UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018274 |
|---|---|
| Receipt number | 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 12:14:14 |
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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
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
k-yusa@med.id.yamagata-u.ac.jp
Sponsor or person
Institute
Yamagata University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021147
