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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000019281
Receipt No. 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

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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
Email 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
Email katsuyuki_yamanaka@mb.gcdental.co.jp

Sponsor
Institute GC Corporation
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022289

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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