UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005919 |
|---|---|
| Receipt number | R000006994 |
| Scientific Title | Clinical trial on in situ bone tissue engineering using bioactive bone substitute for acceleration of bone regeneration in sinus floor augmentation |
| Date of disclosure of the study information | 2011/07/11 |
| Last modified on | 2014/01/06 12:08:51 |
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Basic information
Public title
Clinical trial on in situ bone tissue engineering using bioactive bone substitute for acceleration of bone regeneration in sinus floor augmentation
Acronym
Clinical trial using bioactive bone substitute in sinus floor augmentation
Scientific Title
Clinical trial on in situ bone tissue engineering using bioactive bone substitute for acceleration of bone regeneration in sinus floor augmentation
Scientific Title:Acronym
Clinical trial using bioactive bone substitute in sinus floor augmentation
Region
| Japan |
Condition
Condition
Atrophic maxillary alveolar bone
Classification by specialty
| Oral surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Establishment of safely technique and shorter treatment period of sinus floor augmentation compared from autologous bone or synthetic apatite.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Sinus floor augmentation using FGF-2/hydroxyapatite composite is safety technique and shorten treatment period.
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 | Device,equipment |
Interventions/Control_1
FGF-2/Hydroxyapatite
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
The case of dental implantation in the region of maxillary molar with sinus floor augmentation
Key exclusion criteria
Excluding persons are tumor bearer, cancer history, a pregnant woman an expectant mother and parity pregnancy
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Matsuno Tomonori |
Organization
The Nippon Dental University, School of Life Dentistry at Tokyo
Division name
Depertment of Oral & Maxillofacial Surgery
Zip code
Address
1-9-20, Fujimi, Chiyoda-ku, Tokyo, Japan
TEL
03-3512-0404
matsunot@tky.ndu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Matsuno Tomonori |
Organization
The Nippon Dental University, School of Life Dentistry at Tokyo
Division name
Depertment of Oral & Maxillofacial Surgery
Zip code
Address
1-9-20, Fujimi, Chiyoda-ku, Tokyo, Japan
TEL
03-3512-0404
Homepage URL
matsunot@tky.ndu.ac.jp
Sponsor or person
Institute
The Nippon Dental University, School of Life Dentistry at Tokyo
Clinical study project of bone regeneration
Institute
Department
Personal name
Funding Source
Organization
Heisei 24 nendo The Nippon Dental University, Project study
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
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
日本歯科大学附属病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 07 | Month | 11 | Day |
Related information
URL releasing protocol
http://www.tky.ndu.ac.jp/omfs/
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
No longer recruiting
Date of protocol fixation
| 2011 | Year | 07 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2014 | Year | 06 | Month | 01 | Day |
Date trial data considered complete
| 2015 | Year | 03 | Month | 01 | Day |
Date analysis concluded
| 2015 | Year | 06 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 07 | Month | 05 | Day |
Last modified on
| 2014 | Year | 01 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006994
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
