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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000007503
Receipt No. 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

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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
Email

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
Email hmese@md.okayama-u.ac.jp

Sponsor
Institute Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008854

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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