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UMIN ID:

Recruitment status
Unique ID issued by UMIN UMIN000007327
Receipt No. R000008637
Scientific Title Estimation of autograft of human demineralized dentin matrices for mandible bone augmentation
Date of disclosure of the study information 2012/03/01
Last modified on 2016/08/24

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Basic information
Public title Estimation of autograft of human demineralized dentin matrices for mandible bone augmentation
Acronym Autograft of human dentin matrices for bone augmentation
Scientific Title Estimation of autograft of human demineralized dentin matrices for mandible bone augmentation
Scientific Title:Acronym Autograft of human dentin matrices for bone augmentation
Region
Japan

Condition
Condition patients with bone defect
Classification by specialty
Dental medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To estimate safety of autograft of dentin matrices for bone augmentation
Basic objectives2 Others
Basic objectives -Others To estimate efficacy of autograft of dentin matrices for bone augmentation
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes percentage of the cases without bone graft
Key secondary outcomes engraftment of auto dentin

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 autograft of dentin matrices
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 patients with bone defect
Key exclusion criteria poor general condition
Target sample size 28

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Haruhiko Kashiwazaki
Organization Hokkaido University
Division name Graduate School of Dental Medicine
Zip code
Address Kita-13, Nishi-7, Kita-ku, Sapporo 060-8586
TEL 011-706-4321
Email kashi@den.hokudai.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Haruhiko Kashiwazaki
Organization Hokkaido University
Division name Graduate School of Dental Medicine
Zip code
Address Kita-13, Nishi-7, Kita-ku, Sapporo 060-8586
TEL 011-706-4321
Homepage URL
Email kashi@den.hokudai.ac.jp

Sponsor
Institute Hokkaido University
Institute
Department

Funding Source
Organization Hokkaido University
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
2012 Year 03 Month 01 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
Date of protocol fixation
2012 Year 03 Month 01 Day
Date of IRB
Anticipated trial start date
2012 Year 04 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
2012 Year 02 Month 18 Day
Last modified on
2016 Year 08 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008637

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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