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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000033880
Receipt No. R000038641
Scientific Title Effects of ultrasound of sonic toothbrush on oral hygiene
Date of disclosure of the study information 2018/11/01
Last modified on 2019/08/26

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Basic information
Public title Effects of ultrasound of sonic toothbrush on oral hygiene
Acronym Effects of ultrasound of sonic toothbrush on oral hygiene
Scientific Title Effects of ultrasound of sonic toothbrush on oral hygiene
Scientific Title:Acronym Effects of ultrasound of sonic toothbrush on oral hygiene
Region
Japan Africa

Condition
Condition healthy subjects
Classification by specialty
Endocrine surgery Blood transfusion Dental medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Identify the effects of ultrasound on sonic toothbrush by dividing participants into two groups. Participants in test group will use sonic toothbrush with ultrasound, and those in control group will use sonic toothbrush without ultrasound.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Oral hygiene: Plaque index (PlI), Gingival index (GI), Saliva flow rates, tongue coating, halitosis
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Behavior,custom Other
Interventions/Control_1 Group A will use sonic toothbrush which emits ultrasound.
Interventions/Control_2 Group B will use sonic toothbrush which does not emit ultrasound.
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
74 years-old >=
Gender Male and Female
Key inclusion criteria Patients receiving a regularly check-up.
Key exclusion criteria Those who would not agree with the study. And those who are using powered toothbrushes, use a pace-maker, take antibiotics, antiphlogistics, or other dental treatments will be excluded.
Target sample size 34

Research contact person
Name of lead principal investigator
1st name Atsuhiro
Middle name
Last name Kinoshita
Organization Tokyo Medical and Dental University (TMDU)
Division name Department of Educational Media Development
Zip code 113-8510
Address 1-5-45 Yushima, Bunkyo-ku, Tokyo, Japan
TEL 03-5803-4643
Email kinoshita.emdv@tmd.ac.jp

Public contact
Name of contact person
1st name Akane
Middle name
Last name Takenouchi
Organization Tokyo Medical and Dental University (TMDU)
Division name Department of Educational Media Development
Zip code 113-8510
Address 1-5-45 Yushima, Bunkyo-ku, Tokyo, Japan
TEL 03-5803-4643
Homepage URL
Email akane.emdv@tmd.ac.jp

Sponsor
Institute Tokyo Medical and Dental University
Institute
Department

Funding Source
Organization ITO Company.,LTD
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 Tokyo Medical and Dental University
Address 1-5-45 Yushima, Bunkyo-ku, Tokyo, Japan
Tel 0358035404
Email d-hyoka.adm@tmd.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

Other administrative information
Date of disclosure of the study information
2018 Year 11 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
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
2018 Year 08 Month 23 Day
Date of IRB
2018 Year 11 Month 26 Day
Anticipated trial start date
2018 Year 11 Month 01 Day
Last follow-up date
2024 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 08 Month 24 Day
Last modified on
2019 Year 08 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038641

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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