UMIN-CTR Clinical Trial

Basic information
Public title	Verification of comfort of cylindrical toothbrush by electroencephalogram and electrocardiogram measurement
Acronym	Cylindrical toothbrush comfort test
Scientific Title	Examination of comfort quantification of cylindrical toothbrush using electroencephalogram and electrocardiogram measurement
Scientific Title:Acronym	Comfort test of cylindrical toothbrush using electroencephalogram and electrocardiogram measurement
Region	Japan

Condition
Condition	People who are healthy, have no major scars or pain in the oral cavity, and do not interfere with daily oral care.
Classification by specialty	Dental medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	There is a cylindrical toothbrush as an oral cleaning tool that has good cleaning efficiency and feels comfortable. A cylindrical toothbrush is a toothbrush with soft bristles planted at 360 degrees, and its cleaning efficiency has been proven in both artificial plaque and human intervention studies. In particular, as a feeling of use as compared with other products, there is a tendency that "easiness to remove plaque" is good and "pain during use" is small. In addition, there is a report that the refusal is alleviated by pursuing "comfort" for elderly people with dementia who refuse to take oral care. If both comfort and cleaning efficiency can be achieved by using a cylindrical toothbrush, it is considered to be very meaningful for oral care with people who cannot express their feelings like elderly people with dementia. However, "comfort" in a cylindrical toothbrush is limited to measurement by a subjective index and has not been evaluated objectively. Therefore, the purpose of this study is to evaluate the "comfort" when brushing with a cylindrical toothbrush by measuring electroencephalogram and electrocardiogram objectively.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	EEG and electrocardiogram values during brushing
Key secondary outcomes	Visual Analogue Scale during brushing Plaque control record before and after brushing (plaque removal rate)

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	Self-tooth brushing with a cylindrical toothbrush, comparative toothbrush 1 (the toothbrush that the subject always uses) and comparative toothbrush 2 (standard type of the same standard) performed on the same day and all required time is about 20 minutes in total. Measure EEG / ECG while brushing their teeth.
Interventions/Control_2
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	23 years-old >=
Gender	Male and Female
Key inclusion criteria	Students belonging to the Department of Oral Health, Faculty of Dentistry, Tokyo Medical and Dental University.
Key exclusion criteria	When there is a severe wound in the oral cavity, which is accompanied by a wound or pain and interferes with daily oral cleaning.
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Kanade Middle name Last name Ito
Organization	Tokyo Medical and Dental University
Division name	Department of Oral Care for Systemic Health Support
Zip code	1138510
Address	1-5-45 Yushima, Bunkyo-ku, Tokyo 113-8510, Japan
TEL	+81-3-5803-4969
Email	ito.ocsh@tmd.ac.jp

Public contact
Name of contact person	1st name Kanade Middle name Ito Last name Ito
Organization	Tokyo Medical and Dental University
Division name	Department of Oral Care for Systemic Health Support
Zip code	1138510
Address	1-5-45 Yushima, Bunkyo-ku, Tokyo 113-8510, Japan
TEL	+81-3-5803-4969
Homepage URL
Email	ito.ocsh@tmd.ac.jp

Sponsor
Institute	Tokyo Medical and Dental University
Institute
Department

Funding Source
Organization	None
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	Tokyo Medical and Dental University School of Dentistry Ethics Review Committee
Address	1-5-45 Yushima, Bunkyo-ku, Tokyo 113-8510, Japan
Tel	+81-5803-5404
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	2020 Year 11 Month 27 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 09 Month 30 Day
Date of IRB
Anticipated trial start date	2021 Year 02 Month 01 Day
Last follow-up date	2023 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	2020 Year 11 Month 27 Day
Last modified on	2020 Year 11 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047742

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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