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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000018647
Receipt No. 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

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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
Email 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
Email amine@md.okayama-u.ac.jp

Sponsor
Institute Osaka University Graduate School of Dentistry
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021547

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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