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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000033699 |
Receipt No. | R000038422 |
Scientific Title | Study on effect of new devise for oral care on dental plaque clearance |
Date of disclosure of the study information | 2019/12/03 |
Last modified on | 2019/12/03 |
Basic information | ||
Public title | Study on effect of new devise for oral care on dental plaque clearance | |
Acronym | Proving test of new device for oral care | |
Scientific Title | Study on effect of new devise for oral care on dental plaque clearance | |
Scientific Title:Acronym | Proving test of new device for oral care | |
Region |
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Condition | ||
Condition | gingivitis | |
Classification by specialty |
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Classification by malignancy | Others | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | An aim of this study is to investigate whether new device's function for visualization and digitization of dental plaque improve dental plaque clearance of self oral care and oral health behavior. |
Basic objectives2 | Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | Confirmatory |
Trial characteristics_2 | Pragmatic |
Developmental phase | Not applicable |
Assessment | |
Primary outcomes | after 1 week from strat intervention |
Key secondary outcomes |
Base | |
Study type | Interventional |
Study design | |
Basic design | Parallel |
Randomization | Randomized |
Randomization unit | Individual |
Blinding | Single blind -participants are blinded |
Control | Placebo |
Stratification | YES |
Dynamic allocation | NO |
Institution consideration | Institution is not considered as adjustment factor. |
Blocking | NO |
Concealment | No need to know |
Intervention | ||
No. of arms | 2 | |
Purpose of intervention | Treatment | |
Type of intervention |
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Interventions/Control_1 | one week use of new electric toothbrush with monitor
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Interventions/Control_2 | one week use of new electric toothbrush without monitor | |
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 |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | Normal subject without gingivitis | |||
Key exclusion criteria | Subjects who have injury of gingiva by new electronic toothbrush | |||
Target sample size | 20 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Kyushu Dental University | ||||||
Division name | School of Oral Health Sciences | ||||||
Zip code | 8038580 | ||||||
Address | 2-6-1, Manazuru, Kokurakita-ku, Kitakyushu, Fukuoka | ||||||
TEL | 093-285-3107 | ||||||
r11akifusa@fa.kyu-dent.ac.jp |
Public contact | |||||||
Name of contact person |
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Organization | Kyushu Dental University | ||||||
Division name | School of Oral Health Sciences | ||||||
Zip code | 8038580 | ||||||
Address | 2-6-1, Manazuru, Kokurakita-ku, Kitakyushu, Fukuoka | ||||||
TEL | 093-285-3107 | ||||||
Homepage URL | |||||||
r11akifusa@fa.kyu-dent.ac.jp |
Sponsor | |
Institute | Kyushu Dental University |
Institute | |
Department |
Funding Source | |
Organization | Kyushu Dental University |
Organization | |
Division | |
Category of Funding Organization | Other |
Nationality of Funding Organization |
Other related organizations | |
Co-sponsor | HA-PPY Co., Ltd |
Name of secondary funder(s) |
IRB Contact (For public release) | |
Organization | Kyushu Dental University |
Address | 2-6-1, Manazuru, Kokurakita-ku, Kitakyushu |
Tel | 0932853107 |
r11akifusa@fa.kyu-dent.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 | 九州歯科大学(福岡県) |
Other administrative information | |||||||
Date of disclosure of the study information |
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Related information | |
URL releasing protocol | no |
Publication of results | Published |
Result | |||||||
URL related to results and publications | no | ||||||
Number of participants that the trial has enrolled | 20 | ||||||
Results | Monitor usage group removed dental plaque more efficiency, comparing with monitor non-use group |
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Results date posted |
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Results Delayed | |||||||
Results Delay Reason | |||||||
Date of the first journal publication of results | |||||||
Baseline Characteristics | undergraduate student |
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Participant flow | volunteer |
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Adverse events | No |
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Outcome measures | PHP GI |
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Plan to share IPD | |||||||
IPD sharing Plan description |
Progress | |||||||
Recruitment status | Completed | ||||||
Date of protocol fixation |
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Date of IRB |
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Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry |
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Date trial data considered complete |
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Date analysis concluded |
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Other | |
Other related information |
Management information | |||||||
Registered date |
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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=R000038422 |
Research Plan | |
Registered date | File name |
2019/12/03 | 研究計画書.doc |
Research case data specifications | |
Registered date | File name |
2019/12/03 | 倫理申請書書.doc |
Research case data | |
Registered date | File name |
2019/12/03 | 名簿.xlsx |