UMIN-CTR Clinical Trial

Basic information
Public title	Clinical study of bone filling materials Osferion and BioOss for bone gain in implant surgery and bone regeneration in bone defects
Acronym	Clinical study of bone filling materials Osferion and BioOss for bone gain in implant surgery and bone regeneration in bone defects
Scientific Title	Clinical study of bone filling materials Osferion and BioOss for bone gain in implant surgery and bone regeneration in bone defects
Scientific Title:Acronym	Clinical study of bone filling materials Osferion and BioOss for bone gain in implant surgery and bone regeneration in bone defects
Region	Japan

Condition
Condition	missing teeth
Classification by specialty	Dental medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Study the bone regeneration ability of cistern bone and jaw bone by bone filling material.
Basic objectives2	Others
Basic objectives -Others	biological safty
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	bone augmentation
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	Medicine
Interventions/Control_1	artificial bone
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	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients who are judged to need to be compensated for bone defects with artificial bone
Key exclusion criteria	Patients who are judged to be unnecessary to compensate for bone defects with artificial bone
Target sample size	30

Research contact person
Name of lead principal investigator	1st name inoue Middle name Last name kazuya
Organization	osaka medical and Pharmaceutical University
Division name	oral surgery
Zip code	569-8686
Address	osaka. takatsuki
TEL	0726831221
Email	kazuya.inoue@ompu.ac.jp

Public contact
Name of contact person	1st name inoue Middle name Last name kazuya
Organization	osaka medical and Pharmaceutical University
Division name	oral surgery
Zip code	569-8686
Address	takatsuki,osaka
TEL	0726831221
Homepage URL
Email	kazuya.inoue@ompu.ac.jp

Sponsor
Institute	osaka medical and Pharmaceutical University
Institute
Department

Funding Source
Organization	none
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	Faculty of oral surgery.osaka medical and Pharmaceutical University
Address	takatsuki,osaka
Tel	0726831221
Email	kazuya.inoue@ompu.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	2022 Year 04 Month 29 Day

Related information
URL releasing protocol
Publication of results	Unpublished

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	2013 Year 07 Month 25 Day
Date of IRB	2013 Year 07 Month 25 Day
Anticipated trial start date	2020 Year 04 Month 01 Day
Last follow-up date	2024 Year 03 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	2022 Year 04 Month 28 Day
Last modified on	2022 Year 04 Month 28 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054305