UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The development of the tooth preparation training system of using CAD/CAM sysutem
Title of the study (Brief title)	The development of the tooth preparation training system of using CAD/CAM sysutem
Region	Japan

Condition
Condition	tooth preparation
Classification by specialty	Dental medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The development of the tooth preparation effective training system of using the evaluation function of the CAD / CAM system
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase

Assessment
Primary outcomes	Comparison of artificial teeth and initially formed artificial tooth formed on the second
Key secondary outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	3
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Maneuver
Interventions/Control_1	using only the evaluation software, which is mounted in the CAD / CAM system
Interventions/Control_2	Performing feedback by the leaders in terms of using the evaluation software, which is mounted in the CAD / CAM system.
Interventions/Control_3	The control group
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	24 years-old <
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Tokyo Medical and Dental University Dental Hospital residents
Key exclusion criteria	nothing special
Target sample size	45

Research contact person
Name of lead principal investigator	Kouji Araki
Organization	Tokyo Medical and Dental University
Division name	Educational System in Dentistry
Address	Tokyo, Bunkyoward Yushima1-5-45
TEL	03-5803-4577
Email	k.araki.gend@tmd.ac.jp

Public contact
Name of contact person	Akitaka Hattori
Organization	Tokyo Medical and Dental University
Division name	Educational System in Dentistry
Address	Tokyo, Bunkyoward Yushima1-5-45
TEL	03-5803-4577
Homepage URL
Email	akitesd@tmd.ac.jp

Sponsor
Institute	Tokyo Medical and Dental University
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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	東京医科歯科大学歯学部（東京都）

Other administrative information
Date of disclosure of the study information	2016 Year 09 Month 01 Day

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

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

Management information
Registered date	2016 Year 07 Month 06 Day
Last modified on	2016 Year 07 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026446