UMIN-CTR Clinical Trial

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

Contact us.