UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002123 |
|---|---|
| Receipt number | 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 18:45:05 |
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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
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
tsubota-y@tsurumi-u.ac.jp
Sponsor or person
Institute
Department of Fixed Prosthodontics, Tsurumi University School of Dental Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002590
