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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000028047
Receipt No. R000032092
Scientific Title Clinical evaluation of CAD / CAM digital denture
Date of disclosure of the study information 2017/08/01
Last modified on 2017/07/03

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Basic information
Public title Clinical evaluation of CAD / CAM digital denture
Acronym Clinical evaluation of CAD / CAM digital denture
Scientific Title Clinical evaluation of CAD / CAM digital denture
Scientific Title:Acronym Clinical evaluation of CAD / CAM digital denture
Region
Japan

Condition
Condition Patients who have totally edentulous upper and lower jaw
Classification by specialty
Dental medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To compare and examine of the clinical efficacy between the digital denture made by the CAD / CAM method and the denture manufactured by the conventional method.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Patient satisfaction
Key secondary outcomes Mastication function
occlusal force
Morphological evaluation.

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Digital denture made by CAD / CAM method
Interventions/Control_2 Denture made by conventional method
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 Patients who have totally edentulous upper and lower jaw and hope to make complete denture.
All patients received thorough explanations and had to complete a written informed consent form prior to being enrolled in the trial.
Key exclusion criteria Patients who are considered to have difficulties in dental treatment due to general health problems.
Patients who have difficulties in communicating on treatment due to reasons such as dementia.
Target sample size 20

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Isshiki Yukari
Organization Guraduate school of Dentistry
Kanagawa Dental University
Division name Department of Oral Interdisciplinary Medicine (OIM)
Zip code
Address Kanagawa Prifecture Yokosuka City Inaoka Town 82
TEL 0468228861
Email isshiki@kdu.ac.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Isshiki Yukari
Organization Guraduate school of Dentistry Kanagawa Dental University
Division name Department of Oral Interdisciplinary Medicine (OIM)
Zip code
Address Kanagawa Prifecture Yokosuka City Inaoka Town 82
TEL 0468228861
Homepage URL
Email isshiki@kdu.ac.jp

Sponsor
Institute Guraduate school of Dentistry
Kanagawa Dental University
Institute
Department

Funding Source
Organization Guraduate school of Dentistry
Kanagawa Dental University
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2017 Year 08 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 Open public recruiting
Date of protocol fixation
2017 Year 07 Month 01 Day
Date of IRB
Anticipated trial start date
2017 Year 07 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 07 Month 03 Day
Last modified on
2017 Year 07 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032092

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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