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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000006720
Receipt No. R000007943
Scientific Title Bone augmentation with tissue engineered bone
Date of disclosure of the study information 2011/11/14
Last modified on 2012/10/23

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Basic information
Public title Bone augmentation with tissue engineered bone
Acronym Bone augmentation with tissue engineered bone
Scientific Title Bone augmentation with tissue engineered bone
Scientific Title:Acronym Bone augmentation with tissue engineered bone
Region
Japan

Condition
Condition Atrophy of alveolar bone
Classification by specialty
Oral surgery Dental medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Evaluation of bone regeneration using tissue engineered bone which composed of autogenous mesenchymal stem cells and scaffolds
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The evaluation of safety and clinical efficacy of tissue engineered bone
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
Maneuver
Interventions/Control_1 Transplantation of tissue engineered 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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria The patients who desire to undergo bone regeneration and agree with this treatment.
Key exclusion criteria Patient who have severe complications, infectious disease, or other special conditions that is not appropriate to undergo this study.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Minoru Ueda
Organization Nagoya University Hospital
Division name Oral and Maxillofacial Surgery
Zip code
Address 65 Tsurumai-cho, Showa-ku, Nagoya, Aichi, 466-8550, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Nagoya University Hospital
Division name Oral and Maxillofacial Surgery
Zip code
Address 65 Tsurumai-cho, Showa-ku, Nagoya, Aichi, 466-8550, Japan
TEL
Homepage URL
Email

Sponsor
Institute Department of Oral and Maxillofacial Surgery, Nagoya University Hospital
Institute
Department

Funding Source
Organization The Ministry of Education,Culture,Sports,Science & Technology in Japan
Organization
Division
Category of Funding Organization
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
2011 Year 11 Month 14 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
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
2000 Year 09 Month 22 Day
Date of IRB
Anticipated trial start date
2001 Year 11 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2011 Year 11 Month 14 Day
Last modified on
2012 Year 10 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007943

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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