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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000026863
Receipt No. R000030827
Scientific Title Effects of ultrasound toothbrushes on oral hygiene status
Date of disclosure of the study information 2017/04/05
Last modified on 2018/04/09

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Basic information
Public title Effects of ultrasound toothbrushes on oral hygiene status
Acronym Effects of ultrasound toothbrushes on oral hygiene status
Scientific Title Effects of ultrasound toothbrushes on oral hygiene status
Scientific Title:Acronym Effects of ultrasound toothbrushes on oral hygiene status
Region
Japan

Condition
Condition healthy subjects
Classification by specialty
Vascular surgery Dental medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Clarify the effects of ultrasound toothbrushes on oral hygiene status.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Oral hygiene status: Plaque index (PlI), Gingival index (GI), Saliva flow rate.
Key secondary outcomes Mental health (GHQ-30, POM2)


Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -investigator(s) and assessor(s) are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Prevention
Type of intervention
Behavior,custom Other
Interventions/Control_1 Group A: will use an examined toothbrush with power-off.
Interventions/Control_2 Group B: will use an examined toothbrush with ultrasound mood.
Interventions/Control_3 Group B: will receive professional oral prophylaxis and use an examined toothbrush with ultrasound mood.
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 Students who agree with this study.
Key exclusion criteria Those who would not agree with the study. And those who had seen a psychiatrist, have periodontitis or severe gingivitis (GI>2.0), have active dental caries, or use a powered-toothbrush currently.
Target sample size 45

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Akane Takenouchi
Organization Taiyo School of Dental Hygiene
Division name day-time class
Zip code
Address Station Plaza Tower 6F, 2-22-1, Nishi-Nippori, Arakawa-ku, Tokyo, Japan
TEL 03-5810-8020
Email lisa_serugio4@hotmail.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Akane Takenouchi
Organization Taiyo School of Dental Hygiene
Division name day-time class
Zip code
Address Station Plaza Tower 6F, 2-22-1, Nishi-Nippori, Arakawa-ku, Tokyo, Japan
TEL 03-5810-8020
Homepage URL
Email lisa_serugio4@hotmail.co.jp

Sponsor
Institute Taiyo School of Dental Hygiene

Institute
Department

Funding Source
Organization Taiyo School of Dental Hygiene
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor ITO CO.,LTD
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

Other administrative information
Date of disclosure of the study information
2017 Year 04 Month 05 Day

Related information
URL releasing protocol
Publication of results Published

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 Main results already published
Date of protocol fixation
2017 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2017 Year 04 Month 01 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 04 Month 05 Day
Last modified on
2018 Year 04 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030827

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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