UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Regeneration of the jawbone using beta-tricalcium phosphate bone graft material
Title of the study (Brief title)	Regeneration of the jawbone using beta-TCP
Region	Japan

Condition
Condition	Missing teeth with atrophic maxilla
Classification by specialty	Dental medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the effectiveness of beta- tricalcium phosphate bone graft material especially in maxillary sinus augmentation
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	X-ray analysis of the regenerated region
Key secondary outcomes	Prognosis of dental implants installed into the regenerated site

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	beta-tricalcium phosphate
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	70 years-old >=
Gender	Male and Female
Key inclusion criteria	Cases missing teeth and having atrophic maxilla. Dental implants will be installed them.
Key exclusion criteria	immune deficiency, uncontrolled diabetes mellitus, smoker
Target sample size	100

Research contact person
Name of lead principal investigator	Hiromasa Kawana
Organization	Keio University, School of Medicine
Division name	Dept. of Dentistry and Oral Surgery
Address	35 Shinanomachi, Shinjuku-ku, Tokyo
TEL	03-3353-1211
Email	kawana@keio.jp

Public contact
Name of contact person	Hiromasa Kawana
Organization	Keio University, School of Medicine
Division name	Dept. of Dentistry and Oral Surgery
Address	35 Shinanomachi, Shinjuku-ku, Tokyo
TEL	03-3353-1211
Homepage URL
Email	kawana@z6.keio.jp

Sponsor
Institute	Keio University, School of Medicine
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	None
Name of secondary funｄer(s)	None

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	慶應義塾大学病院（東京都）

Other administrative information
Date of disclosure of the study information	2013 Year 05 Month 07 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 12 Month 21 Day
Anticipated trial start date	2012 Year 12 Month 21 Day
Last follow-up date	2014 Year 03 Month 31 Day
Date of closure to data entry	2014 Year 03 Month 31 Day
Date trial data considered complete	2014 Year 03 Month 31 Day
Date analysis concluded	2014 Year 04 Month 30 Day

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

Management information
Registered date	2013 Year 05 Month 07 Day
Last modified on	2017 Year 06 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012467