UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022489 |
|---|---|
| Receipt number | 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 | 2021/11/30 09:26:03 |
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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
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
s.omori.fpro@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
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
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
| 2026 | 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
| 2021 | Year | 11 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025917
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
