UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008788 |
|---|---|
| Receipt number | R000010327 |
| Scientific Title | Clinical evaluation of restorative material [experior] for fixed partial prosthesis |
| Date of disclosure of the study information | 2012/08/28 |
| Last modified on | 2012/08/28 16:33:18 |
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Basic information
Public title
Clinical evaluation of restorative material [experior] for fixed partial prosthesis
Acronym
Clinical evaluation of restorative material [experior]
Scientific Title
Clinical evaluation of restorative material [experior] for fixed partial prosthesis
Scientific Title:Acronym
Clinical evaluation of restorative material [experior]
Region
| Japan |
Condition
Condition
Missing tooth
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate restorative material [experior] for fixed partial prosthesis clinically
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
inspection / attrition and fracture of teeth crown, deposition of plaque.
Dental X-ray exam.
Examination of bite force and occlusal contact
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
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
To set fixed partial prosthesis fabricated by MFR resin instead of normal prosthesis using with metal alloy
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
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients who need prosthetic treatment, who agree with this treatment, and who can keep regular maintenance after treatment.
Key exclusion criteria
Patients who cannot display themselves, who can not communicate, and who holds a full-time biomedical devices such as pacemakers.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tetsuo Ichikawa |
Organization
Tokushima University Hospital
Division name
Dentistry
Zip code
Address
770-8503, 2-50-1 Kuramoto, Tokushima, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Dentistry
Division name
Oral and maxillofacial prosthodontics
Zip code
Address
TEL
Homepage URL
tomotake.dent@tokushima-u.ac.jp
Sponsor or person
Institute
Oral and maxillofacial prosthodontics
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
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
| 2012 | Year | 08 | Month | 28 | 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
Open public recruiting
Date of protocol fixation
| 2012 | Year | 08 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 10 | Month | 15 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 08 | Month | 28 | Day |
Last modified on
| 2012 | Year | 08 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010327
