UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019405 |
|---|---|
| Receipt number | R000022444 |
| Scientific Title | The brushing effect using the absorption toothbrush in oral cavity care |
| Date of disclosure of the study information | 2015/10/19 |
| Last modified on | 2020/09/11 09:49:54 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
asamik@yamaguchi-u.ac.jp
Sponsor or person
Institute
The field of clinical nursing
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022444
