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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000031334
Receipt No. R000035767
Scientific Title Comparative analysis of oral and intestinal environment in healthy subject and patients with oral disease.
Date of disclosure of the study information 2018/02/16
Last modified on 2020/02/18

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Basic information
Public title Comparative analysis of oral and intestinal environment in healthy subject and patients with oral disease.
Acronym Comparative analysis of oral and intestinal environment in healthy subject and patients with oral disease.
Scientific Title Comparative analysis of oral and intestinal environment in healthy subject and patients with oral disease.
Scientific Title:Acronym Comparative analysis of oral and intestinal environment in healthy subject and patients with oral disease.
Region
Japan

Condition
Condition Men and women
Classification by specialty
Dental medicine Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify relationship between oral and intestinal environment in healthy subject and patients with oral disease.
Basic objectives2 Others
Basic objectives -Others Research
Trial characteristics_1 Exploratory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes 16S rRNA gene-based metagenome analysis and metabolome analysis of oral cavity samples
Key secondary outcomes * 16S rRNA gene-based metagenome analysis and metabolome analysis of fecal samples
* Background research
* Questionnaire

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
100 years-old >=
Gender Male and Female
Key inclusion criteria (A-1) Males and females aged 20 to 65 years old.
(A-2) Subjects who don't regularly use specific medicines.
(A-3) Subjects who show understanding of the study procedures and agreement with participating the study by written informed consent prior to the study.

(B-1) Males and females aged 20 to 79 years old.
(B-2) Subjects who are found carious pit that are required therapy in adult tooth by visual or X-ray.
(B-3) Subjects who show understanding of the study procedures and agreement with participating the study by written informed consent prior to the study.

(C-1) Males and females aged 20 to 79 years old.
(C-2) Subjects who have at least 1 periodontal pockets that are 4 mm or deeper with bleeding.
(C-3) Subjects who do not have carious pit.
(C-4) Subjects who show understanding of the study procedures and agreement with participating the study by written informed consent prior to the study.

(D-1) Males and females aged 20 to 79 years old.
(D-2) Subjects who do not have periodontal pockets that are 4 mm or deeper.
(D-3) Subjects who have 10% or less bleeding tooth surface.
(D-4) Subjects who do not have carious pit.
(D-5) Subjects who show understanding of the study procedures and agreement with participating the study by written informed consent prior to the study.

(E-1) Males and females aged 80 to 100 years old.
(E-2) Subjects who have 26 or greater original teeth.
(E-3) Subjects who did not receive treatment of carious or periodontal disease during last 10 years.
(E-4) Subjects who show understanding of the study procedures and agreement with participating the study by written informed consent prior to the study.
Key exclusion criteria (A-1) Subjects who have denture or implants.
(A-2) Smoker
(A-3) Subjects who consumed antibiotics during last 6 months.
(A-4) Subjects who did mouth cleaning, eating, or drinking except water during last 1 hour.
(A-5) Subjects who did mouth cleaning from last night to sampling.
(A-6) Subjects who is pregnant.
(A-7) Subjects who have been determined ineligible by principal investigator.

(B-1) Subjects who have denture or implants.
(B-2) Smoker
(B-3) Subjects who consumed antibiotics during last 6 months.
(B-4) Subjects who is in orthodontic treatment.
(B-5) Subjects who did mouth cleaning, eating, or drinking except water during last 1 hour.
(B-6) Subjects who is pregnant.
(B-7) Subjects who have been determined ineligible by principal investigator.

(C-1) Subjects who have denture or implants.
(C-2) Smoker
(C-3) Subjects who consumed antibiotics during last 6 months.
(C-4) Subjects who is in orthodontic treatment.
(C-5) Subjects who did mouth cleaning, eating, or drinking except water during last 1 hour.
(C-6) Subjects who is pregnant.
(C-7) Subjects who have been determined ineligible by principal investigator.

(D-1) Subjects who have denture or implants.
(D-2) Smoker
(D-3) Subjects who consumed antibiotics during last 6 months.
(D-4) Subjects who is in orthodontic treatment.
(D-5) Subjects who did mouth cleaning, eating, or drinking except water during last 1 hour.
(D-6) Subjects who is pregnant.
(D-7) Subjects who have been determined ineligible by principal investigator.

(E-1) Subjects who did mouth cleaning, eating, or drinking except water during last 1 hour.
(E-2) Subjects who have been determined ineligible by principal investigator.
Target sample size 150

Research contact person
Name of lead principal investigator
1st name Takashi
Middle name
Last name Kumagai
Organization Hiyoshi Oral Health Clinics
Division name Headquarters
Zip code 998-0037
Address Hiyoshi-cho 2-1-16, Sakata-shi, Yamagata, Japan
TEL +81-234-22-1837
Email takashi.kumagai@hiyoshi-dental.org

Public contact
Name of contact person
1st name Shinnosuke
Middle name
Last name Murakami
Organization Metabologenomics, Inc.
Division name Headquarters
Zip code 997-0052
Address 246-2 Mizukami, Kakuganji, Tsuruoka, Yamagata, Japan
TEL +81-235-64-0330
Homepage URL
Email research@metagen.co.jp

Sponsor
Institute Hiyoshi Oral Health Clinics
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Lion Corporation
Name of secondary funder(s)

IRB Contact (For public release)
Organization Chiyoda Paramedical Care Clinic
Address 3-3-5 Uchikanda, Chiyoda-ku, Tokyo
Tel +81-3-5297-5548
Email IRB@cpcc.co.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
2018 Year 02 Month 16 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 Enrolling by invitation
Date of protocol fixation
2018 Year 02 Month 15 Day
Date of IRB
2018 Year 02 Month 15 Day
Anticipated trial start date
2018 Year 02 Month 17 Day
Last follow-up date
2020 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Study design: Research

Subjects recruitment method: Subjects will be selected from visitors of dental clinic according to selection criteria and exclusion criteria.

Measurement items:
16S rRNA gene-based metagenome analysis and metabolome analysis of oral and fecal samples.

Management information
Registered date
2018 Year 02 Month 16 Day
Last modified on
2020 Year 02 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035767

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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