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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000042586
Receipt No. 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 2020/11/28

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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
Email 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
Email murata-ta@tsurumi-u.ac.jp

Sponsor
Institute Tsurumi University School of Dental Medicine, Department of Translational Research
Institute
Department

Funding Source
Organization Japan Society for the Promotion of Science (JSPS)
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 Ethics Committee of Tsurumi University School of Dental Medicine
Address 2-1-3 Tsurumi Yokohama
Tel 0455808318
Email 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
2020 Year 11 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047965

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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