UMIN-CTR Clinical Trial

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	Completed
Date of protocol fixation	2017 Year 12 Month 27 Day
Date of IRB	2018 Year 01 Month 18 Day
Anticipated trial start date	2018 Year 02 Month 01 Day
Last follow-up date	2021 Year 09 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	2018 Year 01 Month 21 Day
Last modified on	2021 Year 11 Month 16 Day

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