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
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
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
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
