UMIN-CTR Clinical Trial

Basic information
Public title	A verification study on plaque formation by using a dentifrice
Acronym	Study on plaque formation by using a dentifrice
Scientific Title	Study on plaque formation by using a dentifrice
Scientific Title:Acronym	Study on plaque formation by using a dentifrice
Region	Japan

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

Objectives
Narrative objectives1	To confirm the effect of toothbrushing with a dentifrice on plaque formation for healthy subjects
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Dental plaque evaluation after a test dentifrice use
Key secondary outcomes	Intraoral photos after test dentifrice use. Number of bacteria in plaque after test dentifrice use. Amount of LPS in plaque after test dentifrice use. Cytokine induction by plaque after test dentifrice use. Cell stimulation by plaque after test dentifrice use.

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Other
Interventions/Control_1	Toothbrushing with test toothpaste for 1 week , wash out for 1 week .Toothbrushing with placebo toothpaste for 1 week
Interventions/Control_2	Toothbrushing with placebo toothpaste for 1 week , wash out for 1 week . Toothbrushing with test toothpaste for 1 week
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	65 years-old >
Gender	Male and Female
Key inclusion criteria	Subjects who are undergoing dental maintenance at Nagasaki University Hospital
Key exclusion criteria	Subjects with severe liver and kidney dysfunction Subjects with drug hypersensitivity constitution Subjects who have systemic disease and are being treated at a clinic Subjects with xerostomia Smoker Subjects who took antibiotics within one month Subjects who participated other clinical study within 4 months Female who are pregnant and lactating Subjects deemed inappropriate to participate in this study by the principle investigator
Target sample size	50

Research contact person
Name of lead principal investigator	1st name atsutoshi Middle name Last name yosimura
Organization	Nagasaki University Graduate School
Division name	Biomedical Sciences Department of Periodontology and Endodontology Professor
Zip code	8528102
Address	1-7-1 Sakamoto, Nagasaki-shi, Nagasaki, 852-8501, JAPAN
TEL	+81-95-819-7681
Email	ayoshi@nagasaki-u.ac.jp

Public contact
Name of contact person	1st name atsutoshi Middle name Last name yoshimura
Organization	Nagasaki University Graduate School
Division name	Biomedical Sciences Department of Periodontology and Endodontology Professor
Zip code	8528102
Address	1-7-1 Sakamoto, Nagasaki-shi, Nagasaki, 852-8501, JAPAN
TEL	+81-95-819-7681
Homepage URL
Email	ayoshi@nagasaki-u.ac.jp

Sponsor
Institute	Nagasaki University Graduate School
Institute
Department

Funding Source
Organization	Kao Corporation
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	Nagasaki University Graduate School
Address	1-7-1, sakamoto, nagsaki, nagasaki
Tel	+81-95-819-7198
Email	gakujutu_gakuji@ml.nagasaki-u.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	長崎大学病院

Other administrative information
Date of disclosure of the study information	2020 Year 06 Month 07 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	50
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	Open public recruiting
Date of protocol fixation	2020 Year 03 Month 01 Day
Date of IRB	2020 Year 03 Month 24 Day
Anticipated trial start date	2020 Year 04 Month 01 Day
Last follow-up date	2020 Year 11 Month 30 Day
Date of closure to data entry	2021 Year 12 Month 31 Day
Date trial data considered complete	2021 Year 12 Month 31 Day
Date analysis concluded	2021 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date	2020 Year 06 Month 02 Day
Last modified on	2020 Year 06 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044883

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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