UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061365 |
|---|---|
| Receipt number | R000067262 |
| Scientific Title | Evaluation of the clinical effectiveness of digital dentures produced by 3D printers |
| Date of disclosure of the study information | 2026/04/23 |
| Last modified on | 2026/04/23 23:34:22 |
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Basic information
Public title
Evaluation of the clinical effectiveness of digital dentures produced by 3D printers
Acronym
Clinical effectiveness of 3D-printed dentures
Scientific Title
Evaluation of the clinical effectiveness of digital dentures produced by 3D printers
Scientific Title:Acronym
Clinical effectiveness of 3D-printed dentures
Region
| Japan |
Condition
Condition
Edentulous upper and lower jaws
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The clinical effectiveness of digitally manufactured dentures produced using a 3D printer will be compared and evaluated with that of dentures produced using conventional methods. (Satisfaction evaluation, masticatory function evaluation, occlusal force, contact area, time study, and cost evaluation)
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
satisfaction evaluation
Key secondary outcomes
masticatory function evaluation, occlusal force, contact area, time study, and cost evaluation
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
Patients with edentulous upper and lower jaws who visited Kanagawa Dental University Hospital requesting complete dentures
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
Patients with edentulous upper and lower jaws who visited Kanagawa Dental University Hospital requesting complete dentures
Key exclusion criteria
1. Patients with physical or mental issues
2. Patients who cannot understand or read Japanese
3. Patients with dementia or other conditions that make it difficult for them to cooperate with questionnaire evaluations
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Yukari |
| Middle name | |
| Last name | Tomino |
Organization
Kanagawa Dental University
Division name
Removable Prosthodontics
Zip code
2388570
Address
1-23 Ogawa-cho, Yokosuka- City, Kanagawa Prefecture
TEL
0468228883
isshiki@kdu.ac.jp
Public contact
Name of contact person
| 1st name | Yukari |
| Middle name | |
| Last name | Tomino |
Organization
Kanagawa Dental University
Division name
Removable Prosthodontics
Zip code
2388570
Address
1-23 Ogawa-cho, Yokosuka- City, Kanagawa Prefecture
TEL
0468228883
Homepage URL
isshiki@kdu.ac.jp
Sponsor or person
Institute
Kanagawa Dental University
Institute
Department
Personal name
Tomino Yukari
Funding Source
Organization
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
Address
1-23 Ogawa-cho, Yokosuka- City, Kanagawa Prefecture
Tel
0468228883
isshiki@kdu.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 | 04 | Month | 23 | 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
| 2025 | Year | 08 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 10 | Month | 01 | 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 | 04 | Month | 23 | Day |
Last modified on
| 2026 | Year | 04 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000067262
