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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000017067
Receipt No. R000019797
Scientific Title Clinical assessment of molar crown fabricated with CAD/CAM hybrid resin (Cerasmart)
Date of disclosure of the study information 2015/04/10
Last modified on 2016/10/07

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Basic information
Public title Clinical assessment of molar crown fabricated with CAD/CAM hybrid resin (Cerasmart)
Acronym Clinical assessment of molar crown fabricated with CAD/CAM hybrid resin
Scientific Title Clinical assessment of molar crown fabricated with CAD/CAM hybrid resin (Cerasmart)
Scientific Title:Acronym Clinical assessment of molar crown fabricated with CAD/CAM hybrid resin
Region
Japan

Condition
Condition Molar Caries
Classification by specialty
Dental medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Clinical assessment of molar crown fabricated with CAD/CAM hybrid resin
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
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 condition of metal allergy

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 cleaeance, antagonistic teeth are existed
Key exclusion criteria abutement tooth is infected by periodontal disease/apical periodontitis, clasped tooth, bruxism
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kiyoshi Koyano
Organization Kyushu University, Faculty of Dental Science
Division name Division of Oral Rehabilitation
Zip code
Address 3-1-1 Maidashi Higashi-ku, Fukuoka
TEL 092-642-6441
Email koyano@dent.kyushu-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoichiro Ogino
Organization Kyushu University, Faculty of Dental Science
Division name Division of Oral Rehabilitation
Zip code
Address 3-1-1 Maidashi Higashi-ku, Fukuoka
TEL 092-642-6441
Homepage URL
Email ogino@dent.kyushu-u.ac.jp

Sponsor
Institute Section of Implant and Rehabilitative Dentistry,Division of Oral Rehabilitation, Faculty of Dental Science, Kyushu University
Institute
Department

Funding Source
Organization GC Corporation
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization JAPAN

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 九州大学病院義歯補綴科(福岡県)

Other administrative information
Date of disclosure of the study information
2015 Year 04 Month 10 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
2015 Year 03 Month 23 Day
Date of IRB
Anticipated trial start date
2015 Year 04 Month 10 Day
Last follow-up date
2017 Year 06 Month 30 Day
Date of closure to data entry
2017 Year 07 Month 31 Day
Date trial data considered complete
2017 Year 07 Month 31 Day
Date analysis concluded
2017 Year 07 Month 31 Day

Other
Other related information

Management information
Registered date
2015 Year 04 Month 07 Day
Last modified on
2016 Year 10 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019797

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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