UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009254 |
|---|---|
| Receipt number | R000010831 |
| Scientific Title | Oral care: efficasy of electric toothbrush |
| Date of disclosure of the study information | 2012/12/01 |
| Last modified on | 2013/10/15 13:03:32 |
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Basic information
Public title
Oral care: efficasy of electric toothbrush
Acronym
Oral care: efficasy of electric toothbrush
Scientific Title
Oral care: efficasy of electric toothbrush
Scientific Title:Acronym
Oral care: efficasy of electric toothbrush
Region
| Japan |
Condition
Condition
persons with disabilities
Classification by specialty
| Neurology | Dental medicine | Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate efficacy and safety of the oral care with electric toothbrush.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Oral state after one month
Key secondary outcomes
*number of bacteria in saliva
*occult blood in saliva
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
electric toothbrush
Interventions/Control_2
manual 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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
inability to brush tooth all alone
Key exclusion criteria
*no tooth
*instability of tooth
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tokuhei Ikeda |
Organization
National Hospital Organization Iou Hospital
Division name
Neurology
Zip code
Address
73-1, Iwade-machi, Kanazawa, Japan
TEL
076-258-1180
tokuhei@med.kanazawa-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tokuhei Ikeda |
Organization
National Hospital Organization Iou Hospital
Division name
Neurology
Zip code
Address
73-1, Iwade-machi, Kanazawa, Japan
TEL
076-258-1180
Homepage URL
tokuhei@med.kanazawa-u.ac.jp
Sponsor or person
Institute
Neurology of National Hospital Organization Iou Hospital
Institute
Department
Personal name
Funding Source
Organization
MHLW
Organization
Division
Category of Funding Organization
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
| 2012 | Year | 12 | Month | 01 | 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
| 2012 | Year | 09 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 11 | 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
| 2012 | Year | 11 | Month | 03 | Day |
Last modified on
| 2013 | Year | 10 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010831
