UMIN-CTR Clinical Trial

Basic information
Public title	A study on cleaning effect of toothbrush containing black silica + MISWAK powder
Acronym	A study of effect of new toothbrush
Scientific Title	A study on cleaning effect of toothbrush containing black silica + MISWAK powder
Scientific Title:Acronym	A study of cleaning effect of newly developed toothbrush
Region	Japan

Condition
Condition	Poor oral cleaning
Classification by specialty	Dental medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Elucidation of plaque removal effect of toothbrush containing black silica + MISWAK powder
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Plaque control record
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Non-randomized
Randomization unit
Blinding	Single blind -participants are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Device,equipment
Interventions/Control_1	Toothbrushing with a toothbrush containing black silica + MISWAK powder
Interventions/Control_2	Toothbrushing with Black Silica + MISWAK powder-free toothbrush
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	20 years-old <=
Age-upper limit	65 years-old >=
Gender	Male and Female
Key inclusion criteria	Not suffering from periodontal disease No missing teeth Does not have significant dental malpractice No functional impairment of fingers Right handed Non-Kanagawa Dental University students
Key exclusion criteria	Suffering from periodontal disease Have missing teeth There is a significant malpractice Functional impairment of fingers Left handed Kanagawa Dental University student
Target sample size	10

Research contact person
Name of lead principal investigator	1st name Keiichi Middle name Last name Tsukinoki
Organization	Kanagawa Dental University, Graduate School of Dentistry
Division name	Department of Oral Science
Zip code	2388580
Address	82 Inaoka, Yokosuka, Kanagawa 2388580, Japan
TEL	81-46-822-8866
Email	tsukinoki@kdu.ac.jp

Public contact
Name of contact person	1st name Keiichi Middle name Last name Tsukinoki
Organization	Kanagawa Dental University, Graduate School of Dentistry
Division name	Department of Oral Science
Zip code	2388580
Address	82 Inaoka, Yokosuka, Kanagawa 2388580, Japan
TEL	81-46-822-8866
Homepage URL
Email	tsukinoki@kdu.ac.jp

Sponsor
Institute	Kanagawa Dental University
Institute
Department

Funding Source
Organization	SHINYEI KAISHA
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Kanagawa Dental University
Address	82 Inaoka, Yokosuka, Kanagawa 2388580, Japan
Tel	0468228755
Email	graduate@kdu.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

Other administrative information
Date of disclosure of the study information	2020 Year 08 Month 15 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	2020 Year 07 Month 26 Day
Date of IRB	2020 Year 07 Month 30 Day
Anticipated trial start date	2020 Year 08 Month 15 Day
Last follow-up date	2020 Year 10 Month 30 Day
Date of closure to data entry	2020 Year 10 Month 30 Day
Date trial data considered complete	2020 Year 11 Month 01 Day
Date analysis concluded	2020 Year 12 Month 25 Day

Other
Other related information

Management information
Registered date	2020 Year 07 Month 26 Day
Last modified on	2021 Year 01 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000047065