UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021542 |
|---|---|
| Receipt number | 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 10:52:04 |
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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
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
s.minakuchi.gerd@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024839
