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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000037748
Receipt No. 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

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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
Institute Meilin Jounior College of Dentistry
Institute
Department

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
URL(English) https://upload.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


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