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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000028532
Receipt No. R000032655
Scientific Title A study on effect of professional instruction for efficiency to remove dental plaque on patients first using an electric toothbrush
Date of disclosure of the study information 2017/08/04
Last modified on 2019/08/06

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Basic information
Public title A study on effect of professional instruction for efficiency to remove dental plaque on patients first using an electric toothbrush
Acronym Effect of professional instruction for patients first using an electric toothbrush
Scientific Title A study on effect of professional instruction for efficiency to remove dental plaque on patients first using an electric toothbrush
Scientific Title:Acronym Effect of professional instruction for patients first using an electric toothbrush
Region
Japan

Condition
Condition Periodontitis, gingivitis
Classification by specialty
Dental medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To verify the efficacy of professional instructions for removing dental plaque on the patient using an electric toothbrush for the first time.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Plaque Index after two weeks using an electrical toothbrush
Key secondary outcomes Gingival Index after two weeks using an electrical toothbrush

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Other
Interventions/Control_1 Receive professional instruction before using an electric toothbrush
Interventions/Control_2 Use an electric toothbrush without professional instruction
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

Not applicable
Gender Male and Female
Key inclusion criteria Volunteer who has never used an electric toothbrush and has target teeth, and no prosthetic for them.
Subjects with probing depth <= 4 mm
Key exclusion criteria Dentistry worker
Subjects who are treated for periodontal disease within three months
Target sample size 60

Research contact person
Name of lead principal investigator
1st name Takahiko
Middle name
Last name Morotomi
Organization Kyushu Dental University
Division name Division of Endodontics and Restorative Dentistry
Zip code 803-8580
Address 2-6-1 Manazuru, Kokurakita-ku, Kitakyushu 803-8580 Japan
TEL +81-93-582-1131
Email r13morotomi@fa.kyu-dent.ac.jp

Public contact
Name of contact person
1st name Takahiko
Middle name
Last name Morotomi
Organization Kyushu Dental University
Division name Division of Endodontics and Restorative Dentistry
Zip code 803-8580
Address 2-6-1 Manazuru, Kokurakita-ku, Kitakyushu 803-8580 Japan
TEL +81-93-582-1131
Homepage URL
Email r13morotomi@fa.kyu-dent.ac.jp

Sponsor
Institute Kyushu Dental University
Institute
Department

Funding Source
Organization Kyushu Dental University
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Tokuyama dental Corp.
Name of secondary funder(s)

IRB Contact (For public release)
Organization Kyushu Dental Univercity
Address 2-6-1 Manazuru, Kokurakita-ku, Kitakyushu City.
Tel 093-582-1131
Email r13morotomi@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 九州歯科大学附属病院

Other administrative information
Date of disclosure of the study information
2017 Year 08 Month 04 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 Preinitiation
Date of protocol fixation
2017 Year 05 Month 31 Day
Date of IRB
Anticipated trial start date
2017 Year 08 Month 07 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 08 Month 04 Day
Last modified on
2019 Year 08 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032655

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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