UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000041012
Receipt number R000046822
Scientific Title assessment of efficacy of GC membrane on guided bone regeneration for bone augmentation
Date of disclosure of the study information 2020/07/06
Last modified on 2020/07/06 13:32:44

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Basic information

Public title

assessment of efficacy of GC membrane on guided bone regeneration for bone augmentation

Acronym

assessment of efficacy of GC membrane on guided bone regeneration for bone augmentation

Scientific Title

assessment of efficacy of GC membrane on guided bone regeneration for bone augmentation

Scientific Title:Acronym

assessment of efficacy of GC membrane on guided bone regeneration

Region

Japan


Condition

Condition

insufficient alveolar bone for dental implantation

Classification by specialty

Dental medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

to assess the efficacy of GC membrane, which has been applied for guided tissue regeneration (GTR), on guided bone regeneration (GBR)

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

regenerated bone volume

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

Historical

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

bone augmentation

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

90 years-old >=

Gender

Male and Female

Key inclusion criteria

insufficient bone volume for dental implantation
informed consent
routine admission

Key exclusion criteria

smoker
abused alcohol
uncontrolled DM, HT and systemic disease
BP

Target sample size

30


Research contact person

Name of lead principal investigator

1st name Izumi
Middle name
Last name Asahinna

Organization

Nagasaki University

Division name

Dep. Regenerative Oral Surgery

Zip code

852-8588

Address

1-7-1

TEL

095-819-7704

Email

asahinna@nagasaki-u.ac.jp


Public contact

Name of contact person

1st name Seigo
Middle name
Last name Ohba

Organization

Nagasaki University

Division name

Dep. Regenerative Oral Surgery

Zip code

852-8588

Address

1-7-1 Sakamoto, Nagasaki

TEL

095-819-7704

Homepage URL


Email

sohba@nagasaki-u.a.jp


Sponsor or person

Institute

Nagasaki University

Institute

Department

Personal name



Funding Source

Organization

Nagasaki University

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

nagasaki Universituy

Address

1-7-1 Sakamoto, Nagasaki

Tel

095-819-7704

Email

sohba@nagasaki-u.ac.jp


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



Other administrative information

Date of disclosure of the study information

2020 Year 07 Month 06 Day


Related information

URL releasing protocol

https://link.springer.com/article/10.1007/s10266-018-0349-2

Publication of results

Published


Result

URL related to results and publications

https://link.springer.com/article/10.1007/s10266-018-0349-2

Number of participants that the trial has enrolled

18

Results

the effect of GC membrane on GBR was confirmed. in addition, no adverse event was found.

Results date posted

2020 Year 07 Month 06 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

patients who were required GBR simultaneously with dental implantation. Patients who was under uncontrolled systemic disease were excluded.

Participant flow

routine treatment was performed for all patients after observation.

Adverse events

nothing

Outcome measures

augmented bone volume.

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2014 Year 04 Month 01 Day

Date of IRB

2014 Year 05 Month 30 Day

Anticipated trial start date

2014 Year 06 Month 01 Day

Last follow-up date

2016 Year 07 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2020 Year 07 Month 06 Day

Last modified on

2020 Year 07 Month 06 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046822


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name