UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043301 |
|---|---|
| Receipt number | 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 | 2023/08/15 17:35:45 |
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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
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
yasuo-h@dokkyomed.ac.jp
Sponsor or person
Institute
Dokkyo Medical University
Institute
Department
Personal name
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
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
854
Results
A total of 1435 participants were conducted, and 854 participants who answer questionnaires were collected. The plan is to analyze during 2023.
Results date posted
| 2023 | Year | 08 | Month | 15 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
The intervention has been completed, but the analysis has been delayed due to COVID-19.
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
No longer recruiting
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
| 2021 | Year | 07 | Month | 30 | Day |
Date trial data considered complete
| 2021 | Year | 08 | Month | 31 | Day |
Date analysis concluded
| 2021 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2021 | Year | 02 | Month | 10 | Day |
Last modified on
| 2023 | Year | 08 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049437
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
