UMIN-CTR Clinical Trial

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://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052713