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
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
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
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
