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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000030919
Receipt No. R000035304
Scientific Title Bacteriological effect of mouth wash including a chemical sterilant during general anesthesia : comparison between two different formulations
Date of disclosure of the study information 2018/01/22
Last modified on 2018/01/21

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Basic information
Public title Bacteriological effect of mouth wash including a chemical sterilant during general anesthesia : comparison between two different formulations
Acronym Effect of mouth wash during general anesthesia
Scientific Title Bacteriological effect of mouth wash including a chemical sterilant during general anesthesia : comparison between two different formulations
Scientific Title:Acronym Effect of mouth wash during general anesthesia
Region
Japan

Condition
Condition Patients who undergo general anesthesia
Classification by specialty
Surgery in general Dental medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To assess bacteriological effect of mouth wash including iodine or CPC.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Change of microflora in the oral mouth
Key secondary outcomes

Base
Study type Interventional

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

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine Other
Interventions/Control_1 oral wash using iodine solution solution)
Interventions/Control_2 oral wash using CPC solution
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
1 years-old <=
Age-upper limit
100 years-old >
Gender Male and Female
Key inclusion criteria Patients who under go general anesthesia
Patients who visit oral care center before operation
Patients who had not use antibiotics since a week ago
Patients who had ten more dentition
Patients who can irrigate mouth for more than 20 seconds
Patients who agree to participate the study
Key exclusion criteria Patients who had an operation at head and neck region
Patients who need artificial ventilation after the surgery
Patients who have allergy for iodine or CPC
Diabetic patient
Patients who are judged as not suitable for the study
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroshi Kurita
Organization Shinshu University
Division name Department of Dentistry and Oral Surgery, School of Medicine
Zip code
Address Asahi 3-1-1, Matsumoto, 390-8621, JAPAN
TEL 0263-37-2677
Email hkurita@shinshu-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroshi Kurita
Organization Shinshu University
Division name Department of Dentistry and Oral Surgery, School of Medicine
Zip code
Address Asahi 3-1-1, Matsumoto, 390-8621, JAPAN
TEL 0163-37-2677
Homepage URL
Email hkurita@shinshu-u.ac.jp

Sponsor
Institute Shinshu University
Institute
Department

Funding Source
Organization Sunster Co.
Organization
Division
Category of Funding Organization Profit organization
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
2018 Year 01 Month 22 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
2017 Year 12 Month 27 Day
Date of IRB
Anticipated trial start date
2018 Year 02 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
2018 Year 01 Month 21 Day
Last modified on
2018 Year 01 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035304

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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