UMIN-CTR Clinical Trial

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/icdr_e/ctr_view.cgi?recptno=R000038641