UMIN-CTR Clinical Trial

Basic information
Public title	The brushing effect using the absorption toothbrush in oral cavity care
Acronym	The brushing effect using the absorption toothbrush in oral cavity care
Scientific Title	The brushing effect using the absorption toothbrush in oral cavity care
Scientific Title:Acronym	The brushing effect using the absorption toothbrush in oral cavity care
Region	Japan

Condition
Condition	Patients with intratracheal intubation
Classification by specialty	Intensive care medicine Nursing
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To make clear if the usage of the absorption toothbrushes can stop spraying plaque and bacteria in oral cavity care. Although this study cannot prove absolutely the protections of VAP or aspiration pneumonitis just because our subjects are healthy people, it can be made generally clear one of the interventions, aiming for the best practice in the way of the oral cavity care for the protection from VAP and aspiration pneumonitis during the acute medical care.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Intraoral bacterial count. Front and back of the mouth care,After brushing.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Cluster
Blinding	Open -but assessor(s) 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	Interventions1)brushing methods with absorbing the disposable absorption toothbrushes. Interventions2)brushing methods without absorbing the disposable absorption toothbrushes.
Interventions/Control_2	Interventions1)brushing methods without absorbing the disposable absorption toothbrushes. Interventions2)brushing methods with absorbing the disposable absorption toothbrushes.
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	30 years-old >
Gender	Male and Female
Key inclusion criteria	People in their twenties. Without regard to sex. Those who agreed with the explanations in this document concerning this study.
Key exclusion criteria	Those who in a dental hospital. Those who, getting the diagnosis of decayed teeth, leave to stand. Those who have one point in the gum items of the Eilers Oral Cavity Assessment Guide.
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Middle name Last name Asami Tado
Organization	Yamaguchi University Graduate School of Medicine
Division name	Faculty of Health Science
Zip code
Address	1-1-1 Minani Kogushi, Ube, Yamaguchi
TEL	0836-22-2842
Email	asamik@yamaguchi-u.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Asami Tado
Organization	Yamaguchi University Graduate School of Medicine
Division name	Faculty of Health Science
Zip code
Address	1-1-1 Minani Kogushi, Ube, Yamaguchi
TEL	0836-22-2842
Homepage URL
Email	asamik@yamaguchi-u.ac.jp

Sponsor
Institute	The field of clinical nursing
Institute
Department

Funding Source
Organization	Yamaguchi University Graduate School of Medicine
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

Other administrative information
Date of disclosure of the study information	2015 Year 10 Month 19 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	2015 Year 07 Month 02 Day
Date of IRB	2015 Year 10 Month 10 Day
Anticipated trial start date	2015 Year 10 Month 10 Day
Last follow-up date	2016 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2016 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date	2015 Year 10 Month 19 Day
Last modified on	2020 Year 09 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000022444