UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of ultrasound toothbrushes on oral hygiene status
Title of the study (Brief title)	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	Akane Takenouchi
Organization	Taiyo School of Dental Hygiene
Division name	day-time class
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	Akane Takenouchi
Organization	Taiyo School of Dental Hygiene
Division name	day-time class
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)

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

Progress
Recruitment status	Main results already published
Date of protocol fixation	2017 Year 04 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000030827