UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037947 |
|---|---|
| Receipt number | R000043255 |
| Scientific Title | Verification of clinical effect of 3D printing dentures by randomized controlled trial |
| Date of disclosure of the study information | 2020/01/01 |
| Last modified on | 2019/09/07 17:29:02 |
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Basic information
Public title
Verification of clinical effect of 3D printing dentures by randomized controlled trial
Acronym
Verification of clinical effect of 3D printing dentures
Scientific Title
Verification of clinical effect of 3D printing dentures by randomized controlled trial
Scientific Title:Acronym
Verification of clinical effect of 3D printing dentures by randomized controlled trial
Region
| Japan |
Condition
Condition
Edentulous jaw
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Dental computer-aided designs and computer-aided machining (CAD/CAM) technology has rapidly improved from the beginning of the 21st century with the remarkable development of digital technology . in the field of dental prosthesis, prosthetic devices are manufactured by CAD/CAM.Especially in the CAD / CAM crown, it has spread rapidly due to the inclusion of social insurance and the acquisition of optical impressions. On the other hand, CAD / CAM has also been attempted for complete dentures. Development of high-strength PMMA discs and resin for 3D printers is also progressing rapidly , and the spread of CAD / CAM complete dentures is expected.However, there are few reports of clinical application cases of complete dentures made using a 3D printer, and there are many unclear points.Therefore, in establishing clinical evidence, comprehensive evaluation will be performed based on subjective and objective evaluation of complete dentures manufactured using a 3D printer. It is considered very useful to accumulate and report evidence that contributes to the formulation of clinical guidelines for complete dentures made using 3D printers.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase III
Assessment
Primary outcomes
Oral Health-related QOL Scale OHIP-EDENT-J
Key secondary outcomes
Patient satisfaction (100mmVAS)
Direct and indirect expenses and time required for medical care
Three-dimensional data of denture shape
Chewing efficiency
Occlusal contact area
Success rate
Complications
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Cluster
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
The control group manufactures complete dentures according to the law.
Interventions/Control_2
In the intervention group, the occlusal plate obtained by occlusion and the mucosal surface of the work model are scanned with a model scanner. The denture is designed based on the STL data. After that, the denture is made with a 3D printer.
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
1) Adults with upper and lower edentulous jaws2) Those who have old dentures and who want to make complete dentures3) Those who can visit the hospital regularly and agree to the research4) Those who have received sufficient explanation for participation in this study, and who have received sufficient written consent from the patient himself / herself with sufficient understanding
Key exclusion criteria
1) Person with temporomandibular disorder2) Person with jaw defect3) Those who have problems with their general health and may have difficulty in dental treatment.4) Those who have difficulty in communicating for treatment due to dementia, etc.5) Those who have significant difficulty in going to hospital due to physical, mental or social reasons6) In addition, the person in charge of the research or the person judged by the researcher to be inappropriate for conducting this research safely
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Shimpo |
| Middle name | |
| Last name | Hidemasa |
Organization
Tsurumi University School of Dental Medicine
Division name
Removable Prosthodontics
Zip code
230-8501
Address
2-1-3,Tsurumi,Tsurumi-ku, Yokohama 230-8501
TEL
0455808414
okubo-c@tsurumi-u.ac.jp
Public contact
Name of contact person
| 1st name | Ohkubo |
| Middle name | |
| Last name | Chikahiro |
Organization
Tsurumi University School of Dental Medicine
Division name
Removable Prosthodontics
Zip code
230-8501
Address
2-1-3,Tsurumi,Tsurumi-ku, Yokohama 230-850
TEL
0455808414
Homepage URL
shimpo-hidemasa@tsurumi-u.ac.jp
Sponsor or person
Institute
surumi University School of Dental Medicine Removable Prosthodontics
Institute
Department
Personal name
Funding Source
Organization
Mitsui Chemicals, Inc.
Organization
Division
Category of Funding Organization
Profit organization
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
Address
1-5-45, Yushima, Bunnkyoku,Tokyo
Tel
0358034712
d-hyoka.adm@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 | 01 | Month | 01 | 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
| 2019 | Year | 08 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2020 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 12 | 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
| 2019 | Year | 09 | Month | 06 | Day |
Last modified on
| 2019 | Year | 09 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043255
