UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018859 |
|---|---|
| Receipt number | R000010877 |
| Scientific Title | The safety test of dental implant that was immobilized growth factor derived from self-bone marrow stromal cell. |
| Date of disclosure of the study information | 2017/12/31 |
| Last modified on | 2016/08/06 16:02:20 |
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Basic information
Public title
The safety test of dental implant that was immobilized growth factor derived from self-bone marrow stromal cell.
Acronym
The safety test of CM immobilized implant.
Scientific Title
The safety test of dental implant that was immobilized growth factor derived from self-bone marrow stromal cell.
Scientific Title:Acronym
The safety test of CM immobilized implant.
Region
| Japan |
Condition
Condition
Missing teeth
Classification by specialty
| Oral surgery | Dental medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The safety test of conditioned medium immobilized implant.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Symptom of allegy by cell derived conditioned medium.
1 week before implantation and immediately after implant surgery.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
The insertion of dental implant. The observation of dental implant.
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 growth og jaw is finished.
Key exclusion criteria
a.The bone volume is abundance to insert the dental implant.
b. general condition is good
c. alcohol, drug dependence patient
d. oral hygiene is poor
e. irradiated jaw
f. lidocaine hydrochloride is incompatible drugs.
g. metabolic bone disease
h. The patient intake the bisphosphonete drug.
i. pregnant
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | HIBI Hideharu |
Organization
The Nagoya University
Division name
Oral and Maxillofacial surgery
Zip code
Address
65 Tsurumai, Showa-ku, Nagoya city
TEL
052-744-2348
hibihi@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | TSUCHIYA Shuhei |
Organization
The Nagoya University Hospital
Division name
Oral and Maxillofacial Surgery
Zip code
Address
65 Tsurumai, Showa-ku, Nagoya city
TEL
052-744-2348
Homepage URL
http://www.med.nagoya-u.ac.jp/medical/6391/6408/gakuganmengekagaku_soshakushougaiseigyogaku.html
t-shuhei@med.nagoyoa-u.ac.jp
Sponsor or person
Institute
The Nagoya University Hospital
Institute
Department
Personal name
Funding Source
Organization
N/A
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
| 2017 | Year | 12 | Month | 31 | 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
Completed
Date of protocol fixation
| 2012 | Year | 12 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 12 | Month | 06 | Day |
Last follow-up date
| 2015 | Year | 12 | Month | 05 | Day |
Date of closure to data entry
| 2015 | Year | 12 | Month | 05 | Day |
Date trial data considered complete
| 2015 | Year | 12 | Month | 05 | Day |
Date analysis concluded
| 2015 | Year | 12 | Month | 05 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 08 | Month | 31 | Day |
Last modified on
| 2016 | Year | 08 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010877
