UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032558 |
|---|---|
| Receipt number | R000037109 |
| Scientific Title | Study on the usefulness of denture manufacturing method applying optical impression system and CAD / CAM technology |
| Date of disclosure of the study information | 2018/06/05 |
| Last modified on | 2019/11/11 11:47:42 |
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Basic information
Public title
Study on the usefulness of denture manufacturing method applying optical impression system and CAD / CAM technology
Acronym
On the usefulness of denture manufacturing method applying CAD / CAM technology
Scientific Title
Study on the usefulness of denture manufacturing method applying optical impression system and CAD / CAM technology
Scientific Title:Acronym
On the usefulness of denture manufacturing method applying CAD / CAM technology
Region
| Japan |
Condition
Condition
edentulous patient who received implant treatment
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim is to establish a method of replacing the patient's mouth environment with a model with a 3D printer and creating a method for preparing a denture for a patient who has been treated with oral implants with full mandibular prosthesis.
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Chewing function, patient satisfaction
Key secondary outcomes
Oral implant site, oral implant circumferential periodontal condition
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
| Device,equipment |
Interventions/Control_1
The superstructure is produced by digital method and compared with the old superstructure which is produced by the conventional method.
Period: one month wearing of denture
Frequency: denture adjustment every week.
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
| 50 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
edentulous patient who received implant treatment
Key exclusion criteria
Patients judged that researchers are not appropriate as research subjects
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Yusuke |
| Middle name | |
| Last name | Taniguchi |
Organization
Fukuoka Dental College
Division name
Departments of Oral Rehabilitation
Zip code
814-0104
Address
2-15-1 Tamura, Sawara-ku, Fukuoka 814-0193, Japan
TEL
092-801-0411
yuusuke@college.fdcnet.ac.jp
Public contact
Name of contact person
| 1st name | Yusuke |
| Middle name | |
| Last name | Taniguchi |
Organization
Fukuoka Dental College
Division name
Departments of Oral Rehabilitation
Zip code
814-0104
Address
2-15-1 Tamura, Sawara-ku, Fukuoka 814-0193, Japan
TEL
092-801-0411
Homepage URL
yuusuke@college.fdcnet.ac.jp
Sponsor or person
Institute
Fukuoka Dental College
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Fukuoka Dental College
Address
2-15-1 Tamura, Sawara-ku, Fukuoka 814-0193, Japan
Tel
092-801-0411
yuusuke@college.fdcnet.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
| 2018 | Year | 06 | Month | 05 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
6
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
| 2018 | Year | 05 | Month | 07 | Day |
Date of IRB
| 2018 | Year | 04 | Month | 09 | Day |
Anticipated trial start date
| 2018 | Year | 06 | Month | 05 | Day |
Last follow-up date
| 2019 | Year | 03 | 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
| 2018 | Year | 05 | Month | 11 | Day |
Last modified on
| 2019 | Year | 11 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037109
