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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000040218
Receipt No. 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

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

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
URL(English) https://upload.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


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