UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018647 |
|---|---|
| Receipt number | R000021547 |
| Scientific Title | Clinical evaluation of the molar crown with the CAD/CAM hybrid resin (KATANA AVENCIA) |
| Date of disclosure of the study information | 2015/09/01 |
| Last modified on | 2019/08/15 18:39:37 |
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Basic information
Public title
Clinical evaluation of the molar crown with the CAD/CAM hybrid resin (KATANA AVENCIA)
Acronym
The molar crown made by KATANA AVENCIA
Scientific Title
Clinical evaluation of the molar crown with the CAD/CAM hybrid resin (KATANA AVENCIA)
Scientific Title:Acronym
The molar crown made by KATANA AVENCIA
Region
| Japan |
Condition
Condition
Caries
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The molar crown is made by the CAD/CAM hybrid resin and followed it up to examine the clinical validity.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Clinical course of the crown and surround tissue
1) Objective investigation
(1) Evaluation of the crown (abutment tooth)
(2) Evaluation of opposing tooth
2) Subjective investigation (evaluation by patient)
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 71 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Patient diagnosed as needing a single crown prosthetic treatmnet for a molar
Key exclusion criteria
1) Patient who has bruxism
2) Not enough prepalation thickness
3) Abutment tooth of the denture
4) Occlusal vertical dimension is insufficient
5) Absence of antagonistic tooth
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Hirofumi |
| Middle name | |
| Last name | YATANI |
Organization
Osaka University Graduate School of Dentistry
Division name
Department of Fixed Prothodontics
Zip code
565-0871
Address
1-8, Yamadaoka, Suita city, Osaka, JAPAN, 565-0871
TEL
06-6879-2946
yatani@dent.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Atsushi |
| Middle name | |
| Last name | MINE |
Organization
Osaka University Graduate School of Dentistry
Division name
Department of Fixed Prothodontics
Zip code
565-0871
Address
1-8, Yamadaoka, Suita city, Osaka, JAPAN, 565-0871
TEL
06-6879-2946
Homepage URL
amine@md.okayama-u.ac.jp
Sponsor or person
Institute
Osaka University Graduate School of Dentistry
Institute
Department
Personal name
Funding Source
Organization
Kuraray Noritake Dental Inc.
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
Osaka Univ.
Address
1-8 Yamadaoka, Suita, Osaka
Tel
06-6879-2831
si-soumu-syomu@office.osaka-u.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
大阪大学歯学部附属病院（大阪府）,岡山大学附属病院（岡山県），東京歯科大学大学附属病院（東京都），東北大学附属病院，徳島大学附属病院
Other administrative information
Date of disclosure of the study information
| 2015 | 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
No longer recruiting
Date of protocol fixation
| 2015 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2015 | Year | 09 | Month | 01 | Day |
Anticipated trial start date
| 2015 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
| 2018 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2018 | Year | 12 | Month | 15 | Day |
Date analysis concluded
| 2019 | Year | 03 | Month | 31 | Day |
Other
Other related information
Clinical course of the crown and surround tissue
1) Objective investigation
(1) Evaluation of the crown
(2) Evaluation of opposing tooth
2) Subjective investigation (evaluation by patient)
Management information
Registered date
| 2015 | Year | 08 | Month | 12 | Day |
Last modified on
| 2019 | Year | 08 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021547
