UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042387 |
|---|---|
| Receipt number | R000048386 |
| Scientific Title | Morphological evaluation of denture base in removable partial denture fabricated from digital impression |
| Date of disclosure of the study information | 2020/12/01 |
| Last modified on | 2026/03/25 14:21:13 |
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Basic information
Public title
Morphological evaluation of denture base in removable partial denture fabricated from digital impression
Acronym
Morphological evaluation of denture base fabricated from digital impression
Scientific Title
Morphological evaluation of denture base in removable partial denture fabricated from digital impression
Scientific Title:Acronym
Morphological evaluation of denture base fabricated from digital impression
Region
| Japan |
Condition
Condition
partially edentulous dentition
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Comparison of 3D morphology of denture base fabricated from digital impression with that from conventional impression
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Morphological difference between denture base fabricated from digital impression and that from conventional impression
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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 who visit a denture outpatient clinic
Japanese over 20
Need for recovery of missing teeth with RPD
Key exclusion criteria
Acute symptoms of oral and craniofacial diseases
Mucosal lesions are observed
Excessive vomiting reflex
Patients with residual teeth with high tooth mobility
Contraction of infectious disease or systemic disease (leukemia, HIV, etc.)
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Junichiro |
| Middle name | |
| Last name | Wada |
Organization
Tokyo Medical and Dental University (TMDU)
Division name
Department of Removable Partial Prosthodontics, Graduate School of Medical and Dental Sciences
Zip code
113-8510
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo
TEL
03-5803-5515
wadajun.rpro@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Junichiro |
| Middle name | |
| Last name | Wada |
Organization
Tokyo Medical and Dental University (TMDU)
Division name
Department of Removable Partial Prosthodontics, Graduate School of Medical and Dental Sciences
Zip code
113-8510
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo
TEL
03-5803-5515
Homepage URL
wadajun.rpro@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University (TMDU)
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science, and Technology of Japan
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Medical and Dental University (TMDU)
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo
Tel
03-5803-5515
wadajun.rpro@tmd.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
| 2020 | Year | 12 | Month | 01 | Day |
Related information
URL releasing protocol
https://www.mdpi.com/2077-0383/12/22/7103
Publication of results
Published
Result
URL related to results and publications
https://www.mdpi.com/2077-0383/12/22/7103
Number of participants that the trial has enrolled
22
Results
The vertical discrepancy of the digital impression relative to the reference data (the mucosal surface morphology of a well-functioning in-use denture) was significantly greater than that of the conventional impression, whereas no significant difference was observed in the horizontal discrepancy. Meanwhile, mucosal thickness showed no significant correlation with the recorded residual ridge morphology, regardless of the impression technique.
Results date posted
| 2026 | Year | 03 | Month | 25 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2023 | Year | 11 | Month | 15 | Day |
Baseline Characteristics
Total of 22 participants (15 female, 7 male; mean age 78.2 (9.7) years) with partially edentulous dentition (Kennedy classification I or II).
Missing teeth number of target mucosal area: 2: 18.2%; 3: 36.4%; 4: 45.4%.
Mean mucosal thickness: 1.87 (0.30) mm
Participant flow
1. Dentures were not worn for 24 hours prior to data acquisition.
2. Optical impressions of the remaining dentition and the edentulous mucosa were obtained.
3. Selective pressure impressions of the remaining dentition and the edentulous mucosa were taken.
4. The well-functioning denture was scanned chairside using an intraoral scanner.
5. Mucosal thickness was measured using an ultrasonic diagnostic device.
Adverse events
None
Outcome measures
Vertical discrepancy relative to the reference data (the mucosal surface morphology of a well-functioning denture)
Horizontal discrepancy relative to the reference data (the mucosal surface morphology of a well-functioning denture)
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 02 | Month | 16 | Day |
Anticipated trial start date
| 2021 | Year | 02 | Month | 16 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Comparison of 3D morphology of denture base fabricated from digital impression with that from conventional impression
Management information
Registered date
| 2020 | Year | 11 | Month | 09 | Day |
Last modified on
| 2026 | Year | 03 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048386
