UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018953 |
|---|---|
| Receipt number | R000021930 |
| Scientific Title | The safety analysis of dental implant immobilized conditioned medium derived from autologous conditioned medium. |
| Date of disclosure of the study information | 2015/09/09 |
| Last modified on | 2016/08/06 16:02:04 |
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Basic information
Public title
The safety analysis of dental implant immobilized conditioned medium derived from autologous conditioned medium.
Acronym
The safety analysis of dental implant immobilized conditioned medium.
Scientific Title
The safety analysis of dental implant immobilized conditioned medium derived from autologous conditioned medium.
Scientific Title:Acronym
The safety analysis of dental implant immobilized conditioned medium.
Region
| Japan |
Condition
Condition
missing teeth
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To ensure the safety of dental implant that is immobilized conditioned medium.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Xray, WBC, RBC, PLT, GTP, GOP, LDH, IgA, clinical observation
1,2 weeks, 1,3,6,12month after implantation
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
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
The insert the dental implant that is ibimmobilized conditioned medium. One time.
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 that want to treat the denal implant for missing teeth.
The patient that has the bone quantity to insert the 13mm length implant.
Key exclusion criteria
The patient that don't have the enough bone to insert the implant.
The patient with the dependency of a patient, the drug which an operation by the local anesthesia has an impossible serious whole body disease and the alcohol, an oral hygiene state are bad, and improvement excludes the patient that it is not admitted from this study after the instruction. In addition, there is the past of the malignant tumor, and the radiotherapy that top and bottom jawbone is in the irradiation range, the patient with the past of the chemotherapy exclude it. In addition, the patient having HIV, HCV, HBV, an infectious disease of the HTLV excludes it.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hibi Hideharu |
Organization
Nagoya University Hospital
Division name
Oral and Maxillifacial Surgery
Zip code
Address
Tsurumai-cho 65 Showa-ku Nagoya-city Aichi
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
Nagoya University Hospital
Division name
Oral and Maxillifacial Surgery
Zip code
Address
65 Showa-ku Nagoya-city Aichi
TEL
052-744-2348
Homepage URL
t-shuhei@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University Hospital
Institute
Department
Personal name
Funding Source
Organization
Nagoya University Hospital
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 | 09 | Month | 09 | 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 | 09 | Month | 09 | 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=R000021930
