UMIN-CTR Clinical Trial

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
Email	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
Email	shimpo-hidemasa@tsurumi-u.ac.jp

Sponsor
Institute	surumi University School of Dental Medicine Removable Prosthodontics
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043255