UMIN-CTR Clinical Trial

Basic information
Public title	Effects of non-face-to-face dental health services in General Health Insurance Association
Acronym	Effects of non-face-to-face dental health services
Scientific Title	Effects of non-face-to-face dental health education kits in the workplace: an intervention study
Scientific Title:Acronym	Intervention effect of non-face-to-face dental health education kit
Region	Japan

Condition
Condition	Caries, periodontal disease
Classification by specialty	Dental medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This study was to examine the effect of non-face-to-face dental health education in order to contribute to the implementation of more efficient health services.
Basic objectives2	Others
Basic objectives -Others	For participants in department store health insurance insured, (1) to investigate the dental consultation status and results (presence or absence of dental caries and periodontal disease, etc.) and dental medical expenses. (2) to distribute dental goods health education teaching materials and clarify the effect of non-face-to-face dental health education one month later.
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	One month after sending the "dental education set" to the participant, the participant's dental health, dental consultation rate, dental literacy, smoking rate
Key secondary outcomes	The results of medical examination data and medical expenses

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification	YES
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	1
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Behavior,custom
Interventions/Control_1	Standard Adult Dental Examination Program and Non-face-to-face with dental education set
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	65 years-old >
Gender	Male and Female
Key inclusion criteria	Department store health insurance insured
Key exclusion criteria	Those who do not agree with the questionnaire survey
Target sample size	1000

Research contact person
Name of lead principal investigator	1st name Gen Middle name Last name Kobashi
Organization	Dokkyo Medical University
Division name	Department of Public Health
Zip code	321-0293
Address	880 Kitakobayashi, Mibu, Tochigi
TEL	0282-87-2133
Email	genkoba@dokkyomed.ac.jp

Public contact
Name of contact person	1st name Yasuo Middle name Last name Haruyama
Organization	Dokkyo Medical University
Division name	Center for Research Collaboration and Support
Zip code	321-0293
Address	880 Kitakobayashi, Mibu, Tochigi
TEL	0282-87-2113
Homepage URL
Email	yasuo-h@dokkyomed.ac.jp

Sponsor
Institute	Dokkyo Medical University
Institute
Department

Funding Source
Organization	Department store health insurance association
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	Dokkyo Medical University Bioethics Committee
Address	880 Kitakobayashi, Mibu, Tochigi
Tel	0282-87-2474
Email	kenkyu@dokkyomed.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 02 Month 12 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	2020 Year 12 Month 24 Day
Date of IRB	2021 Year 02 Month 06 Day
Anticipated trial start date	2021 Year 03 Month 01 Day
Last follow-up date	2021 Year 04 Month 30 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 02 Month 10 Day
Last modified on	2021 Year 02 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049437

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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