UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018460 |
|---|---|
| Receipt number | R000021323 |
| Scientific Title | Verification of the accuracy of fixed prosthetic apliance were manufactured by using the Arcus Digma II |
| Date of disclosure of the study information | 2015/07/28 |
| Last modified on | 2019/01/29 18:54:02 |
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Basic information
Public title
Verification of the accuracy of fixed prosthetic apliance were manufactured by using the Arcus Digma II
Acronym
Verification of the accuracy of fixed prosthetic apliance were manufactured by using the Arcus Digma II
Scientific Title
Verification of the accuracy of fixed prosthetic apliance were manufactured by using the Arcus Digma II
Scientific Title:Acronym
Verification of the accuracy of fixed prosthetic apliance were manufactured by using the Arcus Digma II
Region
| Japan |
Condition
Condition
caries
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Verification of the accuracy of CAD/CAM fixed prosthetic apliance between using jaw movement measuring device or not.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The adjustment amount made in subjects' mouth to compare investigated using three-dimensional scanner.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Prosthodontic appliance using a semi-adjustment articulator equipment (CAD / CAM crown)
Interventions/Control_2
Prosthodontic appliance using Digma module (CAD / CAM crown)
Interventions/Control_3
Prosthodontic appliance using a mean value articulator (CAD / CAM crowns)
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
Patients of Tokushima University Hospital Dental clinic
They have personality normal occlusion
Key exclusion criteria
Temporomandibular dysfunction
Systemic illness
Predictable bad tooth
The dental caries over a number of teeth
Many teeth missing
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuo Okura |
Organization
Tokushima university (Graduate School)
Division name
Department of Stomatognathic Function and Occlusal Reconstruction
Zip code
Address
3-18-15, Kuramoto-cho, Tokushima, Tokushima
TEL
0886-33-7350
okura.kazuo@tokushima-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshitaka Suzuki |
Organization
Tokushima university (Graduate School)
Division name
Department of Stomatognathic Function and Occlusal Reconstruction
Zip code
Address
3-18-15, Kuramoto-cho, Tokushima, Tokushima
TEL
0886-33-7350
Homepage URL
yosuzuki@tokushima-u.ac.jp
Sponsor or person
Institute
Tokushima university (Graduate School)
Department of Stomatognathic Function and Occlusal Reconstruction
Institute
Department
Personal name
Funding Source
Organization
Tokushima university (Graduate School)
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
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
徳島大学病院（徳島県）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 07 | Month | 28 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
Main results already published
Date of protocol fixation
| 2014 | Year | 07 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2019 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2019 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 07 | Month | 28 | Day |
Last modified on
| 2019 | Year | 01 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021323
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
