UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007046 |
|---|---|
| Receipt number | R000008289 |
| Scientific Title | Development of the method to fill patient data for prosthesis using dental liminescence material |
| Date of disclosure of the study information | 2012/02/01 |
| Last modified on | 2012/01/10 18:06:14 |
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Basic information
Public title
Development of the method to fill patient data for prosthesis using dental liminescence material
Acronym
Development of the method to fill patient data for prosthesis using dental liminescence material
Scientific Title
Development of the method to fill patient data for prosthesis using dental liminescence material
Scientific Title:Acronym
Development of the method to fill patient data for prosthesis using dental liminescence material
Region
| Japan |
Condition
Condition
Healthy adult dentulous men/wemen; 5 cases, treated patients; 15 cases
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is the development of writing information for dental prosthetic devices using luminescence materials.The denture or crown, marked with the name and bar code print a dental material containing a luminescence material, and equipment to investigate the impact of state and identity over time.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
We evaluate the surface roughness and the change in color after 3, 6, 12, 24 months.
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
This luminescence material set into prothesis when fitted it. After 3 months, 6 months, 12 months to 24 months to measure.
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
Healthy adult dentulous men/wemen or patients who receive routine health checkups.
Key exclusion criteria
Patients who cannot display their will by themselves, who cannot communicate and who always holds biomedical devices such as pacemakers
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tetsuo Ichikawa |
Organization
Institute of Health Biosciences, The University of Tokushima
Division name
Department of Oral and Maxillofacial Prosthodontics and Oral Implantology
Zip code
Address
3-18-15 Kuramoto-cho, Tokushima
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Institute of Health Biosciences, The University of Tokushima
Division name
Department of Oral and Maxillofacial Prosthodontics and Oral Implantology
Zip code
Address
TEL
0886337347
Homepage URL
Sponsor or person
Institute
Institute of Health Biosciences, The University of Tokushima, Department of Oral and Maxillofacial Prosthodontics and Oral Implantology
Institute
Department
Personal name
Funding Source
Organization
Institute of Health Biosciences, The University of Tokushima, 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
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
| 2012 | Year | 02 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2012 | Year | 02 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 02 | 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
| 2012 | Year | 01 | Month | 10 | Day |
Last modified on
| 2012 | Year | 01 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008289
