UMIN-CTR Clinical Trial

Basic information
Public title	Development and evaluation of e-learning materials on dental hygiene education
Acronym	Development and evaluation of e-learning materials on dental hygiene education
Scientific Title	Development and evaluation of e-learning materials on dental hygiene education
Scientific Title:Acronym	Development and evaluation of e-learning materials on dental hygiene education
Region	Japan

Condition
Condition	healthy subjects
Classification by specialty	Not applicable
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To develop e-learning materials anyone can access, and evaluate these effects to clarify effective methods to utilize.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Scores of pre- and post-examinations.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Other
Interventions/Control_1	Participants in the test group will learn using e-learning materials.
Interventions/Control_2	Participants in the control group will learn using e-learning and printed-learning materials.
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Students who will learn with the e-learning and printed learning materials, and those who agree with this study.
Key exclusion criteria	Those who would not agree with the study.
Target sample size	1110

Research contact person
Name of lead principal investigator	1st name Akane Middle name Last name Takenouchi
Organization	Shinjuku Medical Career College
Division name	Dental Hygiene Course
Zip code	160-0017
Address	5 Samon-cho, Shinjuku-ku, Tokyo, Japan
TEL	03-3352-6811
Email	ssjs.takenouchi@gmail.com

Public contact
Name of contact person	1st name Akane Middle name Last name Takenouchi
Organization	Shinjuku Medical Career College
Division name	Dental Hygiene Course
Zip code	160-0017
Address	5 Samon-cho, Shinjuku-ku, Tokyo, Japan
TEL	03-3352-6811
Homepage URL
Email	ssjs.takenouchi@gmail.com

Sponsor
Institute	Shinjuku Medical Career College
Institute
Department

Funding Source
Organization	Shinjuku Medical Career College
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Shinjuku Medical Career College
Address	5 Samon-cho, Shinjuku-ku, Tokyo, Japan
Tel	03-3352-6811
Email	okamura@ssjs.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	2021 Year 09 Month 07 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	Open public recruiting
Date of protocol fixation	2021 Year 07 Month 08 Day
Date of IRB	2021 Year 07 Month 08 Day
Anticipated trial start date	2021 Year 09 Month 07 Day
Last follow-up date	2024 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	2021 Year 09 Month 07 Day
Last modified on	2021 Year 09 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051841