UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027850 |
|---|---|
| Receipt number | R000031906 |
| Scientific Title | The prospective observational study of bone graft material GCAP-01 |
| Date of disclosure of the study information | 2017/06/22 |
| Last modified on | 2025/12/26 15:25:57 |
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Basic information
Public title
The prospective observational study of bone graft material GCAP-01
Acronym
The prospective observational study of bone graft material GCAP-01
Scientific Title
The prospective observational study of bone graft material GCAP-01
Scientific Title:Acronym
The prospective observational study 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
Radiographycal analysis
Key secondary outcomes
Adverse events
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
Patients who participate in clinical trials of bone graft material GCAP-01.
Key exclusion criteria
Patient who did not give written informed consent.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Keiko |
| Middle name | |
| Last name | Kudoh |
Organization
Tokushima University Hospital
Division name
Oral Surgery
Zip code
7708504
Address
2-50-1, Kuramoto-cho, Tokushima, JAPAN
TEL
088-633-7354
kkudoh@tokushima-u.ac.jp
Public contact
Name of contact person
| 1st name | Keiko |
| Middle name | |
| Last name | Kudoh |
Organization
Tokushima University Hospital
Division name
Oral Surgery
Zip code
7708504
Address
2-50-1, Kuramoto-cho, Tokushima, JAPAN
TEL
088-633-7354
Homepage URL
kkudoh@tokushima-u.ac.jp
Sponsor or person
Institute
Tokushima University Hospital
Institute
Department
Personal name
Funding Source
Organization
Tokushima University Hospital
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
Clinical Research Center for Developmental Therapeutics
Address
2-50-1, Kuramoto-cho, Tokushima, JAPAN
Tel
0886339294
awachiken@tokushima-u.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
東京医科歯科大学歯学部附属病院（東京都）、九州大学病院（福岡県）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 06 | Month | 22 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
14
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
No longer recruiting
Date of protocol fixation
| 2017 | Year | 06 | Month | 14 | Day |
Date of IRB
| 2017 | Year | 07 | Month | 24 | Day |
Anticipated trial start date
| 2017 | Year | 07 | Month | 15 | Day |
Last follow-up date
| 2027 | Year | 07 | Month | 15 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
nothing in particular
Management information
Registered date
| 2017 | Year | 06 | Month | 21 | Day |
Last modified on
| 2025 | Year | 12 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031906
