UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055975 |
|---|---|
| Receipt number | R000063973 |
| Scientific Title | The effect of tooth brushing and mouthwash on inhibiting bacteria in saliva |
| Date of disclosure of the study information | 2024/10/29 |
| Last modified on | 2024/10/29 10:22:18 |
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Basic information
Public title
The effect of tooth brushing and mouthwash on inhibiting bacteria in saliva
Acronym
The effect of tooth brushing and mouthwash on inhibiting bacteria in saliva
Scientific Title
The effect of tooth brushing and mouthwash on inhibiting bacteria in saliva
Scientific Title:Acronym
The effect of tooth brushing and mouthwash on inhibiting bacteria in saliva
Region
| Japan |
Condition
Condition
healthy volunteer
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aimed to determine whether brushing, followed by mouth-washing with water or povidone-iodine, can reduce salivary bacterial counts and assess the duration of these effects.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change of bacteria count in saliva before and after tooth brushing and gargling
Effects of mouthwash
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
This study included 20 healthy volunteering students and staff members of Nagasaki University School of Dentistry, aged over 18.
Key exclusion criteria
Patients with a history of hypersensitivity to iodine, a component of mouthwash
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Yuichi |
| Middle name | |
| Last name | Nakamura |
Organization
Nagasaki University Graduate School of Biomedical Sciences
Division name
Preventive Dentistry
Zip code
852-8588
Address
1-7-1, Sakamoto, Nagasaki
TEL
095-819-7663
sakiko@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Sakiko |
| Middle name | |
| Last name | Soutome |
Organization
Nagasaki University
Division name
Preventive Dentistry
Zip code
852-8588
Address
1-7-1, Sakamoto,
TEL
+818017063341
Homepage URL
sakiko@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki University
Institute
Department
Personal name
Funding Source
Organization
Nagasaki University
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
Institution Review Bpard of Nagasaki University
Address
1-7-1, Sakamoto, Nagasaki
Tel
0958197229
gakujutu_gakuji@ml.nagasaki-u.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 | 10 | Month | 29 | 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
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
| 2023 | Year | 06 | Month | 19 | Day |
Date of IRB
| 2023 | Year | 06 | Month | 19 | Day |
Anticipated trial start date
| 2023 | Year | 06 | Month | 20 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2024 | Year | 10 | Month | 29 | Day |
Last modified on
| 2024 | Year | 10 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063973
