UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015206 |
|---|---|
| Receipt number | R000017680 |
| Scientific Title | Study of alveolar bone regeneration treatment with a Tailor-made titanium mesh to the alveolar bone defects |
| Date of disclosure of the study information | 2014/09/19 |
| Last modified on | 2014/09/19 11:20:18 |
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Basic information
Public title
Study of alveolar bone regeneration treatment with a Tailor-made titanium mesh to the alveolar bone defects
Acronym
Clinical evaluation of the GBR treatment with a custom-made titanium mesh
Scientific Title
Study of alveolar bone regeneration treatment with a Tailor-made titanium mesh to the alveolar bone defects
Scientific Title:Acronym
Clinical evaluation of the GBR treatment with a custom-made titanium mesh
Region
| Japan |
Condition
Condition
Alveolar bone resorption
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Alveolar bone reconstruction
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
a increase rate of mastication function
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Custom-made titanium mesh
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. blood pressure is controlled to less than 140/90, 2, After receiving a sufficient explanation, on a thorough understanding, document consent voluntary patient himself was obtained
Key exclusion criteria
1. Patients (HbA1C>6.5, BS>110) of diabetes.
2. Patients with experience of injection or oral formulation of BP.
3. Patients with metabolic bone diseases.
4. Patients of childbearing potential or pregnant women.
5. Patients with renal failure (Cr> 1.5) and hepatic failure(AST> 100, ALT> 100) arrhythmias and heart failure.
6. Patients with constitution of allergic symptoms.
7. The intradermal reaction positive example by those reservations.
8. Patients whome doctor determines inappropriate to test.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | MORI Yoshihide |
Organization
Section of Oral & Maxillofacial Surgery,Division of Maxillofacial Diagnostic and Surgical Sciences
Division name
Dental Science, Kyushu University
Zip code
Address
Maidashi 3-1-1, Higashiku, Fukuoka
TEL
092-642-6452
y-mori@dent.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | OTAWA Naruto |
Organization
Section of Oral & Maxillofacial Surgery
Division name
Dental Science, Kyushu University
Zip code
Address
Maidashi 3-1-1, Higashiku, Fukuoka
TEL
092-642-6452
Homepage URL
otawa@dent.kyushu-u.ac.jp
Sponsor or person
Institute
Faculty of Dental Science, Kyushu University, Section of Oral & Maxillofacial Surgery,Division of Maxillofacial Diagnostic and Surgical Sciences
Institute
Department
Personal name
Funding Source
Organization
Amada foundation
Organization
Division
Category of Funding Organization
Non profit foundation
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
| 2014 | Year | 09 | Month | 19 | 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
Open public recruiting
Date of protocol fixation
| 2014 | Year | 07 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 07 | Month | 16 | 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
| 2014 | Year | 09 | Month | 19 | Day |
Last modified on
| 2014 | Year | 09 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017680
