UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002648 |
|---|---|
| Receipt number | R000003227 |
| Scientific Title | Effectiveness of the continuous professional oral health care in close community-cooperation for patients with cerebral vascular disorder |
| Date of disclosure of the study information | 2009/11/01 |
| Last modified on | 2017/03/31 16:21:00 |
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Basic information
Public title
Effectiveness of the continuous professional oral health care in close community-cooperation for patients with cerebral vascular disorder
Acronym
Effectiveness of the continuous professional oral health care
Scientific Title
Effectiveness of the continuous professional oral health care in close community-cooperation for patients with cerebral vascular disorder
Scientific Title:Acronym
Effectiveness of the continuous professional oral health care
Region
| Japan |
Condition
Condition
cerebral vascular disorder
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigation of the improvement of quality of life by the continuous professional oral health care in close community-cooperation for patients with cerebral vascular disorder
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Improvement of quality of life
Key secondary outcomes
Improvement of oral hygiene condition and oral function
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Continuous professional oral health care from acute period
Interventions/Control_2
Continuous professional oral health care from convalescence
Interventions/Control_3
Control
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients treated with professional oral health care at stroke care unit in Tokushima University Hospital
Key exclusion criteria
Patients with severe infectious disease
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Daisuke Hinode |
Organization
Institute of Health Biosciences,
The University of Tokushima Graduate School
Division name
Department of Hygiene and Oral Health Science
Zip code
Address
18-15 Kuramotocho 3-chome, Tokushima city
TEL
088-633-7543
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Daisuke Hinode |
Organization
Institute of Health Biosciences,The University of Tokushima Graduate School
Division name
Department of Hygiene and Oral Health Science
Zip code
Address
18-15 Kuramotocho 3-chome, Tokushima city
TEL
Homepage URL
Sponsor or person
Institute
Institute of Health Biosciences,
The University of Tokushima Graduate School
Institute
Department
Personal name
Funding Source
Organization
Grants-in-Aid for Scientific Research
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
| 2009 | Year | 11 | 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
| 2009 | Year | 11 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2016 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2009 | Year | 10 | Month | 19 | Day |
Last modified on
| 2017 | Year | 03 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003227
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
