UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012596 |
|---|---|
| Receipt number | R000014731 |
| Scientific Title | Bone regeneration for alveolar bone regeneration using platelet rich plasma |
| Date of disclosure of the study information | 2013/12/16 |
| Last modified on | 2016/06/30 17:38:50 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Bone regeneration for alveolar bone regeneration using platelet rich plasma
Acronym
Bone regeneration for alveolar bone regeneration using platelet rich plasma
Scientific Title
Bone regeneration for alveolar bone regeneration using platelet rich plasma
Scientific Title:Acronym
Bone regeneration for alveolar bone regeneration using platelet rich plasma
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 clinically evaluate the efficacy of platelet rich plasma induced from autogenous blood for alveolar bone regeneration in the treatment of dental implant.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
At 3, 7 and 30 days after surgery, we evaluate the surgical site in accordance with 1: good, 2: normal, 3: delay.
Key secondary outcomes
1. The surgical site
At 3, 7 and 30 days after surgery, we evaluate the surgical site as followed subjects.
1: good, 2: normal, 3: delay.
2. The postoperative infection
1: good, 2: normal, 3: bad.
3. The postoperative bone formation (with radiographic examination)
The height and width measurment
4. The initial osseointegration
1: good, 2: normal, 3: poor.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
The autogenous venous blood collected from the patient to be centrifuged to concentrate the platelet rich plasma (=PRP). PRP with the autogenous bone is grafted for the surgical site.
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
The patient for alveolar bone augmentation.
Key exclusion criteria
none
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takaaki Ueno |
Organization
OsakaMedoical College
Division name
Dept. of Oral Surgery and Dentistry
Zip code
Address
2-7 Daigakumachi, Takatsuki-city, Osaka
TEL
072-683-1221
ueno@poh.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuichi Itto |
Organization
OsakaMedoical College
Division name
Dept. of Oral Surgery and Dentistry
Zip code
Address
2-7 Daigakumachi, Takatsuki-city, Osaka
TEL
072-683-1221
Homepage URL
ora059@poh.osaka-med.ac.jp
Sponsor or person
Institute
Osaka Medical College
Institute
Department
Personal name
Funding Source
Organization
Osaka Medical College
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
大阪医科大学付属病院
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 12 | Month | 16 | 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
Terminated
Date of protocol fixation
| 2012 | Year | 03 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 03 | Month | 05 | 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
| 2013 | Year | 12 | Month | 16 | Day |
Last modified on
| 2016 | Year | 06 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014731
