UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046212 |
|---|---|
| Receipt number | 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 09:53:29 |
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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
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
t-sudo.ioe@tmd.ac.jp
Sponsor or person
Institute
Department of Periodontology, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University, Tokyo, Japan
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052713
