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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000041713
Receipt No. R000047615
Scientific Title Effect of periodontitis by using toothpaste containing Kiso cypress water : single blinded study
Date of disclosure of the study information 2020/09/09
Last modified on 2020/09/07

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Basic information
Public title Effect of periodontitis by using toothpaste containing Kiso cypress water
Acronym Cypress toothpaste trial
Scientific Title Effect of periodontitis by using toothpaste containing Kiso cypress water : single blinded study
Scientific Title:Acronym Effect of periodontitis by using toothpaste containing Kiso cypress water
Region
Japan

Condition
Condition Healthy adult
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the effect of periodontal disease symptoms when brushing teeth for 4 weeks using test products
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Dentist evaluation, Number of Porphyromonas gingivalis
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 Brush teeth with a test article for 4 weeks
Interventions/Control_2 Brush teeth for 4 weeks without using toothpaste
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
40 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1. Subjects who have bleeding when brushing teeth
2. Subjects who are worried about bad breath from a third party
3. Subjects who feel stickiness in their mouth when waking up
Key exclusion criteria 1.Pregnant women/lactating
2. Subjects who are currently going to the hospital or receiving a prescription from a doctor
3.For full dentures
4. People who smoke
Target sample size 36

Research contact person
Name of lead principal investigator
1st name Masatomo
Middle name
Last name Najima
Organization Japan Clinical Trial Association
Division name N.A.
Zip code 1600022
Address 5F, 4-3-17 Shinjuku, Shinjukuku, Tokyo
TEL 0364574666
Email info@yakujihou.org

Public contact
Name of contact person
1st name Takeshi
Middle name
Last name Kaneko
Organization Japan Clinical Trial Association
Division name N.A.
Zip code 1600022
Address 5F, 4-3-17 Shinjuku, Shinjukuku, Tokyo
TEL 0364574666
Homepage URL
Email info@yakujihou.org

Sponsor
Institute Japan Clinical Trial Association
Institute
Department

Funding Source
Organization KISOHINOKI SANBYAKUNEN Co,.LTD.
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 Institutional Review Board of Pharmaceutical Law Wisdoms
Address 5F, 4-3-17 Shinjuku, Shinjukuku, Tokyo
Tel 0364574911
Email master@yakujihou.net

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

Other administrative information
Date of disclosure of the study information
2020 Year 09 Month 09 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
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 Preinitiation
Date of protocol fixation
2020 Year 07 Month 31 Day
Date of IRB
2020 Year 08 Month 20 Day
Anticipated trial start date
2020 Year 09 Month 09 Day
Last follow-up date
2020 Year 10 Month 07 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 09 Month 07 Day
Last modified on
2020 Year 09 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047615

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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