UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049541 |
|---|---|
| Receipt number | R000056409 |
| Scientific Title | Comparison of the amount of bacteria between oral brushing care and saliva secretion promotion care |
| Date of disclosure of the study information | 2022/12/01 |
| Last modified on | 2022/11/17 15:41:17 |
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Basic information
Public title
Comparison of the amount of bacteria between oral brushing care and saliva secretion promotion care
Acronym
Comparison of the amount of bacteria between oral brushing care and saliva secretion promotion care
Scientific Title
Comparison of the amount of bacteria between oral brushing care and saliva secretion promotion care
Scientific Title:Acronym
Comparison of the amount of bacteria between oral brushing care and saliva secretion promotion care
Region
| Japan |
Condition
Condition
Comparison of the amount of bacteria between oral brushing care and saliva secretion promotion care
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Comparison and clarification of the number of bacteria in oral care by brushing and oral care by promoting saliva secretion
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Gram-positive cocci
Key secondary outcomes
Gram-negative cocci, Gram-positive bacilli, Gram-negative bacilli, squamous epithelium, WBC
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
First day
Oral swab collection before brushing care
brushing care
Oral swab collection after brushing care
Interventions/Control_2
he 2nd day
Oral swab collection before salivary stimulation care
Salivation promotion care
Oral swab collection after salivary stimulation care
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
| Not applicable |
Age-upper limit
| 15 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with endotracheal intubation or tracheotomy who are hospitalized in the PICU
Key exclusion criteria
edentulous patient
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Satoshi Fujii |
| Middle name | |
| Last name | male |
Organization
Saitama Medical University General Medical Center
Division name
nursing department
Zip code
336-0936
Address
1-13-2 Daitakubo, Midori-ku, Saitama Ken
TEL
049-228-3864
satoshi12212002@gmail.com
Public contact
Name of contact person
| 1st name | Satoshi Fujii |
| Middle name | |
| Last name | male |
Organization
Saitama Medical University General Medical Center
Division name
nursing department
Zip code
336-0936
Address
1-13-2 Daitakubo, Midori-ku, Saitama Ken
TEL
080-5458-9266
Homepage URL
satoshi12212002@gmail.com
Sponsor or person
Institute
Saitama Medical University General Medical Center
Institute
Department
Personal name
Funding Source
Organization
Saitama Medical University General Medical Center
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Saitama Medical University General Medical Center
Address
1981 Kamoda, Kawagoe City, Saitama Prefecture
Tel
049-228-3864
satoshi12212002@gmail.com
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
| 2022 | Year | 12 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2022 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2022 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2024 | 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
| 2022 | Year | 11 | Month | 17 | Day |
Last modified on
| 2022 | Year | 11 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056409
