UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039158 |
|---|---|
| Receipt number | R000044662 |
| Scientific Title | Study on relationship between periodontal pathogen and aspiration pneumonitis |
| Date of disclosure of the study information | 2021/12/31 |
| Last modified on | 2023/01/17 09:07:20 |
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Basic information
Public title
Study on relationship between periodontal pathogen and aspiration pneumonitis
Acronym
Study on relationship between periodontal pathogen and aspiration pneumonitis
Scientific Title
Study on relationship between periodontal pathogen and aspiration pneumonitis
Scientific Title:Acronym
Study on relationship between periodontal pathogen and aspiration pneumonitis
Region
| Japan |
Condition
Condition
Aspiration pneumonitis
periodontitis
Classification by specialty
| Pneumology | Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate relationship between onset of aspiration pnemonitis and periodontal pathogen in older residents of nursing homes.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
onset of aspiration pneumonia during study period
Key secondary outcomes
correlation between number of periodontal pathogens and onset of aspiration pnemonitis
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Persons who can get informed consent
Key exclusion criteria
leaving nursing home
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Ayaka |
| Middle name | |
| Last name | Isobe |
Organization
Kyushu Dental University
Division name
Department of support for senior citizens
Zip code
803-8580
Address
2-6-1, Manazuru, Kokurakita-ku, Kitakyushu
TEL
093-285-3107
r17isobe@fa.kyu-dent.ac.jp
Public contact
Name of contact person
| 1st name | Ayaka |
| Middle name | |
| Last name | Isobe |
Organization
Kyushu Dental University
Division name
Department of support for senior citizens
Zip code
803-8580
Address
2-6-1, Manazuru, Kokurakita-ku, Kitakyushu
TEL
093-285-3107
Homepage URL
r17isobe@fa.kyu-dent.ac.jp
Sponsor or person
Institute
Kyushu Dental University
Institute
Department
Personal name
Funding Source
Organization
Uchiyama holdings
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical review board of Kyushu Dental University
Address
2-6-1, Manazuru, Kokurakita-ku, Kitakyushu
Tel
093-582-1131
gakusei@kyu-dent.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 | 12 | Month | 31 | Day |
Related information
URL releasing protocol
unpublished
Publication of results
Unpublished
Result
URL related to results and publications
unpublished
Number of participants that the trial has enrolled
100
Results
unpublished
Results date posted
| 2022 | Year | 01 | Month | 17 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
unpublished
Participant flow
unpublished
Adverse events
no
Outcome measures
unpublished
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 01 | Month | 12 | Day |
Anticipated trial start date
| 2019 | Year | 02 | Month | 19 | Day |
Last follow-up date
| 2025 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2021 | Year | 12 | Month | 31 | Day |
Other
Other related information
onset of pneumonitis and fever during study period
Management information
Registered date
| 2020 | Year | 01 | Month | 15 | Day |
Last modified on
| 2023 | Year | 01 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044662
