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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000024272
Receipt No. R000027774
Scientific Title The effectiveness to prevent periodontitis brushing by roller-type toothbrush
Date of disclosure of the study information 2016/10/15
Last modified on 2016/10/03

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Basic information
Public title The effectiveness to prevent periodontitis brushing by roller-type toothbrush
Acronym The effectiveness to prevent periodontitis brushing by roller-type toothbrush
Scientific Title The effectiveness to prevent periodontitis brushing by roller-type toothbrush
Scientific Title:Acronym The effectiveness to prevent periodontitis brushing by roller-type toothbrush
Region
Japan

Condition
Condition periodontitis
Classification by specialty
Dental medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To exam the plaque removal rate brushing by roller-type toothbrush
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes plaque control record and plaque index
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -investigator(s) and assessor(s) 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 no brushing for twenty-four hours
Interventions/Control_2 no brushing for twenty-four hours
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
25 years-old <=
Age-upper limit
65 years-old >=
Gender Male and Female
Key inclusion criteria 30 volunteers(male and female) who belong to Tokyo Medical and Dental University, have test teeth, don't have prothesis for test teeth
Key exclusion criteria The man who don't agree with participate in study, don't have test teeth and don't have prosthesis for test teeth
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yuchi Izumi
Organization Tokyo Medical and Dental University
Division name Periodontology
Zip code
Address 1-5-45, Yushima, Bunkyoku, Tokyo
TEL 03-5803-5488
Email y-izumi.peri@tmd.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yuchi Izumi
Organization Tokyo Medical and Dental University
Division name Periodontology
Zip code
Address 1-5-45, Yushima, Bunkyoku, Tokyo
TEL 03-5803-5488
Homepage URL
Email y-izumi.peri@tmd.ac.jp

Sponsor
Institute Tokyo Medical and Dental University
Institute
Department

Funding Source
Organization Tokyo Medical and Dental University
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2016 Year 10 Month 15 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
2016 Year 08 Month 22 Day
Date of IRB
Anticipated trial start date
2016 Year 10 Month 15 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 10 Month 03 Day
Last modified on
2016 Year 10 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027774

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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