UMIN-CTR Clinical Trial

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

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

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

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)

Study type

Interventional

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

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

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

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

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

Institute

Tokyo Medical and Dental University

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

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

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2020

Year

11

Month

27

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2020

Year

11

Month

27

Day

Last modified on

2020

Year

11

Month

27

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047742