UMIN-CTR Clinical Trial

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000020081
Receipt No. 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 (Ver. 11)

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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
Email 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
Email myamaya@med.tohoku.ac.jp

Sponsor
Institute Tohoku University Graduate School of Medicine
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000023201