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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000032558
Receipt No. R000037109
Official scientific title of the study 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 2018/11/10

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Basic information
Official scientific title of the study Study on the usefulness of denture manufacturing method applying optical impression system and CAD / CAM technology
Title of the study (Brief title) 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 Yusuke Taniguchi
Organization Fukuoka Dental College
Division name Departments of Oral Rehabilitation
Address 2-15-1 Tamura, Sawara-ku, Fukuoka 814-0193, Japan
TEL 092-801-0411
Email yuusuke@college.fdcnet.ac.jp

Public contact
Name of contact person Yusuke Taniguchi
Organization Fukuoka Dental College
Division name Departments of Oral Rehabilitation
Address 2-15-1 Tamura, Sawara-ku, Fukuoka 814-0193, Japan
TEL 092-801-0411
Homepage URL
Email yuusuke@college.fdcnet.ac.jp

Sponsor
Institute Fukuoka Dental College
Institute
Department

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)

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

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2018 Year 05 Month 07 Day
Anticipated trial start date
2018 Year 06 Month 05 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2018 Year 05 Month 11 Day
Last modified on
2018 Year 11 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037109

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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