UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047625 |
|---|---|
| Receipt number | R000054305 |
| Scientific Title | Clinical study of bone filling materials Osferion and BioOss for bone gain in implant surgery and bone regeneration in bone defects |
| Date of disclosure of the study information | 2022/04/29 |
| Last modified on | 2022/04/28 22:45:50 |
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Basic information
Public title
Clinical study of bone filling materials Osferion and BioOss for bone gain in implant surgery and bone regeneration in bone defects
Acronym
Clinical study of bone filling materials Osferion and BioOss for bone gain in implant surgery and bone regeneration in bone defects
Scientific Title
Clinical study of bone filling materials Osferion and BioOss for bone gain in implant surgery and bone regeneration in bone defects
Scientific Title:Acronym
Clinical study of bone filling materials Osferion and BioOss for bone gain in implant surgery and bone regeneration in bone defects
Region
| Japan |
Condition
Condition
missing teeth
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Study the bone regeneration ability of cistern bone and jaw bone by bone filling material.
Basic objectives2
Others
Basic objectives -Others
biological safty
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
bone augmentation
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
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
artificial bone
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
Patients who are judged to need to be compensated for bone defects with artificial bone
Key exclusion criteria
Patients who are judged to be unnecessary to compensate for bone defects with artificial bone
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | inoue |
| Middle name | |
| Last name | kazuya |
Organization
osaka medical and Pharmaceutical University
Division name
oral surgery
Zip code
569-8686
Address
osaka. takatsuki
TEL
0726831221
kazuya.inoue@ompu.ac.jp
Public contact
Name of contact person
| 1st name | inoue |
| Middle name | |
| Last name | kazuya |
Organization
osaka medical and Pharmaceutical University
Division name
oral surgery
Zip code
569-8686
Address
takatsuki,osaka
TEL
0726831221
Homepage URL
kazuya.inoue@ompu.ac.jp
Sponsor or person
Institute
osaka medical and Pharmaceutical University
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Faculty of oral surgery.osaka medical and Pharmaceutical University
Address
takatsuki,osaka
Tel
0726831221
kazuya.inoue@ompu.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
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 04 | Month | 29 | 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
| 2013 | Year | 07 | Month | 25 | Day |
Date of IRB
| 2013 | Year | 07 | Month | 25 | Day |
Anticipated trial start date
| 2020 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 04 | Month | 28 | Day |
Last modified on
| 2022 | Year | 04 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054305
