UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047842 |
|---|---|
| Receipt number | R000054473 |
| Scientific Title | Intervention study on proper antibiotic use in tooth extraction |
| Date of disclosure of the study information | 2022/05/24 |
| Last modified on | 2022/05/24 13:23:53 |
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Basic information
Public title
Intervention study on proper antibiotic use in tooth extraction
Acronym
Intervention study of tooth extraction and antibiotic use
Scientific Title
Intervention study on proper antibiotic use in tooth extraction
Scientific Title:Acronym
Intervention study of tooth extraction and antibiotic use
Region
| Japan |
Condition
Condition
Mandibular impacted wisdom tooth
Classification by specialty
| Oral surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Safety of mandibular impacted wisdom tooth extraction under premedication
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Swelling of the extraction wound
Key secondary outcomes
Presence or absence of pain and drainage
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are 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
Amoxicillin 250 mg administration group 1 hour before tooth extraction
Interventions/Control_2
Amoxicillin 750 mg / day x 3 days after tooth extraction group
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
| 18 | years-old | <= |
Age-upper limit
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients who visited our department for tooth extraction request with mandibular impacted wisdom tooth
Key exclusion criteria
Amoxicillin allergy
During pregnancy
Risk of drug-induced jawbone necrosis
Target sample size
240
Research contact person
Name of lead principal investigator
| 1st name | Yushi |
| Middle name | |
| Last name | Ezoe |
Organization
Tohoku University
Division name
Divison of Oral Surgery
Zip code
9808574
Address
Seiryoucho 1-1, Aoba ward, Sendai, Miyagi
TEL
0227178350
geka0329@dent.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Yushi |
| Middle name | |
| Last name | Ezoe |
Organization
Tohoku University
Division name
Divison of Oral Surgery
Zip code
9808574
Address
Seiryoucho 1-1, Aoba ward, Sendai, Miyagi
TEL
0227178350
Homepage URL
geka0329@dent.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
Tohoku University
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
Ethics Committee Tohoku University Graduate School of Medicine
Address
Seiryoucho 2-1, Aoba ward, Sendai, Miyagi
Tel
0227178007
ec@rinri.hosp.tohoku.ac.jp
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
東北大学病院（宮城県）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 05 | Month | 24 | 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
| 2022 | Year | 05 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2022 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 10 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 05 | Month | 24 | Day |
Last modified on
| 2022 | Year | 05 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054473
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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