UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019281 |
|---|---|
| Receipt number | R000022289 |
| Scientific Title | Clinical trial of bone graft material GCAP-01 |
| Date of disclosure of the study information | 2017/08/31 |
| Last modified on | 2018/01/27 17:38:04 |
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Basic information
Public title
Clinical trial of bone graft material GCAP-01
Acronym
Clinical trial of bone graft material GCAP-01
Scientific Title
Clinical trial of bone graft material GCAP-01
Scientific Title:Acronym
Clinical trial of bone graft material GCAP-01
Region
| Japan |
Condition
Condition
Bone defect around dental implant
Classification by specialty
| Oral surgery | Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of bone regeneration by GCAP-01 application for bone defect around dental implant
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluation of osseointegration
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
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Implantation of GCAP-01 to bone defect around dental implant.
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Age: 20 years of age and older, and below 80 years old
Patients who provided voluntary informed consent to participate in the study after receiving sufficient explanation.
Patients, who are judged to be appropriate for entry by the trial responsible (collaborative) doctor
Key exclusion criteria
Patient who has a bone metabolism disease like osteoporosis or has a medication of bisphosphonate.
Patient who has a medication of steroid or immunosuppressant (The local administration is excluded).
Patient who is pregnant, possibly pregnant, nursing or considering pregnancy.
Patient who has an uncontroled diabetes.
Patient who participated other clinical trial program within 3 months prior to the study entry
Others, patient who is unfit for the study as determined by the trial responsible (collaborative) doctor
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tomohiro Kumagai |
Organization
GC Corporation
Division name
R&D Department
Zip code
Address
76-1, Hasunuma-cho, Itabashi-ku, Tokyo
TEL
03-3965-1233
katsuyuki_yamanaka@mb.gcdental.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomohiro Kumagai |
Organization
GC Corporation
Division name
R&D Department
Zip code
Address
76-1, Hasunuma-cho, Itabashi-ku, Tokyo
TEL
03-3965-1233
Homepage URL
katsuyuki_yamanaka@mb.gcdental.co.jp
Sponsor or person
Institute
GC Corporation
Institute
Department
Personal name
Funding Source
Organization
GC Corporation
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2017 | Year | 08 | Month | 31 | 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
Completed
Date of protocol fixation
| 2015 | Year | 07 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 07 | Month | 28 | Day |
Last follow-up date
| 2016 | Year | 11 | Month | 25 | Day |
Date of closure to data entry
| 2017 | Year | 03 | Month | 21 | Day |
Date trial data considered complete
| 2017 | Year | 03 | Month | 21 | Day |
Date analysis concluded
| 2017 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 10 | Month | 08 | Day |
Last modified on
| 2018 | Year | 01 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022289
