UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000010660
Receipt No. R000012467
Scientific Title Regeneration of the jawbone using beta-tricalcium phosphate bone graft material
Date of disclosure of the study information 2013/05/07
Last modified on 2017/06/24

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Regeneration of the jawbone using beta-tricalcium phosphate bone graft material
Acronym Regeneration of the jawbone using beta-TCP
Scientific Title Regeneration of the jawbone using beta-tricalcium phosphate bone graft material
Scientific Title:Acronym 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
1st name
Middle name
Last name Hiromasa Kawana
Organization Keio University, School of Medicine
Division name Dept. of Dentistry and Oral Surgery
Zip code
Address 35 Shinanomachi, Shinjuku-ku, Tokyo
TEL 03-3353-1211
Email kawana@keio.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiromasa Kawana
Organization Keio University, School of Medicine
Division name Dept. of Dentistry and Oral Surgery
Zip code
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

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 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

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 Completed
Date of protocol fixation
2012 Year 12 Month 21 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.