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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000046212
Receipt No. R000052713
Scientific Title Whole genome sequencing and gene polymorphism analysis of aggressive periodontitis
Date of disclosure of the study information 2021/12/01
Last modified on 2021/11/29

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Basic information
Public title Whole genome sequencing and gene polymorphism analysis of aggressive periodontitis
Acronym Whole genome sequencing and gene polymorphism analysis of aggressive periodontitis
Scientific Title Whole genome sequencing and gene polymorphism analysis of aggressive periodontitis
Scientific Title:Acronym Whole genome sequencing and gene polymorphism analysis of aggressive periodontitis
Region
Japan

Condition
Condition aggressive periodontitis
Classification by specialty
Dental medicine
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 Creating a database of patients with aggressive periodontitis and elucidating the causative gene or disease susceptibility gene by whole-genome analysis and gene polymorphism analysis of aggressive periodontitis.
Basic objectives2 Others
Basic objectives -Others This study is conducted at the Osaka University Dental Hospital as the main facility, and the human whole genome analysis of patients diagnosed with aggressive periodontitis and healthy people is performed, and the patients with invasive periodontitis are registered in the public database. We created a database, detected gene polymorphisms such as single-base polymorphisms (SNPs) and insertion deletions (Indels) based on the decoding results, and identified and functionally analyzed the causative genes of agggessive periodontitis. This research aims to be applied to the prevention, diagnosis, and treatment of aggressive periodontitis in the future.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Gene polymorphisms and mutations by decoding DNA sequences
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Other
Interventions/Control_1 Collecting blood for patients with aggressive periodontitis, and extracting DNA.
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
45 years-old >
Gender Male and Female
Key inclusion criteria Significant alveolar bone resorption at a young age
Key exclusion criteria Recognize systemic diseases that affect bone metabolism
Target sample size 40

Research contact person
Name of lead principal investigator
1st name Takeaki
Middle name
Last name Sudo
Organization Tokyo Medical and Dental University
Division name Institute of Education
Zip code 113-8510
Address 1-5-45, Yushima, Bunkyo-ku, Tokyo
TEL 03-5803-4010
Email t-sudo.ioe@tmd.ac.jp

Public contact
Name of contact person
1st name Takeaki
Middle name
Last name Sudo
Organization Tokyo Medical and Dental University
Division name Institute of Education
Zip code 113-8510
Address 1-5-45, Yushima, Bunkyo-ku, Tokyo
TEL 03-5803-4010
Homepage URL
Email t-sudo.ioe@tmd.ac.jp

Sponsor
Institute Department of Periodontology, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University, Tokyo, Japan
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Dental Research Ethics Committee of Tokyo Medical and Dental University
Address 1-5-45, Yushima, Bunkyo-ku, Tokyo
Tel 03-5803-5072
Email d-hyoka.adm@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

Other administrative information
Date of disclosure of the study information
2021 Year 12 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 Preinitiation
Date of protocol fixation
2021 Year 11 Month 29 Day
Date of IRB
Anticipated trial start date
2022 Year 02 Month 01 Day
Last follow-up date
2024 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2021 Year 11 Month 29 Day
Last modified on
2021 Year 11 Month 29 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052713

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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