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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000043301
Receipt No. R000049437
Scientific Title Effects of non-face-to-face dental health education kits in the workplace: an intervention study
Date of disclosure of the study information 2021/02/12
Last modified on 2021/02/10

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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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