UMIN-CTR Clinical Trial

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
Email	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
Email	satoshi12212002@gmail.com

Sponsor
Institute	Saitama Medical University General Medical Center
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056409