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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000018274
Receipt No. R000021147
Scientific Title Acceleration of bone healing with Platelet-Rich Plasma of bone defect of jaw.
Date of disclosure of the study information 2015/07/13
Last modified on 2015/07/11

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Basic information
Public title Acceleration of bone healing with Platelet-Rich Plasma of bone defect of jaw.
Acronym Acceleration of bone healing with Platelet-Rich Plasma of bone defect of jaw.
Scientific Title Acceleration of bone healing with Platelet-Rich Plasma of bone defect of jaw.
Scientific Title:Acronym Acceleration of bone healing with Platelet-Rich Plasma of bone defect of jaw.
Region
Japan

Condition
Condition bone defect
Classification by specialty
Oral surgery Dental medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to evaluate the effect of platelet rich plasma for bone formation and wound healing.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Evaluate postoperative bone formation by radiographic examination at 3,6,12 month after surgery
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 Platelet rich plasma which purified from the autogenous venous blood is grafted into the bone defect.
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
15 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria The patient with jaw bone defect
Key exclusion criteria none
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Mitsuyoshi Iino
Organization Yamagata University
Division name Department of Dentistry, Oral and Maxillofacial Plastic and Reconstructive Surgery
Zip code
Address 2-2-2 Iida-Nishi, Yamagata, Yamagata
TEL 023-628-5413
Email m-iino@med.id.yamagata-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kazuyuki Yusa
Organization Yamagata University
Division name Department of Dentistry, Oral and Maxillofacial Plastic and Reconstructive Surgery
Zip code
Address 2-2-2 Iida-Nishi, Yamagata, Yamagata
TEL 023-628-5413
Homepage URL
Email k-yusa@med.id.yamagata-u.ac.jp

Sponsor
Institute Yamagata University
Institute
Department

Funding Source
Organization Yamagata University
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
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
2015 Year 07 Month 13 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 Preinitiation
Date of protocol fixation
2015 Year 04 Month 20 Day
Date of IRB
Anticipated trial start date
2015 Year 07 Month 13 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
2015 Year 07 Month 11 Day
Last modified on
2015 Year 07 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021147

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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