UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053431 |
|---|---|
| Receipt number | R000060978 |
| Scientific Title | Effects of ultra-fine bubble water on suppressing oral malodor and improving oral environment |
| Date of disclosure of the study information | 2024/01/25 |
| Last modified on | 2024/01/24 18:54:35 |
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Basic information
Public title
Effects of ultra-fine bubble water on suppressing oral malodor and improving oral environment
Acronym
Effects of ultra-fine bubble water on oral health
Scientific Title
Effects of ultra-fine bubble water on suppressing oral malodor and improving oral environment
Scientific Title:Acronym
Effects of ultra-fine bubble water on oral health
Region
| Japan |
Condition
Condition
oral malodor
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Removal of bacteria and contaminants from the tongue and oral cavity is effective in suppressing bad breath and improving the oral environment. Using disinfectants and antibacterial agents reduces the number of bacteria in the oral cavity and temporarily reduces bad breath, but if they are used over a long period of time, there is a risk of bacterial replacement and the emergence of resistant bacteria. In this study, we decided to investigate the effects of suppressing bad breath and improving the oral environment using ultra-fine bubble water as a new method that is safe to use.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison of changes in concentration of volatile sulfur compounds before and after mouth rinsing with ultra-fine bubble water and tap water.
Key secondary outcomes
Comparison of changes in the components and bacteria in the rinse solution before and after mouth rinsing with ultra-fine bubble water and tap water
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Cluster
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
ultra-fine bubble water
Interventions/Control_2
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
| 18 | years-old | <= |
Age-upper limit
| 22 | years-old | > |
Gender
Female
Key inclusion criteria
Female university students with a healthy oral environment
Key exclusion criteria
People with caries or periodontal disease
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Masahiro |
| Middle name | |
| Last name | Yoneda |
Organization
Fukuoka Dental College
Division name
Department of General Dentistry
Zip code
814-0193
Address
2-15-1 Tamura Sawara-ku, Fukuoka
TEL
+81-092-801-0425
yoneda@fdcnet.ac.jp
Public contact
Name of contact person
| 1st name | Nao |
| Middle name | |
| Last name | Taniguchi |
Organization
Fukuoka Dental College
Division name
Department of Preventive and Public Health Dentistry
Zip code
814-0193
Address
2-15-1 Tamura Sawara-ku, Fukuoka
TEL
+81-092-801-0616
Homepage URL
naojsz@fdcnet.ac.jp
Sponsor or person
Institute
Fukuoka Dental College
Institute
Department
Personal name
Funding Source
Organization
Fukuoka Dental College
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
the Ethics Committee for Clinical Research of Fukuoka Gakuen
Address
2-15-1 Tamura Sawara-ku, Fukuoka
Tel
+81-092-801-0425
shomu@fdcnet.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
| 2024 | Year | 01 | Month | 25 | 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
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 11 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 11 | Month | 21 | Day |
Anticipated trial start date
| 2023 | Year | 12 | Month | 10 | 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
| 2024 | Year | 01 | Month | 24 | Day |
Last modified on
| 2024 | Year | 01 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060978
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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