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

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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 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


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

Value
https://center6.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