UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Clinical assessment of CAD/CAM produced crown with hybrid resin (Sera Smart) for molar teeth.
Title of the study (Brief title)	Clinical assessment of CAD/CAM produced crown with hybrid resin (Sera Smart) for molar teeth.
Region	Japan

Condition
Condition	Caries of molar tooth
Classification by specialty	Dental medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is estimate the clinical validity of CAD/CAM produced hybrid resin crown for molar teeth by follow up.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	crack/fracture of crown, dislocated, 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	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 clearance, antagonistic teeth are existed
Key exclusion criteria	abutment tooth is infected by periodontal disease/apical periodontitis, clasped tooth, bruxism
Target sample size	10

Research contact person
Name of lead principal investigator	Hitoshi Abekura
Organization	Hiroshima University Hospital
Division name	Department of Prosthetic Dentistry
Address	2-3,Kasumi 1-chome, Minami-Ku Hiroshima, Japan
TEL	082-257-5682
Email	abekura@hiroshima-u.ac.jp

Public contact
Name of contact person	Hironori Tsuka
Organization	Hiroshima University Hospital
Division name	Department of Prosthetic Dentistry
Address	2-3,Kasumi 1-chome, Minami-Ku Hiroshima, Japan
TEL	082-257-5682
Homepage URL
Email	tsuka311@hiroshima-u.ac.jp

Sponsor
Institute	Hiroshima University Hospital
Institute
Department

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

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2015 Year 08 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 01 Month 20 Day
Anticipated trial start date	2015 Year 08 Month 01 Day
Last follow-up date	2016 Year 06 Month 06 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2018 Year 03 Month 09 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 07 Month 28 Day
Last modified on	2018 Year 03 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021327