraction bleeding is concerned due to anticoaglation.
In this study, Zithromac SR general blood level and local blood level at extraction cavity after preoperative administration is going to be measured during extraction. In addition, we are going to verify how preoperative administration of Zithromac SR influences the effect of warfarin(PT-INR).
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes PT-INR
existence or nonexistence of postexraction bleeding
chemical blood level
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 preoperative administration of ZithromacSR
Interventions/Control_2 preoperative administration of Sawacillin
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria continuous administration of warfarin
Key exclusion criteria nothing
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroshi kurita
Organization Shinshu University School of Medicine, Matsumoto, Japan
Division name Department of Dentistry and Oral Surgery
Zip code
Address 3-1-1 Asahi, Mtatsumoto-shi, Nagano-ken, JAPAN
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Shinshu University School of Medicine, Matsumoto, Japan
Division name Department of Dentistry and Oral Surgery
Zip code
Address
TEL
Homepage URL
Email

Sponsor
Institute Hiroshi Kurita
Institute
Department

Funding Source
Organization Shinshu University School of Medicine, Matsumoto, Japan
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
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 08 Month 03 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
2009 Year 07 Month 06 Day
Date of IRB
Anticipated trial start date
2009 Year 08 Month 01 Day
Last follow-up date
2010 Year 03 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 08 Month 03 Day
Last modified on
2013 Year 02 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002782

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.