UMIN-CTR Clinical Trial

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