UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020081 |
|---|---|
| Receipt number | R000023201 |
| Scientific Title | Study on the prevention of senile pneumonia by oral care |
| Date of disclosure of the study information | 2015/12/07 |
| Last modified on | 2020/06/14 11:01:46 |
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Basic information
Public title
Study on the prevention of senile pneumonia by oral care
Acronym
Oral care and prevention of senile pneumonia
Scientific Title
Study on the prevention of senile pneumonia by oral care
Scientific Title:Acronym
Oral care and prevention of senile pneumonia
Region
| Japan |
Condition
Condition
pneumonia
Classification by specialty
| Pneumology | Geriatrics | Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the preventive effects of oral care by dentists using tooth brushing on the prevention of pneumonia and fever in elderly bedridden persons.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Frequency of pneumonia
Key secondary outcomes
Frequency of fever, serum protein concentration, number of lymphocytes in the peripheral venous blood
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 65 | years-old | <= |
Age-upper limit
| 110 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Bedridden elderly persons who can not do oral care using tooth brushing.
Key exclusion criteria
Persons who do not give informed consent.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Mutsuo |
| Middle name | |
| Last name | Yamaya |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Advanced Preventive Medicine for Infectious Disease
Zip code
980-8575
Address
2-1 Seiryo-machi, Aoba-ku, Sendai, 980-8575 Japan
TEL
022-717-7184
myamaya@med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Mutsuo |
| Middle name | |
| Last name | Yamaya |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Advanced Preventive Medicine for Infectious Disease
Zip code
980-8575
Address
2-1 Seiryo-machi, Aoba-ku, Sendai, 980-8575 Japan
TEL
022-717-7184
Homepage URL
myamaya@med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Tohoku University Graduate School of Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Meguro Dental Clinic
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Marumori Royal Care Center
Address
9-2 Toriya Marumori-Machi, Igu-Gun Miyagi Prefercture, Japan
Tel
0224-73-1101
info@ims.gr.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
丸森ロイヤルケアセンター
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 12 | Month | 07 | Day |
Related information
URL releasing protocol
http://www.gerodontology.jp/
Publication of results
Published
Result
URL related to results and publications
http://www.gerodontology.jp/
Number of participants that the trial has enrolled
21
Results
The frequency of fever was reduced after oral care in bed-ridden patients.
Results date posted
| 2019 | Year | 06 | Month | 12 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Bedridden older adults who were staying in a nursing home.
Participant flow
The data of bedridden patients whose frequency of fever was observed for 6 months were analyzed.
Adverse events
No.
Outcome measures
Frequency of fever.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2015 | Year | 12 | Month | 05 | Day |
Date of IRB
| 2015 | Year | 11 | Month | 12 | Day |
Anticipated trial start date
| 2015 | Year | 12 | Month | 07 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 07 | Day |
Date of closure to data entry
| 2018 | Year | 12 | Month | 07 | Day |
Date trial data considered complete
| 2018 | Year | 12 | Month | 07 | Day |
Date analysis concluded
| 2019 | Year | 12 | Month | 10 | Day |
Other
Other related information
After finishing of this study, we will show the results.
Study design: Case control study
Subjects: Elderly persons visiting the institutions between December 7, 2015 and December 7, 2018, whose conditions are fit for the criteria.
Check points:
Frequency of fever, Frequency of pneumonia and the time to the first pneumonia, Cause of death
Serum concentrations of protein and albumin
Number of lymphocyte in the peripheral venous blood
Management information
Registered date
| 2015 | Year | 12 | Month | 05 | Day |
Last modified on
| 2020 | Year | 06 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023201
| 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 |
