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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000007046
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Institute of Health Biosciences, The University of Tokushima, Department of Oral and Maxillofacial Prosthodontics and Oral Implantology
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008289

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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