UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018820 |
|---|---|
| Receipt number | R000021771 |
| Scientific Title | Development and evaluation of the method to make the dental appliance using digital technology |
| Date of disclosure of the study information | 2015/08/27 |
| Last modified on | 2019/03/27 20:08:24 |
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Basic information
Public title
Development and evaluation of the method to make the dental appliance using digital technology
Acronym
Development and evaluation of digital dental laboratory technology
Scientific Title
Development and evaluation of the method to make the dental appliance using digital technology
Scientific Title:Acronym
Development and evaluation of digital dental laboratory technology
Region
| Japan |
Condition
Condition
Missing teeth
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We have developed a new digital system in which duplicate complete denture and dental retainer/connector are made using a digital dental laboratory system. The present research is to evaluate prosthodontics appliance in a clinical situation.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Dentist-reported outcome
Dentists have to answer the original questionare that evaluates the difference of the operability between the conventional dental appliance and this new method before and after operation.
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 | Maneuver |
Interventions/Control_1
Taking the impression and the bite registration using the CAD/CAM duplicate denture for an hour
Manufacturing the retainer of the denture and the implant related prosthesis milled from PEEK disk
Delivering a temporary removable denture with CAD/CAM retainers/connectors for several months
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
-Denture wearers
Key exclusion criteria
-Communication difficulty
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | Tetsuo |
| Middle name | |
| Last name | Ichikawa |
Organization
Institute of Biomedical Sciences, Tokushima University Graduate School
Division name
Department of Oral and Maxillofacial Prosthodontics and Oral Implantology
Zip code
770-8504
Address
3-18-15 Kuramoto-cho, Tokushima, Japan
TEL
088-633-7347
c301551014@tokushima-u.ac.jp
Public contact
Name of contact person
| 1st name | Kosuke |
| Middle name | |
| Last name | Kurahashi |
Organization
Tokushima University Graduate School
Division name
Department of Oral and Maxillofacial Prosthodontics and Oral Implantology
Zip code
770-8504
Address
3-18-15 Kuramoto-cho, Tokushima, Japan
TEL
088-633-7347
Homepage URL
c301551014@tokushima-u.ac.jp
Sponsor or person
Institute
Institute of Biomedical Sciences, Tokushima University Graduate School
Department of Oral and Maxillofacial Prosthodontics and Oral Implantology
Institute
Department
Personal name
Funding Source
Organization
Institute of Biomedical Sciences, Tokushima University Graduate School
Department of Oral and Maxillofacial Prosthodontics and Oral Implantology
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
University Hospital of Tokushima Clinical Trial Center for Developmental Therapeutics
Address
2-50-1 Kuramoto-cho, Tokushima, Japan
Tel
088-633-9294
awachiken@tokushima-u.ac.jp
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
| 2015 | Year | 08 | Month | 27 | 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
8
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
Terminated
Date of protocol fixation
| 2015 | Year | 08 | Month | 24 | Day |
Date of IRB
| 2015 | Year | 09 | Month | 28 | Day |
Anticipated trial start date
| 2015 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 02 | Month | 07 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 08 | Month | 26 | Day |
Last modified on
| 2019 | Year | 03 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021771
