UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000055724
Receipt number R000063682
Scientific Title Clinical research on cell isolation from gingiva aiming for practical application
Date of disclosure of the study information 2024/10/04
Last modified on 2024/10/03 16:13:28

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Basic information

Public title

Clinical research on cell isolation from gingiva aiming for practical application

Acronym

Clinical research on cell isolation from gingiva aiming for practical application

Scientific Title

Clinical research on cell isolation from gingiva aiming for practical application

Scientific Title:Acronym

Clinical research on cell isolation from gingiva aiming for practical application

Region

Japan


Condition

Condition

wisdom tooth

Classification by specialty

Surgery in general Cardiovascular surgery Dental medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To verify banking of cells from gingiva

Basic objectives2

Others

Basic objectives -Others

To verify banking of cells isolated from excised gingiva in treatment of wisdom tooth extraction

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

To establish 10 cell lines from excised gingiva

Key secondary outcomes



Base

Study type

Others,meta-analysis etc


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

18 years-old <=

Age-upper limit

30 years-old >=

Gender

Male and Female

Key inclusion criteria

1) Patients with written informed consent based on the free will of the patient after receiving sufficient explanation
2) Patients aged 18 to 30 years old at the time of obtaining consent
3) No gender restriction
4) Patients scheduled to undergo wisdom tooth extraction 3 weeks after obtaining consent

Key exclusion criteria

1) Patients judged to be unsuitable as a research subject by researchers

Target sample size

10


Research contact person

Name of lead principal investigator

1st name Kimikazu
Middle name
Last name Hamano

Organization

Yamaguchi University

Division name

Department of Surgery and Clinical Science, Graduate School of Medicine

Zip code

7558505

Address

1-1-1 Minami-kogushi, Ube, Yamaguchi, Japan

TEL

0836-22-2261

Email

cres-sg1@yamaguchi-u.ac.jp


Public contact

Name of contact person

1st name Koji
Middle name
Last name Ueno

Organization

Yamaguchi University

Division name

Department of Surgery and Clinical Science, Graduate School of Medicine

Zip code

7558505

Address

1-1-1 Minami-kogushi, Ube, Yamaguchi, Japan

TEL

0836-22-2261

Homepage URL


Email

cres-sg1@yamaguchi-u.ac.jp


Sponsor or person

Institute

Yamaguchi University

Institute

Department

Personal name



Funding Source

Organization

Self funding

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor

Central Glass Co., Ltd.

Name of secondary funder(s)



IRB Contact (For public release)

Organization

Yamaguchi University Research Ethics Committee

Address

1-1-1 Minami-kogushi, Ube, Yamaguchi, Japan

Tel

0836-22-2428

Email

me223@yamaguchi-u.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

2024 Year 10 Month 04 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

2024 Year 08 Month 05 Day

Date of IRB

2024 Year 10 Month 02 Day

Anticipated trial start date

2024 Year 10 Month 04 Day

Last follow-up date

2029 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

To establish 10 cell lines from excised gingiva in the treatment after wisdom tooth extraction


Management information

Registered date

2024 Year 10 Month 03 Day

Last modified on

2024 Year 10 Month 03 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063682