UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030919 |
|---|---|
| Receipt number | 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 | 2021/11/16 08:33:16 |
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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
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
hkurita@shinshu-u.ac.jp
Sponsor or person
Institute
Shinshu University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035304
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
