UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042586 |
|---|---|
| Receipt number | R000047965 |
| Scientific Title | Change of salivary microbiome in dentists after 6-week daily advanced oral self-care: A retrospective study for consideration of healthy salivary microbiome. |
| Date of disclosure of the study information | 2020/11/30 |
| Last modified on | 2023/06/01 09:16:38 |
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Basic information
Public title
Change of salivary bacterial flora after oral cleaning in dentist.
Acronym
Elucidation of healthy salivary bacterial flora.
Scientific Title
Change of salivary microbiome in dentists after 6-week daily advanced oral self-care: A retrospective study for consideration of healthy salivary microbiome.
Scientific Title:Acronym
Elucidation of healthy salivary microbiome.
Region
| Japan |
Condition
Condition
Periodontal diseases
Classification by specialty
| Dental medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Elucidation of healthy salivary microbiome.
Basic objectives2
Others
Basic objectives -Others
We have to understand Health to evaluate Diseases. We need further accumulation of comprehensions to establish the identity of the healthy oral microbiome. The aim of the study is to present the reliable healthy salivary microbiome.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change of bacterial diversity after 6-week daily advanced oral self-care in salivary microbiome.
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
| 28 | years-old | <= |
Age-upper limit
| 51 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Participation in previous interventional study to provide saliva samples.
Inclusion criteria in the previous interventional study.
- Being dentist.
- Having 24 functioning teeth or more.
- Being interested in the study.
- Awareness of oral and systemic own good health condition.
- Intention of adherence to an instructed oral self-care
Key exclusion criteria
Withdrawal from the study participation.
exclusion criteria in the previous interventional study.
- Positive for salivary occult blood test (Sunstar, Osaka, Japan).
- Necessity for dental treatment.
- Presence of a partially impacted tooth.
- Smoker.
- Pregnant or breast-feeding woman.
- Having used systemic antibiotics within the previous 3 months.
- Regular medication for any other chronic disease.
- Participation in another clinical trial.
Target sample size
8
Research contact person
Name of lead principal investigator
| 1st name | Nobuhiro |
| Middle name | |
| Last name | Hanada |
Organization
Tsurumi University
Division name
School of Dental Medicine
Zip code
230-8501
Address
2-1-3 Tsurumi, Yokohama Japan
TEL
0455808461
hanada-n@tsurumi-u.ac.jp
Public contact
Name of contact person
| 1st name | Takatoshi |
| Middle name | |
| Last name | Murata |
Organization
Tsurumi University
Division name
School of Dental Medicine
Zip code
230-8501
Address
2-1-3 Tsurumi Yokohama
TEL
0455808462
Homepage URL
murata-ta@tsurumi-u.ac.jp
Sponsor or person
Institute
Tsurumi University School of Dental Medicine, Department of Translational Research
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science (JSPS)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee of Tsurumi University School of Dental Medicine
Address
2-1-3 Tsurumi Yokohama
Tel
0455808318
kyoken@tsurumi-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
| 2020 | Year | 11 | Month | 30 | 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
8
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
| 2020 | Year | 11 | Month | 16 | Day |
Date of IRB
| 2020 | Year | 11 | Month | 16 | Day |
Anticipated trial start date
| 2020 | Year | 11 | Month | 17 | Day |
Last follow-up date
| 2021 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Saliva samples from previous studies (June 2014-October 2014) will be used. Therefore, no new intervention will be carried out.
All subjects were collaborators and agreed to store their saliva samples for future use.
This study plan using stored saliva was approved by the IRB.
Management information
Registered date
| 2020 | Year | 11 | Month | 28 | Day |
Last modified on
| 2023 | Year | 06 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047965
| 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 |
