UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042356 |
|---|---|
| Receipt number | R000046946 |
| Scientific Title | A study on the effects of professional oral hygiene management for carriers of resistant bacteria |
| Date of disclosure of the study information | 2020/11/05 |
| Last modified on | 2024/11/08 08:39:46 |
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Basic information
Public title
A study on the effects of professional oral hygiene management for carriers of resistant bacteria
Acronym
A study on the effects of professional oral hygiene management for carriers of resistant bacteria
Scientific Title
A study on the effects of professional oral hygiene management for carriers of resistant bacteria
Scientific Title:Acronym
A study on the effects of professional oral hygiene management for carriers of resistant bacteria
Region
| Japan |
Condition
Condition
Dysphagia
Carrier of drug-resistant bacteria
Classification by specialty
| Pneumology | Infectious disease | Geriatrics |
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to confirm the change of the identified bacterial species and the disappearance/increase/decrease of the retained resistant bacteria by carrying out specialized oral hygiene management for the oral resistant bacteria carriers.
In addition, over the 1 year after the intervention, we investigate the presence or absence of pneumonia, the number of days until the onset of the first pneumonia, the severity at the time of the onset, and the treatment categories for medical/nursing care related pneumonia, and clinical studies on pneumonia in carriers of oral resistant bacteria.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Carrier investigation of target drug-resistant bacteria (ESBL- producing bacteria, carbapenem- resistant bacteria, MRSA) and Candida in 1-2 weeks, 6 months, and 1 year after the end of professional oral hygiene management.
Key secondary outcomes
Number of days until pneumonia onset after intervention, number of pneumonia episodes, severity of each pneumonia episode, medical/nursing care related pneumonia treatment category.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
In addition to daily oral cleaning, oral hygine management by dentists and dental hyginists.
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
1.the person with dysphagia
2.the person who can obtain written consent from the person concerned or his/her representative regarding participation in this study.
Key exclusion criteria
The person who the research director or co-investigators have deemed unsuitable
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Kazuhiro |
| Middle name | |
| Last name | Tsuga |
Organization
Graduate School of Biomedical and Health Sciences Hiroshima University
Division name
Department of Advanced Prosthodontics
Zip code
734-8553
Address
Kasumi 1-2-3, Minami-ku, Hiroshima
TEL
0822575677
tsuga@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Mineka |
| Middle name | |
| Last name | Yoshikawa |
Organization
Graduate School of Biomedical and Health Sciences Hiroshima University
Division name
Department of Advanced Prosthodontics
Zip code
734-8553
Address
Kasumi 1-2-3, Minami-ku, Hiroshima
TEL
0822575677
Homepage URL
mineka@hiroshima-u.ac.jp
Sponsor or person
Institute
Graduate School of Biomedical and Health Sciences Hiroshima University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Committee for Clinical Research of Hiroshima University
Address
Kasumi 1-2-3 Minami-ku, Hiroshima
Tel
0822571551
iryo-seisaku@office.hiroshima-u.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
| 2020 | Year | 11 | Month | 05 | 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
30
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
| 2020 | Year | 10 | Month | 30 | Day |
Date of IRB
| 2020 | Year | 10 | Month | 30 | Day |
Anticipated trial start date
| 2020 | Year | 11 | Month | 05 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 11 | Month | 05 | Day |
Last modified on
| 2024 | Year | 11 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046946
