UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055765 |
|---|---|
| Receipt number | R000063734 |
| Scientific Title | Clinical study on comparison of functions between FAT 3D printed dentures and conventional dentures |
| Date of disclosure of the study information | 2024/10/08 |
| Last modified on | 2025/10/13 11:35:30 |
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Basic information
Public title
Clinical study on the comparison of functions between 3D printed dentures with full-connected artificial teeth and conventional dentures
Acronym
Comparison of functions between 3D printed denture and conventional denture
Scientific Title
Clinical study on comparison of functions between FAT 3D printed dentures and conventional dentures
Scientific Title:Acronym
Comparison of functions between FAT 3D printed dentures and conventional dentures
Region
| Japan |
Condition
Condition
edentulous patient
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Functional evaluation of 3D printed dentures with full arch-connected prosthesis (FAT3D printed dentures) and conventional dentures will be performed over time to determine the potential clinical applications of 3D printed dentures.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Static occlusal contact conditions and functional conditions of complete dentures (1) masticatory capacity, (2) occlusal force, (3) occlusal contact,Other (nutritional status assessment, MNA)
Key secondary outcomes
Post-operative questionnaire evaluation of 3D printed dentures and regular dentures for dentists, technicians and subjects
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Intraoral application of FAT 3D printed complete dentures
Interventions/Control_2
Intraoral application of conventional heat-cured complete dentures
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
| 50 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Japanese, upper and lower edentulous subjects in the general dental clinic.
Patient must be in need of and willing to have his/her dentures remade (including hypodontics), be able to communicate, and agree to the purpose and significance of this study and the research plan.
Key exclusion criteria
Patients with abnormal jaw function, dysmotility mastication disorder, or history of dementia. Patients who cannot communicate in daily conversation.
Patients with motor-disorder mastication disorder,cerebrovascular disease, neurodegenerative disease, muscular disease, dementia, etc.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Katsushi |
| Middle name | |
| Last name | Tamaki |
Organization
Kanagawa Dental University
Division name
Specially Appointed Professors
Zip code
258
Address
Kanagawaken Yokosukashi Inokaacho 82
TEL
046-822-8880
tamaki@kdu.ac.jp
Public contact
Name of contact person
| 1st name | Katsushi |
| Middle name | |
| Last name | Tamaki |
Organization
Kanagawa Dental University
Division name
Specially Appointed Professors
Zip code
2380003
Address
Kanagawaken Yokosukashi Inokaacho 82
TEL
046-822-8880
Homepage URL
tamaki@kdu.ac.jp
Sponsor or person
Institute
Kanagawa Dental University
Institute
Department
Personal name
Katsushi Tamaki
Funding Source
Organization
SHOFU Corporation (Kyoto,Japan)
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Japan Prosthodontic Society
Address
Toukyoto minatoku siba 29-11 takaurabiru 4F
Tel
03-6722-6090
hotetsu-gakkai01@hotetsu.org
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
たまき歯科医院Tamaki Dental Office（神奈川県）、鎌倉大町歯科Kamakura Omachi Shika（神奈川県）、ナカエ歯科クリニックNakae Dental Clinic（神奈川県）、新城パーク歯科クリニックShinjyo Park Shika Clinic （神奈川県）、みどりの森デンタルクリニックMidorinomori Dental Clinic（神奈川県）、歯科技工所（株）フェリーチェFelice Dental Labo（神奈川県）、神奈川歯科大学歯学部社会歯科学系社会歯科学講座（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 10 | Month | 08 | 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
17
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
| 2023 | Year | 11 | Month | 16 | Day |
Date of IRB
| 2023 | Year | 11 | Month | 13 | Day |
Anticipated trial start date
| 2024 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
| 2025 | Year | 05 | Month | 31 | Day |
Date trial data considered complete
| 2025 | Year | 06 | Month | 30 | Day |
Date analysis concluded
| 2025 | Year | 08 | Month | 31 | Day |
Other
Other related information
As of April 7, 2025, 17 eligible patients (8 males and 9 females) have been completed and one additional eligible patient is in process. The project is scheduled to be completed at the end of this month. The results of the data from the 17 subjects will be presented at the 134th Annual Meeting of the Japanese Society of Prosthetic Dentistry to be held on May 17 and 18(Nagasaki, Japan).
This clinical study concluded by August 31, 2025. The comparison between conventional dentures (Conv. group) and FAT 3D-printed dentures (3D. group) at 6 months post-treatment was analyzed with a final sample size of 7 subjects in the Conv. group and 7 subjects in the 3D. group. The results are currently under review for publication in the Journal of the Japanese Society of Digital Dentistry (English Edition) (Manuscript Receipt Confirmation, No. 2). It is currently under peer review.
Management information
Registered date
| 2024 | Year | 10 | Month | 07 | Day |
Last modified on
| 2025 | 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=R000063734
