UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Sinus Floor Elevation Using Terufill Bone Substitute.
Title of the study (Brief title)	Sinus Floor Elevation Using Terufill Bone Substitute.
Region	Japan

Condition
Condition	Severe Alveolar Bone Resorption
Classification by specialty	Dental medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Success of Implant Treatment
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Implant Osseointegration (six months after surgery)
Key secondary outcomes	Adverse Event

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	Applying Terufill for Sinus Floor Elevation
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	18 years-old <=
Age-upper limit	75 years-old >=
Gender	Male and Female
Key inclusion criteria	From 18 to 75 years-old patients having severe alveolar bone resorption who are adaptable for implant treatment.
Key exclusion criteria	1) immune deficiency 2) uncontrolled diabetes 3) under 17 years-old or over 76 years-old
Target sample size	10

Research contact person
Name of lead principal investigator	Kawana Hiromasa
Organization	Keio University School of Medicine
Division name	Division of Dentistry and Oral Surgery
Address	35 Shinanomachi, Shinjuku-ku, Tokyo
TEL	03-5363-3831
Email	kawana@keio.jp

Public contact
Name of contact person	Miyashita Hidetaka
Organization	Keio University School of Medicine
Division name	Division of Dentistry and Oral Surgery
Address	35 Shinanomachi, Shinjuku-ku, Tokyo
TEL	03-5363-3831
Homepage URL
Email	miyashita@keio.jp

Sponsor
Institute	Keio University
Institute
Department

Funding Source
Organization	Self funding
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2017 Year 02 Month 01 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2016 Year 11 Month 14 Day
Anticipated trial start date	2017 Year 02 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 01 Month 21 Day
Last modified on	2019 Year 03 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000029660