UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000035880
Receipt number R000040519
Scientific Title A clinical study on the safety of connective tissue graft for Gingival recession.
Date of disclosure of the study information 2019/02/22
Last modified on 2019/08/28 12:59:19

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Basic information

Public title

A clinical study on the safety of connective tissue graft for Gingival recession.

Acronym

Connective tissue graft for Gingival recession.

Scientific Title

A clinical study on the safety of connective tissue graft for Gingival recession.

Scientific Title:Acronym

Connective tissue graft for Gingival recession.

Region

Japan


Condition

Condition

Gingival recession.

Classification by specialty

Dental medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To verify the safety and validity of connective tissue graft for Gingival recession.

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Safety

Key secondary outcomes

Usefulness


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

Treatment

Type of intervention

Maneuver

Interventions/Control_1

connective tissue graft

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

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

A patient MUST:
1)Have a Tooth loss site with gingival resession.
2) Overall good systemic health
3) 20 years and older
4) Signed informed consent

Key exclusion criteria

Patient MUST NOT:
1)Have a severe chronic periodontitis
2)Have a complication of history of malignant tumor
3)Taking anticoagulants or antiplatelet drugs
4)Suspected oral malignant tumor or pre-cancerous state
5)Pregnancy, breastfeeding, or possibility of pregnancy

Target sample size

4


Research contact person

Name of lead principal investigator

1st name Morikuni
Middle name
Last name Tobita

Organization

Juntendo Hospital, Juntendo university school of medicine

Division name

Dental and Oral surgery

Zip code

113-8431

Address

3-1-3, Hongo, Bunkyo-ku, Tokyo, Japan

TEL

03-3813-3111

Email

mtobita@juntendo.ac.jp


Public contact

Name of contact person

1st name Morikuni
Middle name
Last name Tobita

Organization

Juntendo Hospital, Juntendo university school of medicine

Division name

Dental and Oral surgery

Zip code

113-8431

Address

3-1-3, Hongo, Bunkyo-ku, Tokyo, Japan

TEL

03-3813-3111

Homepage URL


Email

mtobita@juntendo.ac.jp


Sponsor or person

Institute

Juntendo University

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor

Juntendo Tokyo Koto Geriatric Medical Center, Juntendo university school of medicine

Name of secondary funder(s)



IRB Contact (For public release)

Organization

Hospital Ethics Committee Juntendo University Hospital

Address

3-1-3, Hongo, Bunkyo-ku, Tokyo, Japan

Tel

03-3814-5672

Email

kenkyu5858@juntendo.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

順天堂大学医学部附属順天堂医院
順天堂大学医学部附属順天堂東京江東高齢者医療センター


Other administrative information

Date of disclosure of the study information

2019 Year 02 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

2018 Year 12 Month 28 Day

Date of IRB


Anticipated trial start date

2019 Year 02 Month 22 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2019 Year 02 Month 15 Day

Last modified on

2019 Year 08 Month 28 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040519


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name