UMIN-CTR Clinical Trial

Basic information
Public title	Effect of cleaning and gargle after brushing using the number of microorganisms in the oral cavity as an index
Acronym	Effect of cleaning and gargle after brushing using the number of microorganisms in the oral cavity as an index
Scientific Title	Effect of cleaning and gargle after brushing using the number of microorganisms in the oral cavity as an index
Scientific Title:Acronym	Effect of cleaning and gargle after brushing using the number of microorganisms in the oral cavity as an index
Region	Japan

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

Objectives
Narrative objectives1	Using the number of bacteria in saliva as an index, examine the effects of oral cleaning and gargle after brushing.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The number of bacteria in saliva is measured immediately after each method (brushing, cleaning the oral cavity, and gargling with water). The measurement is not invasive and no follow-up is performed after the measurement.
Key secondary outcomes	Medical record survey items (gender, age, medical history, medication status, BMI, number of remaining teeth, presence or absence of mouth breathing, smoking, drinking, oral wetness, plaque, and dental calculus adhesion)

Base
Study type	Interventional

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

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Brushing, cleaning the oral cavity, and gargle with water is performed on healthy subjects.
Interventions/Control_2	The only gargle with water is performed on healthy subjects.
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Can be gargled
Key exclusion criteria	Cannot contain gargle Under 20 years old Oral cancer patients
Target sample size	45

Research contact person
Name of lead principal investigator	1st name Madoka Middle name Last name Funahara
Organization	Kyushu Dental University
Division name	Faculty of Dentistry
Zip code	803-8580
Address	2-6-1, Manazuru, Kitakyushu, Fukuoka
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	Kyusyu Dental University
Division name	Faculty of Dentistry
Zip code	803-8580
Address	2-6-1, Manazuru, Kitakyushu, Fukuoka
TEL	093-285-3109
Homepage URL
Email	r17funahara@fa.kyu-dent.ac.jp

Sponsor
Institute	School of Oral Health Sciences Kyushu Dental University
Institute
Department

Funding Source
Organization	Japan society for the promotion of science
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization

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, 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	2020 Year 12 Month 10 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications
Number of participants that the trial has enrolled	40
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	2020 Year 08 Month 01 Day
Date of IRB	2020 Year 09 Month 10 Day
Anticipated trial start date	2020 Year 12 Month 10 Day
Last follow-up date	2021 Year 12 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	2020 Year 12 Month 02 Day
Last modified on	2022 Year 01 Month 21 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048638