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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

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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
Email 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
Email 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
Email 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
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


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