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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000002123
Receipt No. R000002590
Scientific Title Long-term of Clinical Trial of Composite Resin Core with Fiber Post
Date of disclosure of the study information 2009/06/26
Last modified on 2009/06/26

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Basic information
Public title Long-term of Clinical Trial of Composite Resin Core with Fiber Post
Acronym Long-term of Clinical Trial of Composite Resin Core with Fiber Post
Scientific Title Long-term of Clinical Trial of Composite Resin Core with Fiber Post
Scientific Title:Acronym Long-term of Clinical Trial of Composite Resin Core with Fiber Post
Region
Japan

Condition
Condition Fixed Prosthodontics, Dentistry
Classification by specialty
Dental medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the clinical performance of composite resin core with fiber post
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase

Assessment
Primary outcomes Check every three month for first year, and then every one year to third years.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Composite resin core with fiber post
Interventions/Control_2 Cast metal post and core
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 Patient who treated foundation restoration to maxillary/mundibullary anterior/premolar teeth
Key exclusion criteria Patient who treated difficulty for handicapped.
Patient who can not understand purport of research.
Patient who can not agree with this research.
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shunji Fukushima
Organization Tsurumi University School of Dental Medicine
Division name Department of Fixed Prosthodontics
Zip code
Address 2-1-3 Tsurumi Yokohama Kanagawa, JAPAN
TEL 045-580-8411
Email

Public contact
Name of contact person
1st name
Middle name
Last name Yuji Tsubota
Organization Tsurumi University School of Dental Medicine
Division name Department of Fixed Prosthodontics
Zip code
Address 2-1-3 Tsurumi Yokohama Kanagawa, JAPAN
TEL 045-580-8555
Homepage URL
Email tsubota-y@tsurumi-u.ac.jp

Sponsor
Institute Department of Fixed Prosthodontics, Tsurumi University School of Dental Medicine
Institute
Department

Funding Source
Organization Japanese Association for Dental Science
Organization
Division
Category of Funding Organization Non profit foundation
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

Other administrative information
Date of disclosure of the study information
2009 Year 06 Month 26 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 Preinitiation
Date of protocol fixation
2009 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2009 Year 08 Month 01 Day
Last follow-up date
2012 Year 08 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 06 Month 26 Day
Last modified on
2009 Year 06 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002590

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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