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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000044716
Receipt No. R000051071
Scientific Title A study to evaluate the effect of dentist intervention on prognosis in patients with aspiration pneumonia.
Date of disclosure of the study information 2021/06/30
Last modified on 2021/06/30

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Basic information
Public title A study to evaluate the effect of dentist intervention on prognosis in patients with aspiration pneumonia.
Acronym Study on the prognosis of aspiration pneumonia
Scientific Title A study to evaluate the effect of dentist intervention on prognosis in patients with aspiration pneumonia.
Scientific Title:Acronym Study on the prognosis of aspiration pneumonia
Region
Japan

Condition
Condition aspiration pneumonia
Classification by specialty
Medicine in general Geriatrics Dental medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To assess the prognosis of aspiration pneumonia with dentist intervention.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Evaluation of recurrence rate of aspiration pneumonia by dentist intervention
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Intervention Group: Oral care by a dentist. Once a week for a total of one month
Control Group: Oral care by nurses
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients who were admitted to Juntendo Koto Geriatric Medical Center and met the diagnostic criteria for aspiration pneumonia.
The criteria for aspiration pneumonia were fulfilled both 1)-3).
1) Radiological findings compatible with aspiration pneumonia on chest x-ray or CT.
2) Witnessing of aspiration by family members, caregivers, medical staff, or others, or factors suggestive of aspiration.
3) Acute respiratory symptoms suggestive of pneumonia (cough, sputum, fever, dyspnea).
Key exclusion criteria Exclusion criteria
(1) Patients admitted with aspiration pneumonia who do not meet the above diagnostic criteria
(2) Patients diagnosed with cancer, tuberculosis, or viral pneumonia
(3) Patients who were readmitted to the hospital, the data from the first hospitalization will be used to avoid duplication.
(4) Other patients who are judged by the principal investigator to be inappropriate as research subjects.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Miyagami
Middle name
Last name Taiju
Organization Juntendo University
Division name General medicine department
Zip code 113-8431
Address Tokyo-to Bunkyo-ku Hongo 3-1-3
TEL 0338133111
Email tmiyaga@juntendo.ac.jp

Public contact
Name of contact person
1st name Miyagami
Middle name
Last name Taiju
Organization Juntendo University
Division name General medicine department
Zip code 113-8431
Address Tokyo-to Bunkyo-ku Hongo 3-1-3
TEL 0338133111
Homepage URL
Email tmiyaga@juntendo.ac.jp

Sponsor
Institute Juntendo University
Institute
Department

Funding Source
Organization N/A
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Juntendo University
Address Tokyo-to Koto-ku Shinsuna 3-3-20
Tel 0356323111
Email kubota_kei@juntendo.gmc.ac.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

Other administrative information
Date of disclosure of the study information
2021 Year 06 Month 30 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 Enrolling by invitation
Date of protocol fixation
2021 Year 04 Month 01 Day
Date of IRB
2021 Year 02 Month 02 Day
Anticipated trial start date
2021 Year 04 Month 01 Day
Last follow-up date
2022 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2021 Year 06 Month 30 Day
Last modified on
2021 Year 06 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051071

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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