UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000028047
Receipt number R000032092
Scientific Title Clinical evaluation of CAD / CAM digital denture
Date of disclosure of the study information 2017/08/01
Last modified on 2021/07/05 10:37:50

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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

Name of lead principal investigator

1st name Yukari
Middle name
Last name Isshiki

Organization

Guraduate school of Dentistry
Kanagawa Dental University

Division name

Department of Oral Interdisciplinary Medicine (OIM)

Zip code

238-8580

Address

Kanagawa Prifecture Yokosuka City Inaoka Town 82

TEL

0468228861

Email

isshiki@kdu.ac.jp


Public contact

Name of contact person

1st name Yukari
Middle name
Last name Isshiki

Organization

Guraduate school of Dentistry Kanagawa Dental University

Division name

Department of Oral Interdisciplinary Medicine (OIM)

Zip code

238-8580

Address

Kanagawa Prifecture Yokosuka City Inaoka Town 82

TEL

0468228861

Homepage URL


Email

isshiki@kdu.ac.jp


Sponsor or person

Institute

Guraduate school of Dentistry
Kanagawa Dental University

Institute

Department

Personal name



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

Kanagawa Dental University Research Ethics Committee

Address

Kanagawa Prifecture Yokosuka City Inaoka Town 82

Tel

046822969

Email

murakami@kdu.ac.jp


Secondary IDs

Secondary IDs

YES

Study ID_1

CRB3180004

Org. issuing International ID_1

National Institutes for Quantum and Radiological Science and Technology

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

Completed

Date of protocol fixation

2017 Year 07 Month 01 Day

Date of IRB

2016 Year 07 Month 22 Day

Anticipated trial start date

2017 Year 07 Month 01 Day

Last follow-up date

2020 Year 07 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

2017 Year 07 Month 03 Day

Last modified on

2021 Year 07 Month 05 Day



Link to view the page

Value
https://center6.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