UMIN-CTR Clinical Trial

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
Institute	Juntendo University
Institute
Department

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040519