UMIN-CTR Clinical Trial

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

Men and women

Classification by specialty

Dental medicine

Adult

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Hiyoshi Oral Health Clinics

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Lion Corporation

Name of secondary funder(s)

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

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2018

Year

02

Month

16

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Completed

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 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.

Registered date

2018

Year

02

Month

16

Day

Last modified on

2023

Year

06

Month

30

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035767