UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The study about the effectiveness of applying oral scanner in impression technique to edentulous patient
Title of the study (Brief title)	The study about the effectiveness of applying oral scanner in impression technique to edentulous patient
Region	Japan

Condition
Condition	Edentulous jaw
Classification by specialty	Dental medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To verify the accuracy of digital impression
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	accuracy
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	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	Device,equipment
Interventions/Control_1	Digital impression(Used true definition scanner 3M.Cerec Omnicam Sirona)to Upper and lower jaw.Taking digital impression is one chair time.We required 1 hour to take impression. After taking digital impression Final impression using custom tray.Custom tray is made by 3D printer used impression date.
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

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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Edentulous jaw
Key exclusion criteria	Infectious
Target sample size	10

Research contact person
Name of lead principal investigator	Shunsuke Minakuchi
Organization	Tokyo Medical and Dental University
Division name	Gerodontology and Oral Rehabilitation,
Address	1-5-45, Yushima, Bunkyo, Tokyo 113-8549, JAPAN
TEL	03-3813-6111
Email	s.minakuchi.gerd@tmd.ac.jp

Public contact
Name of contact person	Shunsuke Minakuchi
Organization	Tokyo Medical and Dental University
Division name	Gerodontology and Oral Rehabilitation,
Address	1-5-45, Yushima, Bunkyo, Tokyo 113-8549, JAPAN
TEL	03-3813-6111
Homepage URL
Email	s.minakuchi.gerd@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	Sony Japan
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	2016 Year 03 Month 25 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2015 Year 09 Month 17 Day
Anticipated trial start date	2016 Year 04 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 03 Month 18 Day
Last modified on	2016 Year 04 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-bin/ctr_e/ctr_view.cgi?recptno=R000024839