UMIN-CTR Clinical Trial

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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