UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048466 |
|---|---|
| Receipt number | R000055203 |
| Scientific Title | Verification of the effects of regular dental health examinations and health guidance and effective methods for recommending consultations |
| Date of disclosure of the study information | 2022/07/31 |
| Last modified on | 2023/08/04 10:39:15 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Verification of the effects of regular dental health examinations and health guidance and effective methods for recommending consultations
Acronym
Verification of the effects of regular dental health examinations and health guidance and effective methods for recommending consultations
Scientific Title
Verification of the effects of regular dental health examinations and health guidance and effective methods for recommending consultations
Scientific Title:Acronym
Verification of the effectiveness of the dental consultation recommendation method
Region
| Japan |
Condition
Condition
Periodontal disease
Classification by specialty
| Dental medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
For employees and residents who do not regularly visit a dental institution, the effect of visiting a dental institution and changing oral health behavior by continuously encouraging consultation and recommending oral health behavior using ICT tools Verify.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Dental clinic consultation rate
Key secondary outcomes
Retention rate of oral health behavior
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Provide ICT tools, use at least once a month, and feed back simple measurement results
Interventions/Control_2
Providing simple dental-related status
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
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Those who belong to or reside in a research participating organization (company, local government) at the time of obtaining consent
Those who are 20 years old or older at the time of consent acquisition
Those who have obtained electronic or written consent at their own free will
Key exclusion criteria
Research participants voluntarily withdraw their consent
Target sample size
2000
Research contact person
Name of lead principal investigator
| 1st name | Akihiko |
| Middle name | |
| Last name | Gondo |
Organization
NTT DATA Corporation
Division name
Digital Welfare Division 2nd Section
Zip code
135-6033
Address
3-3-3 Toyosu, Koto-ku, Tokyo
TEL
03-5546-8202
dental-support@nttdata-strategy.com
Public contact
Name of contact person
| 1st name | dai |
| Middle name | |
| Last name | Tomonaga |
Organization
NTT DATA INSTITUTE OF MANAGEMENT CONSULTING,Inc.
Division name
Life Value Creation Ynit
Zip code
102-0093
Address
7-9, Hirakawacho 2-chome, Chiyoda-ku, Tokyo 102-0093, Japan
TEL
03-5213-4091
Homepage URL
dental-support@nttdata-strategy.com
Sponsor or person
Institute
Ministry of Health, Labour and Welfare
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
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
Medical Information System Development Center
Address
1-1, Kagurazaka, Shinjuku-ku, Tokyo
Tel
03-3267-1921
jimukyoku@medis.or.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
| 2022 | Year | 07 | Month | 31 | 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
2109
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
Completed
Date of protocol fixation
| 2022 | Year | 07 | Month | 31 | Day |
Date of IRB
| 2022 | Year | 06 | Month | 24 | Day |
Anticipated trial start date
| 2022 | Year | 08 | Month | 08 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2023 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2022 | Year | 07 | Month | 26 | Day |
Last modified on
| 2023 | Year | 08 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055203
