Unique ID issued by UMIN | UMIN000021294 |
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Receipt number | R000024558 |
Scientific Title | Clinical trial of a new oral plaque removal device using the micro-scale mist |
Date of disclosure of the study information | 2016/03/02 |
Last modified on | 2016/08/19 21:28:17 |
Clinical trial of a new oral plaque removal device using the micro-scale mist
Oral plaque removal test by the micro-scale mist
Clinical trial of a new oral plaque removal device using the micro-scale mist
Oral plaque removal test by the micro-scale mist
Japan |
Oral hygiene failure
Dental medicine |
Others
NO
We comfirm the efficacy and safety of new oral plaque removal equipment by pain assessment and cleaning rate after mist injection into the maxillary central incisor both sides and to the palate, the tongue part.
Safety,Efficacy
Exploratory
Phase I
(1) cleaning rate after mist injection into the upper jaw on both sides central incisor (comparison of before and after treatment)
(2) assessment of pain immediately after and one day after the mist injection into the palate portion and the tongue
(3) assessment of inflammation immediately after and one day after the mist injection
into the palate portion and the tongue
(1) the treatment time of up to both sides maxillary central incisor of the plaque is completely removed
(2) adverse events and the failure
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Device,equipment |
The injection of the test equipment to the surface of maxillary central incisors sides,the palate portion and the tongue
20 | years-old | <= |
Not applicable |
Male and Female
men and women over 20 years of age at the time of obtaining informed consent
(1) a person who has a significant malocclusions and periodontal disease
(2) a person who has a tooth during treatment
(3) a person who has oral mucosal disease
(4) those with vomiting reflex
(5) Other, who one and principal investigator with systemic disease or research team members has judged it difficult to participate in test
10
1st name | |
Middle name | |
Last name | Keiichi Sasaki |
Tohoku University Graduate School of Dentistry
Advanced Prosthetic Dentistry
4-1 Seiryo-machi, Aoba-ku,Sendai,980-8575,Japan
022-717-8368
keii@dent.tohoku.ac.jp
1st name | |
Middle name | |
Last name | Takeshi Fuji |
Tohoku University Graduate School of Dentistry
Comprehensive Education Center for
4-1 Seiryo-machi, Aoba-ku,Sendai,980-8575,Japan
022-717-8369
f-takeshi@dent.tohoku.ac.jp
Tohoku University Graduate School of Dentistry
Japan Agency for Medical Research and Development
Other
NO
2016 | Year | 03 | Month | 02 | Day |
Unpublished
Completed
2016 | Year | 03 | Month | 02 | Day |
2016 | Year | 03 | Month | 02 | Day |
2016 | Year | 03 | Month | 02 | Day |
2016 | Year | 08 | Month | 19 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024558
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