UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019434 |
|---|---|
| Receipt number | R000022479 |
| Scientific Title | Clinical evaluation of newly developed complete CAD/CAM dentures in fully edentulous patients. |
| Date of disclosure of the study information | 2015/10/30 |
| Last modified on | 2016/12/26 10:45:10 |
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Basic information
Public title
Clinical evaluation of newly developed complete CAD/CAM dentures in fully edentulous patients.
Acronym
Clinical evaluation of newly developed complete CAD/CAM dentures.
Scientific Title
Clinical evaluation of newly developed complete CAD/CAM dentures in fully edentulous patients.
Scientific Title:Acronym
Clinical evaluation of newly developed complete CAD/CAM dentures.
Region
| Japan |
Condition
Condition
Missing teeth
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess safety, feasibility and efficacy of newly developed CAD/CAM dentures in fully edentulous patients.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Oral health related Quality of Life at 1 month after completion of the denture adjustment.
Key secondary outcomes
1) Fitting and stability of denture
2 )Onset of the allergic symptom
3 )Fracture of denture
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Complete CAD/CAM denture/Conventional complete denture (Subjects receive Conventional complete denture
and outcome evaluation at first. Subjects receive Complete CAD/CAM denture subsequently.)
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
1) Patients who use Conventional complete denture without complications.
2)Patient willing and able to provide informed consent.
Key exclusion criteria
1) Patients who are difficult to provide informed consent, for example dementia.
2) Allergy of acrylic resin
3) Patients who difficult to follow up.
4) Other patients who are judged by physician as being unsuitable
Target sample size
7
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takuo Kuboki |
Organization
Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences, Okayama, Japan
Division name
Department of Oral Rehabilitation and Regenerative Medicine
Zip code
Address
2-5-1, Shikata-cho,Kita-ku, Okayama, Japan
TEL
+81-86-235-6682
kuboki@md.okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Aya Ono |
Organization
Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences, Okayama, Jap
Division name
Department of Oral Rehabilitation and Regenerative Medicine
Zip code
Address
2-5-1, Shikata-cho,Kita-ku, Okayama, Japan
TEL
+81-86-235-6682
Homepage URL
a-kimura@md.okayama-u.ac.jp
Sponsor or person
Institute
Department of Oral Rehabilitation and Regenerative Medicine, Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences, Okayama, Japan
Institute
Department
Personal name
Funding Source
Organization
Mitsui Chemicals, Inc.
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
| 2015 | Year | 10 | Month | 30 | 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
No longer recruiting
Date of protocol fixation
| 2015 | Year | 09 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 11 | 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
| 2015 | Year | 10 | Month | 21 | Day |
Last modified on
| 2016 | Year | 12 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022479
| 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 |
