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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000005919
Receipt No. R000006994
Scientific Title Clinical trial on in situ bone tissue engineering using bioactive bone substitute for acceleration of bone regeneration in sinus floor augmentation
Date of disclosure of the study information 2011/07/11
Last modified on 2014/01/06

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Basic information
Public title Clinical trial on in situ bone tissue engineering using bioactive bone substitute for acceleration of bone regeneration in sinus floor augmentation
Acronym Clinical trial using bioactive bone substitute in sinus floor augmentation
Scientific Title Clinical trial on in situ bone tissue engineering using bioactive bone substitute for acceleration of bone regeneration in sinus floor augmentation
Scientific Title:Acronym Clinical trial using bioactive bone substitute in sinus floor augmentation
Region
Japan

Condition
Condition Atrophic maxillary alveolar bone
Classification by specialty
Oral surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Establishment of safely technique and shorter treatment period of sinus floor augmentation compared from autologous bone or synthetic apatite.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Sinus floor augmentation using FGF-2/hydroxyapatite composite is safety technique and shorten treatment period.
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 Device,equipment
Interventions/Control_1 FGF-2/Hydroxyapatite
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 The case of dental implantation in the region of maxillary molar with sinus floor augmentation
Key exclusion criteria Excluding persons are tumor bearer, cancer history, a pregnant woman an expectant mother and parity pregnancy
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Matsuno Tomonori
Organization The Nippon Dental University, School of Life Dentistry at Tokyo
Division name Depertment of Oral & Maxillofacial Surgery
Zip code
Address 1-9-20, Fujimi, Chiyoda-ku, Tokyo, Japan
TEL 03-3512-0404
Email matsunot@tky.ndu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Matsuno Tomonori
Organization The Nippon Dental University, School of Life Dentistry at Tokyo
Division name Depertment of Oral & Maxillofacial Surgery
Zip code
Address 1-9-20, Fujimi, Chiyoda-ku, Tokyo, Japan
TEL 03-3512-0404
Homepage URL
Email matsunot@tky.ndu.ac.jp

Sponsor
Institute The Nippon Dental University, School of Life Dentistry at Tokyo
Clinical study project of bone regeneration
Institute
Department

Funding Source
Organization Heisei 24 nendo The Nippon Dental University, Project study
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

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

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 日本歯科大学附属病院(東京都)

Other administrative information
Date of disclosure of the study information
2011 Year 07 Month 11 Day

Related information
URL releasing protocol http://www.tky.ndu.ac.jp/omfs/
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 No longer recruiting
Date of protocol fixation
2011 Year 07 Month 05 Day
Date of IRB
Anticipated trial start date
2011 Year 07 Month 01 Day
Last follow-up date
2014 Year 03 Month 01 Day
Date of closure to data entry
2014 Year 06 Month 01 Day
Date trial data considered complete
2015 Year 03 Month 01 Day
Date analysis concluded
2015 Year 06 Month 01 Day

Other
Other related information

Management information
Registered date
2011 Year 07 Month 05 Day
Last modified on
2014 Year 01 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006994

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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