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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000038544
Receipt No. R000043924
Scientific Title Preliminary examination of tongue coating removal effect using oral mucosa oxidol or gargle using the number of bacteria on the tongue as an index
Date of disclosure of the study information 2019/11/11
Last modified on 2019/11/11

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Basic information
Public title Preliminary examination of tongue coating removal effect using oral mucosa oxidol or gargle using the number of bacteria on the tongue as an index
Acronym Examination of tongue coating removal effect using gargle
Scientific Title Preliminary examination of tongue coating removal effect using oral mucosa oxidol or gargle using the number of bacteria on the tongue as an index
Scientific Title:Acronym Examination of tongue coating removal effect using gargle
Region
Japan

Condition
Condition Healthy person
Classification by specialty
Dental medicine Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the clinical effect of various mouthwashes on the tongue
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Bacterial counts on the tongue after tongue cleaning
Key secondary outcomes Bacterial count in saliva after tongue cleaning

Base
Study type Interventional

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

Intervention
No. of arms 4
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Group using Oxol for oral mucosa when cleaning on the tongue(Cleaning only once)
Interventions/Control_2 Group using poppydon iodine for gargle adjusted to the conventional concentration when cleaning on the tongue(Cleaning only once)
Interventions/Control_3 Group using benzalkonium chloride for gargle adjusted to conventional concentration when cleaning on tongue(Cleaning only once)
Interventions/Control_4 Group that uses water to clean the tongue(Cleaning only once)
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria The indicated gargle can be made
Key exclusion criteria When the consent of the person cannot be obtained.
Patients with a history of hypersensitivity to iodine.
Patients with a history of hypersensitivity to benzalkonium chloride.
Patients with a history of discomfort due to the use of oxidol for oral mucosa.
Target sample size 35

Research contact person
Name of lead principal investigator
1st name Madoka
Middle name
Last name Funahara
Organization School of Oral Health Sciences
Kyushu Dental University
Division name Unit of Education on Health Promotion
Zip code 803-8580
Address 2-6-1, Manazuru, Kokurakita-ku, Kitakyushu, Japan
TEL 093-285-3109
Email r17funahara@fa.kyu-dent.ac.jp

Public contact
Name of contact person
1st name Madoka
Middle name
Last name Funahara
Organization School of Oral Health Sciences Kyushu Dental University
Division name Unit of Education on Health Promotion
Zip code 803-8580
Address 2-6-1, Manazuru, Kokurakita-ku, Kitakyushu, Japan
TEL 093-285-3109
Homepage URL
Email r17funahara@fa.kyu-dent.ac.jp

Sponsor
Institute Unit of Education on Health Promotion, School of Oral Health Sciences Kyushu Dental University
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Ethics Review Committee, Kyushu Dental University
Address 2-6-1, Manazuru, Kokurakita-ku, Kitakyushu, Japan
Tel 093-285-3011
Email gakusei@kyu-dent.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

Other administrative information
Date of disclosure of the study information
2019 Year 11 Month 11 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 Enrolling by invitation
Date of protocol fixation
2019 Year 05 Month 01 Day
Date of IRB
2019 Year 06 Month 03 Day
Anticipated trial start date
2019 Year 11 Month 11 Day
Last follow-up date
2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 11 Month 11 Day
Last modified on
2019 Year 11 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043924

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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