UMIN-CTR Clinical Trial

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