UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032549 |
|---|---|
| Receipt number | R000037124 |
| Scientific Title | Reconstruction of the Gnathic Bone Using Guided Bone Regeneration with Selective Laser Melting Titanium Mesh Membrane |
| Date of disclosure of the study information | 2020/05/12 |
| Last modified on | 2018/05/11 00:09:52 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Reconstruction of the Gnathic Bone Using Guided Bone Regeneration with Selective Laser Melting Titanium Mesh Membrane
Acronym
Guided Bone Regeneration with Selective Laser Melting Titanium Mesh Membrane
Scientific Title
Reconstruction of the Gnathic Bone Using Guided Bone Regeneration with Selective Laser Melting Titanium Mesh Membrane
Scientific Title:Acronym
Guided Bone Regeneration with Selective Laser Melting Titanium Mesh Membrane
Region
| Japan |
Condition
Condition
dental implant
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Guided bone regeneration is used to supplement bone defects during dental implant treatment. With this technique, the area filled with bone prosthetic material is covered with an artificial or titanium mesh membrane, which must be manually adapted to the bone defect during the procedure before being fixed in place. Selective laser melting can be used to pre-adapt the titanium mesh based on preoperative computed tomography data. This method enables shorter surgery times compared with conventional titanium mesh methods, as well as regeneration of an ideal alveolar bone shape. Here, we present two cases of bone augmentation using the selective laser melting titanium method The postoperative course was without complications in both cases; neither patient experienced mesh exposure or infection during healing. Selective laser melting titanium mesh method should be considered as a new and effective bone augmentation method.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
evaluate a postoperative bone form
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 |
Interventions/Control_1
Guided bone regeneration covered with titanium mesh membrane
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
The patient who accepts a bone defect in dental implant treatment
Key exclusion criteria
minor
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | kazuya inoue |
Organization
Medicine Osaka Medical College
Division name
Department of Dentistry and Oral Surgery
Zip code
Address
2-7 Daigaku-machi, Takatsuki-city, Osaka 569-8686, Japan
TEL
072-683-1221
ora092@osaka-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | office of research |
Organization
Medicine Osaka Medical College
Division name
office of research
Zip code
Address
2-7 Daigaku-machi, Takatsuki-city, Osaka
TEL
072-683-6333
Homepage URL
rco000@osaka-med.ac.jp
Sponsor or person
Institute
Medicine Osaka Medical College
Institute
Department
Personal name
Funding Source
Organization
Medicine Osaka Medical College
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Osaka Yakin Kogyo Co., Ltd
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
大阪医科大学（大阪府）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 05 | Month | 12 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
| 2018 | Year | 02 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 03 | Month | 02 | 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
| 2018 | Year | 05 | Month | 11 | Day |
Last modified on
| 2018 | Year | 05 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037124
