UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000037748
Receipt number R000041748
Scientific Title Development of Augmented Reality-based Practical Training Support Approach for Dental Education using Smartphone
Date of disclosure of the study information 2019/10/01
Last modified on 2019/08/20 18:27:34

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Basic information

Public title

Development of Augmented Reality-based Practical Training Support Approach for Dental Education using Smartphone

Acronym

AR-based Practical Training using Smartphone

Scientific Title

Development of Augmented Reality-based Practical Training Support Approach for Dental Education using Smartphone

Scientific Title:Acronym

AR-based Practical Training using Smartphone

Region

Japan


Condition

Condition

Not applicable

Classification by specialty

Dental medicine Not applicable Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The aim of this study is evaluate the effectiveness of "Augmented Reality (AR)-based practical training support application" for a smartphone, which enables three-dimensional visual confirmation of differences between deliverables and targets in real space by superimposing and displaying study targets.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Others

Developmental phase

Not applicable


Assessment

Primary outcomes

Results of spatial perceptual ability tests based on the mental cutting test (MCT) of molar shape recognition immediately after usage of AR-based practical training support application will be compared with those without AR-based appplication.

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

YES

Concealment

No need to know


Intervention

No. of arms

2

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Device,equipment

Interventions/Control_1

The intevention group will study the 3-dimensional morphology of human molars using AR-based practical training support application installed in a smartphone for 30 minutes.

Interventions/Control_2

The control group will study the morphology of human molars using 2-dimensional images from buccal, lingual, medial, distal, and occural views for 30 minutes.

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

18 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Students who must study the morphology of human teeth and can operate a smartphone.

Key exclusion criteria

Students who do not accept to be volanteer or can not operate a smartphone.

Target sample size

70


Research contact person

Name of lead principal investigator

1st name Mika
Middle name
Last name Kogure

Organization

Meilin Jounior College of Dentistry

Division name

School for Dental Hygienist

Zip code

950-2086

Address

Masago 3, Nishi-ku, Niigata-City, Niigata

TEL

025-232-6351

Email

kogure2009@me.com


Public contact

Name of contact person

1st name Mika
Middle name
Last name Kogure

Organization

Meilin Jounior College of Dentistry

Division name

School for Dental Hygienist

Zip code

950-2086

Address

Masago 3, Nishi-ku, Niigata-City, Niigata

TEL

025-232-6351

Homepage URL


Email

kogure2009@me.com


Sponsor or person

Institute

Meilin Jounior College of Dentistry

Institute

Department

Personal name



Funding Source

Organization

Ministry of Education, Culture, Sport, Science and Technology Japan

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Ethetic committee of Faculty of Dentistry, Tokyo Medical and Dental University

Address

Yushima 1-5-45, Bunky-ku, Tokyo

Tel

+81358035404

Email

d-hyoka.adm@tmd.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

明倫短期大学(新潟県),東京医科歯科大学(東京)


Other administrative information

Date of disclosure of the study information

2019 Year 10 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

Preinitiation

Date of protocol fixation

2019 Year 05 Month 16 Day

Date of IRB


Anticipated trial start date

2019 Year 06 Month 01 Day

Last follow-up date

2020 Year 12 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2019 Year 08 Month 20 Day

Last modified on

2019 Year 08 Month 20 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041748


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name