UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060641 |
|---|---|
| Receipt number | R000069355 |
| Scientific Title | A Study on the Development of a Denture Morphology Extension Repair Method Using Duplicate Dentures Fabricated with an Intraoral Scanner and a 3D Printer |
| Date of disclosure of the study information | 2026/02/11 |
| Last modified on | 2026/02/10 12:31:57 |
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Basic information
Public title
Development of a Denture Extension Repair Method Using Duplicate Dentures Fabricated with an Intraoral Scanner and a 3D Printer
Acronym
3D Denture Repair Study
Scientific Title
A Study on the Development of a Denture Morphology Extension Repair Method Using Duplicate Dentures Fabricated with an Intraoral Scanner and a 3D Printer
Scientific Title:Acronym
DENTURE-3D
Region
| Japan |
Condition
Condition
Denture wearers requiring denture base morphology modification
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate whether a denture morphology extension repair method using duplicate dentures fabricated from scan data of the existing dentures is clinically acceptable in terms of masticatory function and patient satisfaction when compared with the fabrication of new dentures.
In patients residing in nursing care facilities or those who are unable to visit dental clinics independently, performing repairs directly on the dentures currently in use may result in pain or discomfort. Because such patients often have difficulty seeking prompt dental care, this can lead to problems or misunderstandings between patients, their families or caregivers, and dentists. To avoid these issues, a repair approach using duplicate dentures has been proposed. However, conventional fabrication of duplicate dentures requires a large amount of alginate impression material and is associated with considerable dimensional changes of the impression material, making it difficult to perform in nursing care facilities or home-visit dental settings.
Although the application of digital technologies in domiciliary dental care has attracted increasing attention, there are still limited reports in this field. Prosthodontic treatment using duplicate dentures allows the functional morphology obtained with the existing dentures to be preserved and transferred to new dentures, thereby minimizing the amount of post-insertion adjustment and potentially shortening the adaptation period.
Basic objectives2
Others
Basic objectives -Others
To investigate the feasibility and clinical applicability of duplicate denture fabrication using an intraoral scanner and a 3D printer.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1.Evaluation of Denture Morphology Requiring Repair
Classification of edentulous patterns
(Miyachi classification)
Survey of denture examination and inspection records
(According to the Japan Prosthodontic Society guidelines)
Questionnaire survey
Questionnaire on subjective evaluation of dentures and frequency of use
Questionnaire on foods that can be chewed
Oral Health Impact Profile-14 (OHIP-14)
Open-ended responses (including duration of denture use)
Measurement of masticatory performance
Measurement of glucose extraction from gummy jelly
2.Subjective and Objective Evaluation of Masticatory Function
Comparison between repaired existing dentures and newly fabricated dentures
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
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
In this study, the intervention consists of scanning the existing dentures using an intraoral scanner, fabricating duplicate dentures with a 3D printer based on the scan data, and performing denture morphology extension repair using the duplicate dentures. In addition, new dentures will be fabricated, and masticatory function and patient satisfaction will be evaluated at each stage of denture use. All procedures will be performed within the scope of routine dental practice.
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who are able to attend the Department of Prosthodontics at Meikai University Hospital, receive routine dental care, and are using dentures determined to require denture base morphology modification.
Key exclusion criteria
Individuals with severe cognitive impairment, such as advanced dementia, who have difficulty understanding the study procedures or providing informed consent
Individuals with serious systemic diseases for whom continuation of dental treatment is considered difficult
Individuals who decline to participate in the study
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Fumiko |
| Middle name | |
| Last name | Narumi |
Organization
Meikai University,School of Dentistry
Division name
Department of Removable Prosthodontics, Division of Functional Preservation and Restoration,
Zip code
350-0283
Address
1-1 Keyakidai Sakado Saitama
TEL
0492792747
fumiko-o@dent.meikai.ac.jp
Public contact
Name of contact person
| 1st name | Fumiko |
| Middle name | |
| Last name | Narumi |
Organization
Meikai University,School of Dentistry
Division name
Meikai University,School of Dentistry
Zip code
350-0283
Address
1-1 Keyakidai Sakado Saitama
TEL
0492792747
Homepage URL
fumiko-o@dent.meikai.ac.jp
Sponsor or person
Institute
Meikai University
Institute
Department
Personal name
Funding Source
Organization
Meikai 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
Meikai University
Address
Meikai University
Tel
0492792747
fumiko-o@dent.meikai.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 | 02 | Month | 11 | 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 | 28 | Day |
Date of IRB
| 2026 | Year | 12 | Month | 01 | Day |
Anticipated trial start date
| 2026 | Year | 02 | Month | 12 | Day |
Last follow-up date
| 2030 | Year | 09 | Month | 30 | 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 | 02 | Month | 10 | Day |
Last modified on
| 2026 | Year | 02 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069355
