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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000018953
Receipt No. 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

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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
Email 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
Email t-shuhei@med.nagoya-u.ac.jp

Sponsor
Institute Nagoya University Hospital
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021930

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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