UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000062425 |
|---|---|
| Receipt number | R000062661 |
| Scientific Title | Evaluation of the relationship between oral microbiota and daily habits in terms of diet and oral cleaning |
| Date of disclosure of the study information | 2026/08/10 |
| Last modified on | 2026/07/31 15:41:16 |
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Basic information
Public title
Evaluation of the relationship between oral microbiota and daily habits in terms of diet and oral cleaning
Acronym
Evaluation of the relationship between oral microbiota and daily habits
Scientific Title
Evaluation of the relationship between oral microbiota and daily habits in terms of diet and oral cleaning
Scientific Title:Acronym
Evaluation of the relationship between oral microbiota and daily habits
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Recently, the influence of the oral microbiota not only on oral diseases but also on systemic diseases has been focused. While the oral microflora is reported to be diverse from individual to individual, the factors that influence the diversity are yet to be elucidated. In addition, most studies on oral microflora have focused on saliva and dental plaque samples, and there have been few studies specifically on the tongue coating.
In this research project, we will collect oral bacteria from tongue coating and analyze the composition and diversity of the oral microflora of individual subjects by next-generation sequencing analysis, and 1. clarify the dietary habit factors that influence the diversity by using the BDHQ dietary habit questionnaire survey. 2. clarify whether the diversity of oral microflora is changed by the intervention of tongue cleaning as an oral cleaning habit.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Diversity of the microbiota of tongue coating
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Daily Tongue blushing once a day for 10 days
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
| 20 | years-old | <= |
Age-upper limit
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
People who are able to obtain written consent to participate in the research from the individual by their own will
Key exclusion criteria
1.People who are scheduled for dental treatment during the study period
2.People who need to take antibiotics one month prior to the study period and during the study period
3.Denture wearers
4.People who habitually clean their tongue
5.Smorkers
6.Pregnant woman
7.People with a vomiting reflex and difficulty contacting the tongue
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | MARIKO |
| Middle name | |
| Last name | MATSUMOTO |
Organization
National Institute of Advanced Industrial Science And Technology(AIST)
Division name
Oral Frail Research Group, Health and Medical Research Institute
Zip code
7610395
Address
2217-14, Hayashimati, Takamathu-shi, Kagawa
TEL
05035224822
aoki-matsumoto.mariko@aist.go.jp
Public contact
Name of contact person
| 1st name | MARIKO |
| Middle name | |
| Last name | MATSUMOTO |
Organization
National Institute of Advanced Industrial Science And Technology(AIST)
Division name
Oral Frail Research Group, Health and Medical Research Institute
Zip code
7610395
Address
2217-14, Hayashimati, Takamathu-shi, Kagawa
TEL
05035224822
Homepage URL
aoki-matsumoto.mariko@aist.go.jp
Sponsor or person
Institute
National Institute of Advanced Industrial Science And Technology(AIST)
Institute
Department
Personal name
Funding Source
Organization
National Institute of Advanced Industrial Science And Technology(AIST)
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
National Institute of Advanced Industrial Science And Technology(AIST)
Address
2217-14, Hayashimati, Takamathu-shi, Kagawa
Tel
05035224822
aoki-matsumoto.mariko@aist.go.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
| 2026 | Year | 08 | Month | 10 | 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
No longer recruiting
Date of protocol fixation
| 2024 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 08 | Month | 20 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 23 | Day |
Last follow-up date
| 2027 | 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
| 2026 | Year | 07 | Month | 31 | Day |
Last modified on
| 2026 | Year | 07 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062661
