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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

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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
Email 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
Email 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)
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 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
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


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