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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Open public recruiting |
Unique ID issued by UMIN | UMIN000032549 |
Receipt No. | 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 |
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 |
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Condition | ||
Condition | dental implant | |
Classification by specialty |
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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 |
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Interventions/Control_1 | Guided bone regeneration covered with titanium mesh membrane | |
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Eligibility | ||||
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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 |
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Name of lead principal investigator |
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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 |
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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 | |
Institute | Medicine Osaka Medical College |
Institute | |
Department |
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) | |
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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) |
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Date of disclosure of the study information |
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Related information | |
URL releasing protocol | |
Publication of results | Partially published |
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Progress | |||||||
Recruitment status | Open public recruiting | ||||||
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037124 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |