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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000040628
Receipt No. R000044883
Scientific Title Study on plaque formation by using a dentifrice
Date of disclosure of the study information 2020/06/07
Last modified on 2020/06/02

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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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