UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060839 |
|---|---|
| Receipt number | R000069614 |
| Scientific Title | Clinical Evaluation of Complete Dentures Fabricated Using a Novel Full-Color 3D Printer |
| Date of disclosure of the study information | 2026/03/05 |
| Last modified on | 2026/03/05 19:09:16 |
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Basic information
Public title
Clinical Evaluation of Complete Dentures Fabricated Using a Novel Full-Color 3D Printer
Acronym
Clinical Evaluation of Complete Dentures Fabricated Using a Novel Full-Color 3D Printe
Scientific Title
Clinical Evaluation of Complete Dentures Fabricated Using a Novel Full-Color 3D Printer
Scientific Title:Acronym
Clinical Evaluation of Complete Dentures Fabricated Using a Novel Full-Color 3D Printer
Region
| Japan |
Condition
Condition
Edentulous upper jaw
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to evaluate the fit and stability of complete dentures fabricated using a novel full-color 3D printer in comparison with those fabricated using conventional methods.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Denture retention
Visual Analog Scale (VAS)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
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
The retention force will be measured by placing two types of dentures intraorally.
Interventions/Control_2
Two types of dentures will be clinically fitted intraorally, and subjective evaluations will be conducted using a visual analog scale (VAS).
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 scheduled to receive a maxillary complete denture
Key exclusion criteria
Participants with problems caused by ill-fitting dentures
Participants with mental or cognitive impairments
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Mariko |
| Middle name | |
| Last name | Ohira |
Organization
Tokyo Dental College
Division name
Department of Removable Partial Prosthodontics
Zip code
1010061
Address
2-9-18 Kandamisaki-cho, Chiyoda-ku, Tokyo
TEL
03-6380-9167
mohira@tdc.ac.jp
Public contact
Name of contact person
| 1st name | Mariko |
| Middle name | |
| Last name | Ohira |
Organization
Tokyo Dental College
Division name
2-9-18 Kandamisaki-cho, Chiyoda-ku, Tokyo
Zip code
1010061
Address
2-9-18 Kandamisaki-cho, Chiyoda-ku, Tokyo
TEL
03-6380-9167
Homepage URL
mohira@tdc.ac.jp
Sponsor or person
Institute
Tokyo Dental College
Institute
Department
Personal name
Funding Source
Organization
Tokyo Dental College
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
Tokyo Dental College
Address
2-9-18 Kandamisaki-cho, Chiyoda-ku, Tokyo
Tel
03-6380-9114
drinri@tdc.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
| 2026 | Year | 03 | Month | 05 | 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
Open public recruiting
Date of protocol fixation
| 2025 | Year | 11 | Month | 14 | Day |
Date of IRB
| 2025 | Year | 12 | Month | 01 | Day |
Anticipated trial start date
| 2025 | Year | 12 | Month | 03 | Day |
Last follow-up date
| 2027 | Year | 03 | 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
| 2026 | Year | 03 | Month | 05 | Day |
Last modified on
| 2026 | Year | 03 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069614
