UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042620 |
|---|---|
| Receipt number | R000048638 |
| Scientific Title | Effect of cleaning and gargle after brushing using the number of microorganisms in the oral cavity as an index |
| Date of disclosure of the study information | 2020/12/10 |
| Last modified on | 2022/01/21 08:52:58 |
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Basic information
Public title
Effect of cleaning and gargle after brushing using the number of microorganisms in the oral cavity as an index
Acronym
Effect of cleaning and gargle after brushing using the number of microorganisms in the oral cavity as an index
Scientific Title
Effect of cleaning and gargle after brushing using the number of microorganisms in the oral cavity as an index
Scientific Title:Acronym
Effect of cleaning and gargle after brushing using the number of microorganisms in the oral cavity as an index
Region
| Japan |
Condition
Condition
Healthy individual
Classification by specialty
| Dental medicine | Nursing | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Using the number of bacteria in saliva as an index, examine the effects of oral cleaning and gargle after brushing.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The number of bacteria in saliva is measured immediately after each method (brushing, cleaning the oral cavity, and gargling with water).
The measurement is not invasive and no follow-up is performed after the measurement.
Key secondary outcomes
Medical record survey items (gender, age, medical history, medication status, BMI, number of remaining teeth, presence or absence of mouth breathing, smoking, drinking, oral wetness, plaque, and dental calculus adhesion)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Brushing, cleaning the oral cavity, and gargle with water is performed on healthy subjects.
Interventions/Control_2
The only gargle with water is performed on healthy subjects.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Can be gargled
Key exclusion criteria
Cannot contain gargle
Under 20 years old
Oral cancer patients
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | Madoka |
| Middle name | |
| Last name | Funahara |
Organization
Kyushu Dental University
Division name
Faculty of Dentistry
Zip code
803-8580
Address
2-6-1, Manazuru, Kitakyushu, Fukuoka
TEL
093-285-3109
r17funahara@fa.kyu-dent.ac.jp
Public contact
Name of contact person
| 1st name | Madoka |
| Middle name | |
| Last name | Funahara |
Organization
Kyusyu Dental University
Division name
Faculty of Dentistry
Zip code
803-8580
Address
2-6-1, Manazuru, Kitakyushu, Fukuoka
TEL
093-285-3109
Homepage URL
r17funahara@fa.kyu-dent.ac.jp
Sponsor or person
Institute
School of Oral Health Sciences Kyushu Dental University
Institute
Department
Personal name
Funding Source
Organization
Japan society for the promotion of science
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Review Committee, Kyushu Dental University
Address
2-6-1, Manazuru, Kitakyushu, Japan
Tel
093-285-3011
gakusei@kyu-dent.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 | 12 | Month | 10 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
40
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 | 08 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 09 | Month | 10 | Day |
Anticipated trial start date
| 2020 | Year | 12 | Month | 10 | Day |
Last follow-up date
| 2021 | Year | 12 | 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 | 12 | Month | 02 | Day |
Last modified on
| 2022 | Year | 01 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048638
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
