UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036042 |
|---|---|
| Receipt number | 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 | 2019/12/03 17:24:20 |
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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
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
satou.kayo2@kao.com
Sponsor or person
Institute
Kao Corporation
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041054
