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

Email

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


Email

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

Email

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name