UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010660 |
|---|---|
| Receipt number | R000012467 |
| Scientific Title | Regeneration of the jawbone using beta-tricalcium phosphate bone graft material |
| Date of disclosure of the study information | 2013/05/07 |
| Last modified on | 2017/06/24 16:04:22 |
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Basic information
Public title
Regeneration of the jawbone using beta-tricalcium phosphate bone graft material
Acronym
Regeneration of the jawbone using beta-TCP
Scientific Title
Regeneration of the jawbone using beta-tricalcium phosphate bone graft material
Scientific Title:Acronym
Regeneration of the jawbone using beta-TCP
Region
| Japan |
Condition
Condition
Missing teeth with atrophic maxilla
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effectiveness of beta- tricalcium phosphate bone graft material especially in maxillary sinus augmentation
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
X-ray analysis of the regenerated region
Key secondary outcomes
Prognosis of dental implants installed into the regenerated site
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
beta-tricalcium phosphate
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
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Cases missing teeth and having atrophic maxilla. Dental implants will be installed them.
Key exclusion criteria
immune deficiency, uncontrolled diabetes mellitus, smoker
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiromasa Kawana |
Organization
Keio University, School of Medicine
Division name
Dept. of Dentistry and Oral Surgery
Zip code
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
03-3353-1211
kawana@keio.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiromasa Kawana |
Organization
Keio University, School of Medicine
Division name
Dept. of Dentistry and Oral Surgery
Zip code
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
03-3353-1211
Homepage URL
kawana@z6.keio.jp
Sponsor or person
Institute
Keio University, School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
None
Name of secondary funder(s)
None
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
慶應義塾大学病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 05 | Month | 07 | 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
| 2012 | Year | 12 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 12 | Month | 21 | Day |
Last follow-up date
| 2014 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2014 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2014 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2014 | Year | 04 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 05 | Month | 07 | Day |
Last modified on
| 2017 | Year | 06 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012467
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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