UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018457 |
|---|---|
| Receipt number | R000021327 |
| Scientific Title | Clinical assessment of CAD/CAM produced crown with hybrid resin (Sera Smart) for molar teeth. |
| Date of disclosure of the study information | 2015/08/01 |
| Last modified on | 2018/03/13 17:40:27 |
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Basic information
Public title
Clinical assessment of CAD/CAM produced crown with hybrid resin (Sera Smart) for molar teeth.
Acronym
Clinical assessment of CAD/CAM produced crown with hybrid resin (Sera Smart) for molar teeth.
Scientific Title
Clinical assessment of CAD/CAM produced crown with hybrid resin (Sera Smart) for molar teeth.
Scientific Title:Acronym
Clinical assessment of CAD/CAM produced crown with hybrid resin (Sera Smart) for molar teeth.
Region
| Japan |
Condition
Condition
Caries of molar tooth
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is estimate the clinical validity of CAD/CAM produced hybrid resin crown for molar teeth by follow up.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
crack/fracture of crown, dislocated, condition of occlusal contact, condition of occlusal surface of crown/antagonistic teeth, crown color, plaque build-up, condition of interproximal contact, necessity of retreatment, pain, second caries
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
| Other |
Interventions/Control_1
application of CAD/CAM hybrid resin crown for molar teeth
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
treatment by crown for molar teeth, sufficient occlusal clearance, antagonistic teeth are existed
Key exclusion criteria
abutment tooth is infected by periodontal disease/apical periodontitis, clasped tooth, bruxism
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hitoshi Abekura |
Organization
Hiroshima University Hospital
Division name
Department of Prosthetic Dentistry
Zip code
Address
2-3,Kasumi 1-chome, Minami-Ku Hiroshima, Japan
TEL
082-257-5682
abekura@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hironori Tsuka |
Organization
Hiroshima University Hospital
Division name
Department of Prosthetic Dentistry
Zip code
Address
2-3,Kasumi 1-chome, Minami-Ku Hiroshima, Japan
TEL
082-257-5682
Homepage URL
tsuka311@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University Hospital
Institute
Department
Personal name
Funding Source
Organization
GC Corporation
Organization
Division
Category of Funding Organization
Profit organization
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
| 2015 | Year | 08 | Month | 01 | 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
| 2015 | Year | 01 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 06 | Month | 06 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2018 | Year | 03 | Month | 09 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 07 | Month | 28 | Day |
Last modified on
| 2018 | Year | 03 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021327
