UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000036801
Receipt number 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 2023/05/23 10:48:19

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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 or person

Institute

Niigata Univesity Hospital

Institute

Department

Personal name



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

Completed

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

2021 Year 03 Month 31 Day

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

2023 Year 05 Month 23 Day



Link to view the page

Value
https://center6.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