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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000018457
Receipt No. 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

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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
Email 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
Email tsuka311@hiroshima-u.ac.jp

Sponsor
Institute Hiroshima University Hospital
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021327

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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