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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000022489
Receipt No. R000025917
Scientific Title Clinical evaluation of ceramic crown restoration with press ceraimcs (Initial LiSi Press) for premolar and molar teeth
Date of disclosure of the study information 2016/09/01
Last modified on 2019/05/30

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Basic information
Public title Clinical evaluation of ceramic crown restoration with press ceraimcs (Initial LiSi Press) for premolar and molar teeth
Acronym Clinical evaluation of ceramic crown restoration with press ceramics
Scientific Title Clinical evaluation of ceramic crown restoration with press ceraimcs (Initial LiSi Press) for premolar and molar teeth
Scientific Title:Acronym Clinical evaluation of ceramic crown restoration with press ceramics
Region
Japan

Condition
Condition caries
Classification by specialty
Dental medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy of ceramic crown with press ceramics for premolar and molar crown.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes crack/fracture of crown, deslocated, 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 Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Ceramic crown with press ceramics for premolar and molar crown
Interventions/Control_2 Ceramic crown with press ceramics for premolar and molar crown
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 Patient treat with single crown restoration by caries
Key exclusion criteria Bruxism
Abutment tooth for removable partial denture
Low-height of abutment tooth
Target sample size 60

Research contact person
Name of lead principal investigator
1st name Hiroyuki
Middle name
Last name Miura
Organization Tokyo Medical and Dental University
Division name Graduate school, Fixed Prosthodontics
Zip code 13-8549
Address 1-5-45, Yushima, Bunkyo-ku, Tokyo 113-8549, Japan
TEL 03-5803-5522
Email h.miura.fpro@tmd.ac.jp

Public contact
Name of contact person
1st name Satoshi
Middle name
Last name Omori
Organization Tokyo Medical and Dental University
Division name Graduate school, Fixed Prosthodontics
Zip code 13-8549
Address 1-5-45, Yushima, Bunkyo-ku, Tokyo 113-8549, Japan
TEL 03-5803-5522
Homepage URL
Email s.omori.fpro@tmd.ac.jp

Sponsor
Institute Tokyo Medical and Dental University
Institute
Department

Funding Source
Organization Tokyo Medical and Dental University
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 Tokyo Medical and Dental University
Address 1-5-45, Yushima, Bunkyo-ku, Tokyo 113-8549, Japan
Tel 03-5803-5522
Email s.omori.fpro@tmd.ac.jp

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
2016 Year 09 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 Enrolling by invitation
Date of protocol fixation
2016 Year 03 Month 01 Day
Date of IRB
2016 Year 09 Month 15 Day
Anticipated trial start date
2016 Year 09 Month 15 Day
Last follow-up date
2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 05 Month 27 Day
Last modified on
2019 Year 05 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025917

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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