UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000015086
Receipt number R000017556
Scientific Title Survey of periodontal condition in Japanese citizens
Date of disclosure of the study information 2014/10/01
Last modified on 2021/09/13 12:46:31

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Basic information

Public title

Survey of periodontal condition in Japanese citizens

Acronym

Survey of periodontal condition in Japanese citizens

Scientific Title

Survey of periodontal condition in Japanese citizens

Scientific Title:Acronym

Survey of periodontal condition in Japanese citizens

Region

Japan


Condition

Condition

periodontal disease

Classification by specialty

Dental medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To survey periodontal condition of generally healthy people

Basic objectives2

Others

Basic objectives -Others

To analyze the relationship between periodontal disease and systemic diseases

Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

Antibody level against periodontal bacteria

Key secondary outcomes

Counts of periodontal bacteria
Probing pocket depth
Clinical attachment level


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

Generally healthy people except for periodontal disease

Key exclusion criteria

Severe systemic diseases

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yuichi Izumi

Organization

Tokyo Medical and Dental University

Division name

Peridontology

Zip code


Address

1-5-45, Yushima, Bunkyo, Tokyo

TEL

03-5803-5488

Email

y-izumi.peri@tmd.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Norio Aoyama

Organization

Tokyo Medical and Dental University

Division name

Peridontology

Zip code


Address

1-5-45, Yushima, Bunkyo, Tokyo

TEL

03-5803-5488

Homepage URL


Email

aoyama@kdu.ac.jp


Sponsor or person

Institute

Tokyo Medical and Dental University

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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

東京医科医科大学(東京都)、日本健康美容協会(群馬県)


Other administrative information

Date of disclosure of the study information

2014 Year 10 Month 01 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

2014 Year 10 Month 13 Day

Date of IRB

2012 Year 03 Month 29 Day

Anticipated trial start date

2014 Year 10 Month 14 Day

Last follow-up date

2016 Year 03 Month 01 Day

Date of closure to data entry

2016 Year 03 Month 01 Day

Date trial data considered complete

2017 Year 03 Month 31 Day

Date analysis concluded

2018 Year 03 Month 31 Day


Other

Other related information

We will analize the data from this study with the data which we are now collecting from patients with cardiovascular disease.


Management information

Registered date

2014 Year 09 Month 08 Day

Last modified on

2021 Year 09 Month 13 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017556