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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000032902
Receipt No. R000037516
Scientific Title Study on improvement effect of new oral care device on gingivitis
Date of disclosure of the study information 2018/10/01
Last modified on 2018/12/07

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Basic information
Public title Study on improvement effect of new oral care device on gingivitis
Acronym Verification of effect of new oral care device
Scientific Title Study on improvement effect of new oral care device on gingivitis
Scientific Title:Acronym 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
1st name
Middle name
Last name Sumio Akifusa
Organization Kyushu Dental University
Division name School of Oral Health Sciences
Zip code
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
1st name
Middle name
Last name Sumio Akifusa
Organization Kyushu Dental University
Division name School of Oral Health Sciences
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2018 Year 08 Month 01 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000037516

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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