UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000018820
Receipt number R000021771
Scientific Title Development and evaluation of the method to make the dental appliance using digital technology
Date of disclosure of the study information 2015/08/27
Last modified on 2019/03/27 20:08:24

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Basic information

Public title

Development and evaluation of the method to make the dental appliance using digital technology

Acronym

Development and evaluation of digital dental laboratory technology

Scientific Title

Development and evaluation of the method to make the dental appliance using digital technology

Scientific Title:Acronym

Development and evaluation of digital dental laboratory technology

Region

Japan


Condition

Condition

Missing teeth

Classification by specialty

Dental medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

We have developed a new digital system in which duplicate complete denture and dental retainer/connector are made using a digital dental laboratory system. The present research is to evaluate prosthodontics appliance in a clinical situation.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Dentist-reported outcome
Dentists have to answer the original questionare that evaluates the difference of the operability between the conventional dental appliance and this new method before and after operation.

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Device,equipment Maneuver

Interventions/Control_1

Taking the impression and the bite registration using the CAD/CAM duplicate denture for an hour
Manufacturing the retainer of the denture and the implant related prosthesis milled from PEEK disk
Delivering a temporary removable denture with CAD/CAM retainers/connectors for several months

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

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

-Denture wearers

Key exclusion criteria

-Communication difficulty

Target sample size

25


Research contact person

Name of lead principal investigator

1st name Tetsuo
Middle name
Last name Ichikawa

Organization

Institute of Biomedical Sciences, Tokushima University Graduate School

Division name

Department of Oral and Maxillofacial Prosthodontics and Oral Implantology

Zip code

770-8504

Address

3-18-15 Kuramoto-cho, Tokushima, Japan

TEL

088-633-7347

Email

c301551014@tokushima-u.ac.jp


Public contact

Name of contact person

1st name Kosuke
Middle name
Last name Kurahashi

Organization

Tokushima University Graduate School

Division name

Department of Oral and Maxillofacial Prosthodontics and Oral Implantology

Zip code

770-8504

Address

3-18-15 Kuramoto-cho, Tokushima, Japan

TEL

088-633-7347

Homepage URL


Email

c301551014@tokushima-u.ac.jp


Sponsor or person

Institute

Institute of Biomedical Sciences, Tokushima University Graduate School
Department of Oral and Maxillofacial Prosthodontics and Oral Implantology

Institute

Department

Personal name



Funding Source

Organization

Institute of Biomedical Sciences, Tokushima University Graduate School
Department of Oral and Maxillofacial Prosthodontics and Oral Implantology

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

University Hospital of Tokushima Clinical Trial Center for Developmental Therapeutics

Address

2-50-1 Kuramoto-cho, Tokushima, Japan

Tel

088-633-9294

Email

awachiken@tokushima-u.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

2015 Year 08 Month 27 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications


Number of participants that the trial has enrolled

8

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

Terminated

Date of protocol fixation

2015 Year 08 Month 24 Day

Date of IRB

2015 Year 09 Month 28 Day

Anticipated trial start date

2015 Year 10 Month 01 Day

Last follow-up date

2019 Year 02 Month 07 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2015 Year 08 Month 26 Day

Last modified on

2019 Year 03 Month 27 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021771


Research Plan
Registered date File name
2019/03/27 研究実施計画書.pdf

Research case data specifications
Registered date File name

Research case data
Registered date File name
2019/03/27 dentistry-07-00004.pdf