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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000036042
Receipt No. R000041054
Scientific Title The effect of toothpaste on dental plaque formation in humans _A pilot study
Date of disclosure of the study information 2019/05/01
Last modified on 2019/05/09

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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 No longer recruiting
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 04 Month 24 Day
Last follow-up date
2019 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
2019 Year 02 Month 28 Day
Last modified on
2019 Year 05 Month 09 Day


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

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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