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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Preinitiation |
Unique ID issued by UMIN | UMIN000042582 |
Receipt No. | R000047742 |
Scientific Title | Examination of comfort quantification of cylindrical toothbrush using electroencephalogram and electrocardiogram measurement |
Date of disclosure of the study information | 2020/11/27 |
Last modified on | 2020/11/27 |
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 |
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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 |
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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 |
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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. | |
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Eligibility | ||||
Age-lower limit |
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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 |
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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 | ||||||
ito.ocsh@tmd.ac.jp |
Public contact | |||||||
Name of contact person |
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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 | |||||||
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 |
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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 |
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 |
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Date of disclosure of the study information |
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Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
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Baseline Characteristics | |
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Progress | |||||||
Recruitment status | Preinitiation | ||||||
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Last modified on |
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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 |