UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study on improvement effect of new oral care device on gingivitis
Title of the study (Brief title)	Verification of effect of new oral care device
Region	Japan

Condition
Condition	Gingivitis
Classification by specialty	Dental medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to evaluate effect of new electric tooth brush device with monitor for visualization and digitization of dental plaque on removing dental plaque in self oral care.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Gingival index at baseline,at 1 week after cessation of toothbrushing, and at additional 1 week after intervention
Key secondary outcomes	patient hygiene performance at baseline,at 1 week after cessation of toothbrushing, and at additional 1 week after intervention Questionnaire investigation on oral health before and after experiment ADCheck at baseline,at 1 week after cessation of toothbrushing, and at additional 1 week after intervention

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	NO
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	Duration of intervention: 1 week Frequency of intervention: 1 time
Interventions/Control_2	Duration of intervention: 1 week Frequency of intervention: 1 time
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	Healthy persons without gingivaitis
Key exclusion criteria	Person suffered from severe gingivitis for the duration of examination
Target sample size	20

Research contact person
Name of lead principal investigator	Sumio Akifusa
Organization	Kyushu Dental University
Division name	School of Oral Health Sciences
Address	2-6-1, Manazuru, Kokurakita, Kitakyush-shi
TEL	093-285-3107
Email	r11akifusa@fa.kyu-dent.ac.jp

Public contact
Name of contact person	Sumio Akifusa
Organization	Kyushu Dental University
Division name	School of Oral Health Sciences
Address	2-6-1, Manazuru, Kokurakita, Kitakyush-shi
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
Name of secondary funｄer(s)

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	2018 Year 10 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2018 Year 08 Month 01 Day
Anticipated trial start date	2018 Year 08 Month 08 Day
Last follow-up date	2018 Year 09 Month 30 Day
Date of closure to data entry	2019 Year 03 Month 31 Day
Date trial data considered complete	2019 Year 03 Month 31 Day
Date analysis concluded	2019 Year 03 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2018 Year 06 Month 07 Day
Last modified on	2018 Year 12 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000037516