UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061206 |
|---|---|
| Receipt number | R000070036 |
| Scientific Title | A Comparative Study of the Effectiveness of Brushing and L8020 Application in Reducing Oral Bacterial Counts in Intubated Patients: A Preliminary Study |
| Date of disclosure of the study information | 2026/04/09 |
| Last modified on | 2026/04/09 06:36:58 |
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Basic information
Public title
A Comparative Study of the Effectiveness of Brushing and L8020 Application in Reducing Oral Bacterial Counts in Intubated Patients: A Preliminary Study
Acronym
A Comparative Study of the Effectiveness of Brushing and L8020 Application in Reducing Oral Bacterial Counts in Intubated Patients
Scientific Title
A Comparative Study of the Effectiveness of Brushing and L8020 Application in Reducing Oral Bacterial Counts in Intubated Patients: A Preliminary Study
Scientific Title:Acronym
A Comparative Study of the Effectiveness of Brushing and L8020 Application in Reducing Oral Bacterial Counts in Intubated Patients: A Preliminary Study
Region
| Japan |
Condition
Condition
Patients on endotracheal intubation
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study examines patients under endotracheal intubation to determine whether brushing or the application of L8020 mouthwash which has an inhibitory effect on periodontal and cariogenic bacteria is more effective at reducing bacterial counts in oropharyngeal fluid.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Phase II
Assessment
Primary outcomes
oral bacterial count
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
After performing oral care, apply L8020.
Interventions/Control_2
After performing oral care, apply tap water.
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
| 45 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients in the ICU who are intubated due to cerebrovascular disease, cardiovascular disease, or severe infection.
2. Patients aged 45 years or older
3. Patients for whom consent has been obtained from the patient, their family, or a surrogate decision-maker after receiving a thorough explanation and demonstrating a full understanding of the study (since the patient is intubated and consent cannot be obtained prior to intubation).
Key exclusion criteria
1. Patients with conditions other than the target disease.
2. Patients with edentulism.
3. Patients who do not consent to participate in the study.
4. Any other patients deemed unsuitable for the study by the principal investigator or other study personnel.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Tomofumi |
| Middle name | |
| Last name | Naruse |
Organization
Hiroshima Prefectural Hospital
Division name
Dentistry and Oral Surgery
Zip code
734-8530
Address
5-54 Ujina-Kanda 1-chome, Minami Ward, Hiroshima City
TEL
0822541818
natsuaya1023@gmail.com
Public contact
Name of contact person
| 1st name | Tomofumi |
| Middle name | |
| Last name | Naruse |
Organization
Hiroshima Prefectural Hospital
Division name
Dentistry and Oral Surgery
Zip code
734-8530
Address
5-54 Ujina-Kanda 1-chome, Minami Ward, Hiroshima City
TEL
0822541818
Homepage URL
natsuaya1023@gmail.com
Sponsor or person
Institute
others
Institute
Department
Personal name
Funding Source
Organization
others
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
Hiroshima prefectural hospital
Address
5-54 Ujina-Kanda 1-chome, Minami Ward, Hiroshima City
Tel
0822541818
natsuaya1023@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
| 2026 | Year | 04 | Month | 09 | 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
Open public recruiting
Date of protocol fixation
| 2026 | Year | 03 | Month | 31 | Day |
Date of IRB
| 2026 | Year | 03 | Month | 09 | Day |
Anticipated trial start date
| 2026 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2026 | 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
| 2026 | Year | 04 | Month | 09 | Day |
Last modified on
| 2026 | Year | 04 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070036
