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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000036801
Receipt No. R000041932
Scientific Title Verification of the effect of oral dysbiosis on gut dysbiosis.
Date of disclosure of the study information 2019/05/24
Last modified on 2019/05/20

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Basic information
Public title Effect of periodontitis on gut microbiome.
Acronym Effect of periodontitis on gut microbiome.
Scientific Title Verification of the effect of oral dysbiosis on gut dysbiosis.
Scientific Title:Acronym Verification of the effect of oral dysbiosis on gut dysbiosis.
Region
Japan

Condition
Condition Periodontitis
Classification by specialty
Dental medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To compare the profile of gut microbiome as well as saliva microbiome of periodontitis patients with those of otherwise healthy subjects.
Basic objectives2 Others
Basic objectives -Others To investigate the effect of periodontal therapy on gut microbiome
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Gut microbiome
Key secondary outcomes Saliva microbiome

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
20 years-old <=
Age-upper limit
80 years-old >=
Gender Male and Female
Key inclusion criteria Diagnosed as chronic or aggressive periodontitis
Good general health without any remarkable past history except well controlled hypertension and dyslipidemia
Presence of at least 15 remaining teeth; presence of at least 2 teeth with probing pocket depth.
> 5 mm with concomitant bleeding on probing.
Key exclusion criteria Use of systemic antimicrobials in the past 3 months.
Being pregnant or suspected pregnancy.
Having uncontrolled diabetes, severe heart disease, kidney dysfunction, or other diseases not suitable for this investigation.
Target sample size 80

Research contact person
Name of lead principal investigator
1st name Kazuhisa
Middle name
Last name Yamazaki
Organization Niigata University Graduate School of Medical and Dental Sciences
Division name Division of Oral Science for Health Promotion
Zip code 951-8514
Address 2-5274 Gakko-cho, Chuo-ku, Niigata
TEL 0252270744
Email kaz@dent.niigata-u.ac.jp

Public contact
Name of contact person
1st name Keisuke
Middle name
Last name Sato
Organization Niigata University Graduate School of Medical and Dental Sciences
Division name Division of Peridontology
Zip code 951-8514
Address 2-5274 Gakko-cho, Chuo-ku, Niigata
TEL 81252272872
Homepage URL
Email keisuke@dent.niigata-u.ac.jp

Sponsor
Institute Niigata Univesity Hospital
Institute
Department

Funding Source
Organization Japan Society for the Promotion of Science
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 Institutiona Review Board of the Niigata University
Address 2-5274 Gakkomachi, Chuo-ku, Niigata
Tel 81252270744
Email kaz@dent.niigata-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
2019 Year 05 Month 24 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
2019 Year 03 Month 05 Day
Date of IRB
2019 Year 03 Month 05 Day
Anticipated trial start date
2019 Year 03 Month 05 Day
Last follow-up date
2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Periodontal examination
Analyses of serum biomarkers

Management information
Registered date
2019 Year 05 Month 20 Day
Last modified on
2019 Year 05 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041932

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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