UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033699 |
|---|---|
| Receipt number | 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 10:27:42 |
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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
| Japan |
Condition
Condition
gingivitis
Classification by specialty
| Dental medicine |
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
| Device,equipment |
Interventions/Control_1
one week use of new electric toothbrush with monitor
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
| 18 | years-old | <= |
Age-upper limit
| 30 | years-old | >= |
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
| 1st name | Sumio |
| Middle name | |
| Last name | Akifusa |
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
| 1st name | Sumio |
| Middle name | |
| Last name | Akifusa |
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 or person
Institute
Kyushu Dental University
Institute
Department
Personal name
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
| 2019 | Year | 12 | Month | 03 | Day |
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
Results date posted
| 2019 | Year | 12 | Month | 03 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
undergraduate student
Participant flow
volunteer
Adverse events
No
Outcome measures
PHP
GI
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 08 | Month | 09 | Day |
Date of IRB
| 2018 | Year | 08 | Month | 28 | Day |
Anticipated trial start date
| 2018 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 10 | Month | 01 | Day |
Date of closure to data entry
| 2018 | Year | 10 | Month | 10 | Day |
Date trial data considered complete
| 2018 | Year | 10 | Month | 17 | Day |
Date analysis concluded
| 2019 | Year | 11 | Month | 25 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 08 | Month | 09 | Day |
Last modified on
| 2019 | Year | 12 | Month | 03 | Day |
Link to view the page
Value
https://center6.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 |
