UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007503 |
|---|---|
| Receipt number | R000008854 |
| Scientific Title | Clinical evaluation of the grafting bone shape retention in jaw's born regeneration method using un-sintered HA/PLLA Composite (Super Fixsorb MX40 Mesh) in Dental Implants treatment |
| Date of disclosure of the study information | 2012/03/15 |
| Last modified on | 2012/03/14 13:21:36 |
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Basic information
Public title
Clinical evaluation of the grafting bone shape retention in jaw's born regeneration method using un-sintered HA/PLLA Composite (Super Fixsorb MX40 Mesh) in Dental Implants treatment
Acronym
Clinical evaluation of jaw's born regeneration method using un-sintered HA/PLLA Composite (Super Fixsorb MX40 Mesh) in Dental Implants treatment
Scientific Title
Clinical evaluation of the grafting bone shape retention in jaw's born regeneration method using un-sintered HA/PLLA Composite (Super Fixsorb MX40 Mesh) in Dental Implants treatment
Scientific Title:Acronym
Clinical evaluation of jaw's born regeneration method using un-sintered HA/PLLA Composite (Super Fixsorb MX40 Mesh) in Dental Implants treatment
Region
| Japan |
Condition
Condition
patient of dental implant surgery
Classification by specialty
| Oral surgery | Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The clinical evaluation of un-sintered HA/PLLA Composite (Super Fixsorb MX40 Mesh) in Dental
Implants treatment
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Survival of Dental Implant
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
Treatment
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
The using of un-sintered HA/PLLA Composite (Super Fixsorb MX40 Mesh) in Dental Implants treatment.
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
There are taken informed concent among dental implant patients at Okayama University hospital
Key exclusion criteria
(1) the patients who refsed the consent for this study
(2) the patient judged to be unsuitable for study participation by doctor in charge
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akira Sasaki |
Organization
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name
Department of Oral and Maxillofacial Surgery
Zip code
Address
2-5-1 Shikata-Cho, Kita-Ku, Okayama
TEL
086-235-6702
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroshi Mese |
Organization
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name
Department of Oral and Maxillofacial Surgery
Zip code
Address
2-5-1 Shikata-Cho, Kita-Ku, Okayama
TEL
086-235-6701
Homepage URL
hmese@md.okayama-u.ac.jp
Sponsor or person
Institute
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Institute
Department
Personal name
Funding Source
Organization
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
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
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
岡山大学病院（岡山県）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 03 | Month | 15 | 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
Preinitiation
Date of protocol fixation
| 2012 | Year | 03 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 04 | Month | 01 | 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
| 2012 | Year | 03 | Month | 14 | Day |
Last modified on
| 2012 | Year | 03 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008854
