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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000028526
Receipt No. R000032647
Scientific Title Study on the effect of newly developed ionic oral cleaning tools
Date of disclosure of the study information 2017/08/03
Last modified on 2017/08/03

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Basic information
Public title Study on the effect of newly developed ionic oral cleaning tools
Acronym Study on the effect of newly developed ionic oral cleaning tools
Scientific Title Study on the effect of newly developed ionic oral cleaning tools
Scientific Title:Acronym Study on the effect of newly developed ionic oral cleaning tools
Region
Japan

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

Objectives
Narrative objectives1 A double-blind comparative control of a healthy subject and a patient suffering from periodontitis is performed on a newly developed ionic oral cleaning tools expected to reduce the adsorption power of the tooth surface of plaque by negative ions, the effect of removing the plus consider.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes PPD (Pocket Probing Depth), BOP (Bleeding On Probing), Rustogi Modification method of Navy Plaque Index, breath measurement, questionnaire
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Active
Stratification NO
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 ionic toothbrush
Interventions/Control_2 ionic electric toothbrush
Interventions/Control_3 toothbrush
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
90 years-old >=
Gender Male and Female
Key inclusion criteria There are more than 20 teeth left at present
Do not suffer from periodontal disease
Periodontal therapy is in the maintenance phase
Key exclusion criteria Those who did not agree to participate in the research
Person who is difficult to self-determination
There is no serious systemic illness
Not during pregnancy or lactation
Acute symptoms of periodontal disease are observed
Not taking antimicrobial medicine within 3 months
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Koji Mizutani
Organization Tokyo Medical and Dental University
Division name Periodontology
Zip code
Address 1-5-45 Yushima, Bunkyo-ku, Tokyo, 113-8510, Japan
TEL 03-5803-5488
Email mizuperi@tmd.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takeaki Sudo
Organization Tokyo Medical and Dental University
Division name Periodontology
Zip code
Address 1-5-45 Yushima, Bunkyo-ku, Tokyo, 113-8510, Japan
TEL 03-5803-5488
Homepage URL
Email t-sudo.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 Self funding
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 東京医科歯科大学歯学部附属病院

Other administrative information
Date of disclosure of the study information
2017 Year 08 Month 03 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
2017 Year 07 Month 30 Day
Date of IRB
Anticipated trial start date
2017 Year 10 Month 01 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
2017 Year 08 Month 03 Day
Last modified on
2017 Year 08 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032647

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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