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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000021542
Receipt No. R000024839
Scientific Title The study about the effectiveness of applying oral scanner in impression technique to edentulous patient
Date of disclosure of the study information 2016/03/25
Last modified on 2016/04/04

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Basic information
Public title The study about the effectiveness of applying oral scanner in impression technique to edentulous patient
Acronym The study about the effectiveness of applying oral scanner in impression technique to edentulous patient
Scientific Title The study about the effectiveness of applying oral scanner in impression technique to edentulous patient
Scientific Title:Acronym 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

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

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
1st name
Middle name
Last name Shunsuke Minakuchi
Organization Tokyo Medical and Dental University
Division name Gerodontology and Oral Rehabilitation,
Zip code
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
1st name
Middle name
Last name Shunsuke Minakuchi
Organization Tokyo Medical and Dental University
Division name Gerodontology and Oral Rehabilitation,
Zip code
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

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)

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

Other administrative information
Date of disclosure of the study information
2016 Year 03 Month 25 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 09 Month 17 Day
Date of IRB
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

Other
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-open-bin/ctr_e/ctr_view.cgi?recptno=R000024839

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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