UMIN-CTR Clinical Trial

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
Email	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
Email	geka0329@dent.tohoku.ac.jp

Sponsor
Institute	Tohoku University
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054473