UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002283 |
|---|---|
| Receipt number | 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 20:07:52 |
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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
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
Sponsor or person
Institute
Hiroshi Kurita
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002782
