UMIN-CTR Clinical Trial

Basic information
Public title	The effect of toothpaste on dental plaque formation in humans _A pilot study
Acronym	The effect of toothpaste on dental plaque formation in humans _A pilot study
Scientific Title	The effect of toothpaste on dental plaque formation in humans _A pilot study
Scientific Title:Acronym	The effect of toothpaste on dental plaque formation in humans _A pilot study
Region	Japan

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

Objectives
Narrative objectives1	To evaluate the effect of toothpaste on dental plaque formation
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Dental plaque after the use with a test toothpaste
Key secondary outcomes	Dental plaque after the use with a test toothpaste

Base
Study type	Interventional

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

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	Toothbrushing with test toothpaste1 (twice a day) for 2 weeks->wash out for 1 week->Toothbrushing with placebo toothpaste (twice a day) for 2 weeks->wash out for 1 week->Toothbrushing with test toothpaste2 (twice a day) for 2 weeks->wash out for 1 week->Toothbrushing with test toothpaste3 (twice a day) for 2 weeks->wash out for 1 week->Toothbrushing with test toothpaste4 (twice a day) for 2 weeks
Interventions/Control_2	Toothbrushing with placebo toothpaste (twice a day) for 2 weeks->wash out for 1 week->Toothbrushing with test toothpaste1 (twice a day) for 2 weeks->wash out for 1 week->Toothbrushing with test toothpaste2 (twice a day) for 2 weeks->wash out for 1 week->Toothbrushing with test toothpaste3 (twice a day) for 2 weeks->wash out for 1 week->Toothbrushing with test toothpaste4 (twice a day) for 2 weeks
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	60 years-old >
Gender	Male and Female
Key inclusion criteria	1) Those who satisfy the entry criteria for this test in questionnaire survey at the time of subject requirement. 2) Healthy male and female who are 20 years old and more and less than 60 years old at the time of acquiring consent. 3) Those who can continuously use test toothpaste and participate in the test including oral examination.
Key exclusion criteria	1) Subjects who received treatment of dental caries or periodontal disease in dental clinic 2) Subjects with serious wound in the oral cavity 3) Subjects with acute inflammation of the gingiva 4) Subjects with tooth mobility 5) Severe periodontitis patients
Target sample size	16

Research contact person
Name of lead principal investigator	1st name Hidetake Middle name Last name Fujinaka
Organization	Kao Corporation
Division name	Personal Health Care Products Research
Zip code	131-8501
Address	2-1-3, Bunka Sumida-ku Tokyo, 131-8501, JAPAN
TEL	03-5630-9747
Email	fujinaka.hidetake@kao.com

Public contact
Name of contact person	1st name Kayo Middle name Last name Sato
Organization	Kao Corporation
Division name	Personal Health Care Products Research
Zip code	131-8501
Address	2-1-3, Bunka Sumida-ku Tokyo, 131-8501, JAPAN
TEL	03-5630-9747
Homepage URL
Email	satou.kayo2@kao.com

Sponsor
Institute	Kao Corporation
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	Human Research Ethics Committee, Kao Corporation
Address	2-1-3, Bunka Sumida-ku Tokyo, 131-8501, JAPAN
Tel	03-5630-9786
Email	uesaka.toshio@kao.com

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	花王株式会社（東京都）

Other administrative information
Date of disclosure of the study information	2019 Year 05 Month 01 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	16
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	2019 Year 05 Month 15 Day
Date of IRB	2019 Year 03 Month 29 Day
Anticipated trial start date	2019 Year 05 Month 15 Day
Last follow-up date	2019 Year 12 Month 02 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 02 Month 28 Day
Last modified on	2019 Year 12 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041054