UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042098 |
|---|---|
| Receipt number | R000048044 |
| Scientific Title | A prospective clinical study of complete dentures fabricated CAD/CAM using milling custom disc. |
| Date of disclosure of the study information | 2020/10/30 |
| Last modified on | 2020/10/13 16:23:49 |
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Basic information
Public title
A prospective clinical study of complete dentures fabricated CAD/CAM using milling custom disc.
Acronym
A prospective clinical study of complete dentures fabricated CAD/CAM using milling custom disc.
Scientific Title
A prospective clinical study of complete dentures fabricated CAD/CAM using milling custom disc.
Scientific Title:Acronym
A prospective clinical study of complete dentures fabricated CAD/CAM using milling custom disc.
Region
| Japan |
Condition
Condition
missing teeth
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Comparison of manufacturing time and cost of complete dentures fabricated CAD/CAM using milling custom disc with conventional methods.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Patient satisfaction
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
| Maneuver |
Interventions/Control_1
single-group study
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
Those who wish to make upper and lower dentures in the Tokyo Medical and Dental University (the field of dentistry for the elderly) and who have received sufficient explanation to participate in this study among patients who do not fall under any of the exclusion criteria, and have obtained written consent of the patient himself/herself with sufficient understanding.
Key exclusion criteria
Those who have defects in the upper and lower jaw bones, those who have problems with their whole body health and who think dental treatment is difficult, those who have difficulty communicating with treatment due to dementia, etc., and those who experience significant difficulties in coming to the hospital for physical, mental, or social reasons.
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | Syunsuke |
| Middle name | |
| Last name | Minakuchi |
Organization
TOKYO MEDICAL and DENTAL UNIVERSITY
Division name
Gerodontology and Oral Rehabilitation
Zip code
1138519
Address
1-5-45,yushima,bunkyo-ku,tokyo
TEL
03-5803-5582
s.minakuchi.gerd@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Manabu |
| Middle name | |
| Last name | Kanazawa |
Organization
TOKYO MEDICAL and DENTAL UNIVERSITY
Division name
Gerodontology and Oral Rehabilitation
Zip code
1138519
Address
1-5-45,yushima,bunkyo-ku,tokyo
TEL
03-5803-4645
Homepage URL
m.kanazawa.gerd@tmd.ac.jp
Sponsor or person
Institute
TOKYO MEDICAL and DENTAL UNIVERSITY
Institute
Department
Personal name
Funding Source
Organization
Self-procurement
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
TOKYO MEDICAL and DENTAL UNIVERSITY
Address
1-5-45,yushima,bunkyo-ku,tokyo
Tel
0358035583
r.otake.gerd@tmd.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
| 2020 | 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
Preinitiation
Date of protocol fixation
| 2020 | Year | 10 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2021 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 10 | Month | 13 | Day |
Last modified on
| 2020 | Year | 10 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048044
| 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 |
