UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000040218
Receipt number R000045874
Scientific Title Analysis of the effect of insulin resistance on periodontal tissues
Date of disclosure of the study information 2020/04/22
Last modified on 2020/04/22 16:42:59

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Basic information

Public title

Analysis of the effect of insulin resistance on periodontal tissues

Acronym

Analysis of the effect of insulin resistance on periodontal tissues

Scientific Title

Analysis of the effect of insulin resistance on periodontal tissues

Scientific Title:Acronym

Analysis of the effect of insulin resistance on periodontal tissues

Region

Japan


Condition

Condition

Periodontal disease

Classification by specialty

Dental medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this study is to find out whether insulin resistance is expressed in periodontal tissues and how it occurs.

Basic objectives2

Bio-equivalence

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable


Assessment

Primary outcomes

Periodontal tissue examination such as pocket probing depth and bleeding during probing

Key secondary outcomes

Blood glucose, HbA1C and other diabetes, and laboratory tests associated with metabolic syndrome


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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1) Men and women over the age of 20
2) Those who have been diagnosed as needing periodontal surgery with gingival resection, and those who need tooth extraction.
3) A person who can refer the blood glucose level, HbA1C, free fatty acid level, etc. by medical examination or internal medical examination at the time of preoperative medical interview for the above treatment and bring the test result.

Key exclusion criteria

Patients who have been confirmed to have infectious diseases such as hepatitis B, hepatitis C, and HIV by an interview with doctor

Target sample size

30


Research contact person

Name of lead principal investigator

1st name Koji
Middle name
Last name Mizutani

Organization

Tokyo Medical and Dental University

Division name

Department of Periodontology

Zip code

113-8549

Address

1-5-45 Yushima, Bunkyo-ku, Tokyo

TEL

03-5803-5488

Email

mizuperi@tmd.ac.jp


Public contact

Name of contact person

1st name Koji
Middle name
Last name Mizutani

Organization

Tokyo Medical and Dental University

Division name

Department of Periodontology

Zip code

113-8549

Address

1-5-45 Yushima, Bunkyo-ku, Tokyo

TEL

03-5803-5488

Homepage URL


Email

mizuperi@tmd.ac.jp


Sponsor or person

Institute

Department of Periodontology, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University (TMDU)

Institute

Department

Personal name



Funding Source

Organization

Ministry of education

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Tokyo Medical and Dental University

Address

1-5-45 Yushima, Bunkyo-ku, Tokyo

Tel

+81-3-5803-5488

Email

mizuperi@tmd.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

東京医科歯科大学病院(東京都)


Other administrative information

Date of disclosure of the study information

2020 Year 04 Month 22 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

2014 Year 06 Month 04 Day

Date of IRB

2014 Year 08 Month 19 Day

Anticipated trial start date

2014 Year 08 Month 19 Day

Last follow-up date

2021 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

The expression of insulin resistance in periodontal tissues was examined by experiments using tissues and cells obtained from the three samples obtained without adverse events. It has been suggested that samples obtained from humans with diabetes show a propensity for insulin resistance. Further detailed analysis will be conducted in the future.


Management information

Registered date

2020 Year 04 Month 22 Day

Last modified on

2020 Year 04 Month 22 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045874


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name