UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036234 |
|---|---|
| Receipt number | R000040996 |
| Scientific Title | Exploratory clinical study to evaluate the safety of Platelet rich plasma transplantation with artificial bone graft material for sinus floor augmentation. |
| Date of disclosure of the study information | 2019/03/17 |
| Last modified on | 2019/03/19 09:16:41 |
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Basic information
Public title
Exploratory clinical study to evaluate the safety of Platelet rich plasma transplantation with artificial bone graft material for sinus floor augmentation.
Acronym
Platelet rich plasma transplantation with artificial bone graft material for sinus floor augmentation.
Scientific Title
Exploratory clinical study to evaluate the safety of Platelet rich plasma transplantation with artificial bone graft material for sinus floor augmentation.
Scientific Title:Acronym
Platelet rich plasma transplantation with artificial bone graft material for sinus floor augmentation.
Region
| Japan |
Condition
Condition
Atrophic maxillary alveolar bone
Classification by specialty
| Oral surgery | Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the safety of Platelet rich plasma transplantation with artificial bone graft
material for sinus floor augmentation
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Safety
Key secondary outcomes
Scientific validity
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
| Other |
Interventions/Control_1
Platelet rich plasma transplantation
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
A patient MUST:
1) Have missing tooth in the maxillary posterior region.
2) Require dental implant treatment at missing tooth site.
3) Require sinus floor augmentation (socket lift) at the dental implant placement.
4) Have good systemic condition.
5) Number of platelet is over 1x10E5 /microliter.
6) 20 years and older.
7) Other,the investigator believes makes him/her suitable for participation in this clinical study.
Key exclusion criteria
Patient MUST NOT:
1) Have a history of Complicate malignant tumor.
2) Have an abnormal gingival proliferation or having a history of abnormal gingival proliferation.
3) Suspected of oral malignant tumor or precancerous lesion.
4) Under 20 years of old.
5) Have anti-coagulant or anti-platelet medications, or have a bleeding disorders.
6) Pregnancy, breastfeeding, or possibility of pregnancy.
7) Other,the investigator believes makes him/her unsuitable for participation in the clinical study.
Target sample size
2
Research contact person
Name of lead principal investigator
| 1st name | Morikuni |
| Middle name | |
| Last name | Tobita |
Organization
Juntendo Hospital, Juntendo university school of medicine
Division name
Department of Oral and Maxillofacial Surgery
Zip code
113-8431
Address
3-1-3, Hongo, Bunkyo-ku, Tokyo, 113-8431, Japan
TEL
03-3813-3111
mtobita@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Morikuni |
| Middle name | |
| Last name | Tobita |
Organization
Juntendo Hospital, Juntendo university school of medicine
Division name
Department of Oral and Maxillofacial Surgery
Zip code
113-8431
Address
3-1-3, Hongo, Bunkyo-ku, Tokyo, 113-8431, Japan
TEL
03-3813-3111
Homepage URL
mtobita@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Review Board of Juntendo University Faculty of Medicine
Address
2-1-1, Hongo, Bunkyo-ku, Tokyo, Japan
Tel
03-3813-3111
rinri@juntendo.ac.jp
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
順天堂大学附属順天堂医院（東京都）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 03 | Month | 17 | 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
Open public recruiting
Date of protocol fixation
| 2019 | Year | 03 | Month | 14 | Day |
Date of IRB
| 2019 | Year | 03 | Month | 18 | Day |
Anticipated trial start date
| 2019 | Year | 03 | Month | 18 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 03 | Month | 17 | Day |
Last modified on
| 2019 | Year | 03 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040996
