UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028047 |
|---|---|
| Receipt number | R000032092 |
| Scientific Title | Clinical evaluation of CAD / CAM digital denture |
| Date of disclosure of the study information | 2017/08/01 |
| Last modified on | 2021/07/05 10:37:50 |
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Basic information
Public title
Clinical evaluation of CAD / CAM digital denture
Acronym
Clinical evaluation of CAD / CAM digital denture
Scientific Title
Clinical evaluation of CAD / CAM digital denture
Scientific Title:Acronym
Clinical evaluation of CAD / CAM digital denture
Region
| Japan |
Condition
Condition
Patients who have totally edentulous upper and lower jaw
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare and examine of the clinical efficacy between the digital denture made by the CAD / CAM method and the denture manufactured by the conventional method.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Patient satisfaction
Key secondary outcomes
Mastication function
occlusal force
Morphological evaluation.
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Digital denture made by CAD / CAM method
Interventions/Control_2
Denture made by conventional method
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
Patients who have totally edentulous upper and lower jaw and hope to make complete denture.
All patients received thorough explanations and had to complete a written informed consent form prior to being enrolled in the trial.
Key exclusion criteria
Patients who are considered to have difficulties in dental treatment due to general health problems.
Patients who have difficulties in communicating on treatment due to reasons such as dementia.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Yukari |
| Middle name | |
| Last name | Isshiki |
Organization
Guraduate school of Dentistry
Kanagawa Dental University
Division name
Department of Oral Interdisciplinary Medicine (OIM)
Zip code
238-8580
Address
Kanagawa Prifecture Yokosuka City Inaoka Town 82
TEL
0468228861
isshiki@kdu.ac.jp
Public contact
Name of contact person
| 1st name | Yukari |
| Middle name | |
| Last name | Isshiki |
Organization
Guraduate school of Dentistry Kanagawa Dental University
Division name
Department of Oral Interdisciplinary Medicine (OIM)
Zip code
238-8580
Address
Kanagawa Prifecture Yokosuka City Inaoka Town 82
TEL
0468228861
Homepage URL
isshiki@kdu.ac.jp
Sponsor or person
Institute
Guraduate school of Dentistry
Kanagawa Dental University
Institute
Department
Personal name
Funding Source
Organization
Guraduate school of Dentistry
Kanagawa Dental University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kanagawa Dental University Research Ethics Committee
Address
Kanagawa Prifecture Yokosuka City Inaoka Town 82
Tel
046822969
murakami@kdu.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
CRB3180004
Org. issuing International ID_1
National Institutes for Quantum and Radiological Science and Technology
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 08 | 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
Completed
Date of protocol fixation
| 2017 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 07 | Month | 22 | Day |
Anticipated trial start date
| 2017 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 07 | 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
| 2017 | Year | 07 | Month | 03 | Day |
Last modified on
| 2021 | Year | 07 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032092
