UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059273 |
|---|---|
| Receipt number | R000067797 |
| Scientific Title | Preliminary study on the effect of pre-bedtime oral care on the oral environment upon early morning awakening |
| Date of disclosure of the study information | 2025/10/11 |
| Last modified on | 2025/10/10 16:38:07 |
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Basic information
Public title
Preliminary study on the effect of pre-bedtime oral care on the oral environment upon early morning awakening
Acronym
Preliminary study on the effect of pre-bedtime oral care on the oral environment upon early morning awakening
Scientific Title
Preliminary study on the effect of pre-bedtime oral care on the oral environment upon early morning awakening
Scientific Title:Acronym
Preliminary study on the effect of pre-bedtime oral care on the oral environment upon early morning awakening
Region
| Japan |
Condition
Condition
Healthy people
Classification by specialty
| Nursing |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate the effect of oral care using mouthwash before bedtime on the number of oral bacteria and oral moisture content upon waking the next morning in healthy middle-aged and elderly adults.
Basic objectives2
Others
Basic objectives -Others
Quantitative evaluation
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Oral bacteria count
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
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
| Other |
Interventions/Control_1
Intervention 1: One day of oral care including brushing and rinsing with mouthwash before going to bed - Two-day washout period - One day of oral care including brushing and rinsing with distilled water before going to bed
Interventions/Control_2
Intervention 2: One day of oral care including brushing and rinsing with distilled water before going to bed - Two-day washout period - One day of oral care including brushing and rinsing with mouthwash before going to bed
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
| 40 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Participants who can gargle with mouthwash.
2) Participants who do not normally use mouthwash.
3) Participants who can use the toothpaste used in the study during the study period.
4) Participants who can adjust to the designated wake-up time during the study period.
Key exclusion criteria
1) Subjects currently undergoing dental treatment, such as caries treatment
2) Subjects who have received antibiotic treatment within the past two weeks
3) Subjects with no teeth
4) Subjects who have a habit of drinking fluids between the time of bedtime and the time of waking the next morning
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Yukiko |
| Middle name | |
| Last name | Sakamoto |
Organization
Wakayama Medical University
Division name
School of Health and Nursing Science
Zip code
641-0011
Address
580 Mikazura, Wakayama City Japan
TEL
+81-73-446-6700
sakamoto-nc@wakayama-med.ac.jp
Public contact
Name of contact person
| 1st name | Yukiko |
| Middle name | |
| Last name | Sakamoto |
Organization
Wakayama Medical University
Division name
School of Health and Nursing Science
Zip code
6410011
Address
580 Mikazura, Wakayama City Japan
TEL
+81-73-446-6700
Homepage URL
sakamoto-nc@wakayama-med.ac.jp
Sponsor or person
Institute
Wakayama Medical University
Institute
Department
Personal name
Yukiko Sakamoto
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee of Wakayama Medical University
Address
811-1 Kimiidera, Wakayama, Wakayama Prefecture 641-8509, Japan
Tel
+81-73-447-2300ext.3692,
wa-rinri@wakayama-med.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
| 2025 | Year | 10 | Month | 11 | 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
| 2025 | Year | 09 | Month | 22 | Day |
Date of IRB
| 2025 | Year | 10 | Month | 03 | Day |
Anticipated trial start date
| 2025 | Year | 10 | Month | 10 | Day |
Last follow-up date
| 2025 | 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
| 2025 | Year | 10 | Month | 02 | Day |
Last modified on
| 2025 | Year | 10 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067797
