UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061762 |
|---|---|
| Receipt number | R000070672 |
| Scientific Title | A preliminary evaluation of the feasibility, acceptability, and preventive behavioral intentions associated with the 7-day DentalGO web application |
| Date of disclosure of the study information | 2026/06/03 |
| Last modified on | 2026/06/02 21:37:18 |
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Basic information
Public title
A study of the usability of the 7-day DentalGO web application for adults who have not visited a dentist recently
Acronym
DentalGO 7-day Study
Scientific Title
A preliminary evaluation of the feasibility, acceptability, and preventive behavioral intentions associated with the 7-day DentalGO web application
Scientific Title:Acronym
DentalGO-7 Feasibility Study
Region
| Japan |
Condition
Condition
Prolonged non-attendance for dental care (no dental visit for at least two years)
Classification by specialty
| Dental medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the feasibility and acceptability of the 7-day DentalGO web application among adults who have not visited a dentist for at least two years. Feasibility and acceptability will be assessed using the 7-day completion rate, daily log completion rate, System Usability Scale (SUS) score, self-reported satisfaction, and adverse events. Exploratory assessments will examine changes in dental anxiety, oral self-care frequency, and awareness, use, and purchase intentions regarding fluoride toothpaste and xylitol gum.
Basic objectives2
Others
Basic objectives -Others
Evaluation of the feasibility and acceptability of a web-based behavioral support intervention
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Proportion of enrolled participants who complete seven days of DentalGO web application use by day 10 after the initial login (7-day completion rate)
Key secondary outcomes
Proportion of planned daily application sessions completed within 10 days after the initial login. For each participant, the daily log completion rate will be calculated as the proportion of the seven planned daily sessions that were completed.
System Usability Scale (SUS) score assessed using the post-intervention questionnaire on day 10 after the initial login.
Proportion of participants reporting "mostly satisfied" or "very satisfied" on day 10 after the initial login.
Self-reported burden assessed using the post-intervention questionnaire on day 10 after the initial login.
Number and description of adverse events reported through day 10 after the initial login and reasons for discontinuation.
Change in dental anxiety score from baseline to day 10 after the initial login.
Change in oral self-care frequency, including toothbrushing, flossing, and xylitol intake, from baseline to day 10 after the initial login.
Changes in awareness, use frequency, and purchase intentions regarding fluoride toothpaste and xylitol gum from baseline to day 10 after the initial login.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Participants will complete seven daily sessions of the 7-day DentalGO web application within 10 days after their initial login, in principle once daily. Each session is expected to take a few minutes to approximately five minutes. Participants will record whether they brushed their teeth that day, read brief educational content about oral health, fluoride, and xylitol, and answer a short quiz. If participants miss a day, they may resume using the application on a subsequent day within the 10-day period.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Participants must meet all of the following criteria:
1.Adults aged 18 years or older
2.Residents of Japan
3.No dental visit within the past two years
4.Ability to use a web browser on a smartphone or computer
5.Possession of an email address
6.Willingness to participate in the study for seven days after the initial login to the DentalGO web application
7.Provision of electronic informed consent after reviewing the study information
Key exclusion criteria
No specific exclusion criteria.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Mika |
| Middle name | |
| Last name | Kajita |
Organization
Mika Kajita, Dentist, Independent Researcher
Division name
Independent Research
Zip code
732-0052
Address
1-11-5-623, Hikarimachi, Higashi-ku, Hiroshima-shi
TEL
+358-41-797-4922
mika.kajita@dentalgo.app
Public contact
Name of contact person
| 1st name | Mika |
| Middle name | |
| Last name | Kajita |
Organization
Mika Kajita, Dentist, Independent Researcher
Division name
Independent Research
Zip code
732-0052
Address
1-11-5-623, Hikarimachi, Higashi-ku, Hiroshima-shi
TEL
+358-41-797-4922
Homepage URL
mika.kajita@dentalgo.app
Sponsor or person
Institute
Independent Research
Institute
Department
Personal name
Mika Kajita
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee for Research Involving Human Subjects, Public Health Research Foundation
Address
3F, 1-1-7 Nishi-Waseda, Shinjuku-ku, Tokyo 169-0051, Japan
Tel
03-5287-5070
rinri@phrf.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
| 2026 | Year | 06 | Month | 03 | 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
No plan to share IPD.
IPD sharing Plan description
There is no plan to share anonymized individual participant data with third parties. Only aggregated study results will be reported.
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2026 | Year | 04 | Month | 09 | Day |
Date of IRB
| 2026 | Year | 04 | Month | 10 | Day |
Anticipated trial start date
| 2026 | Year | 06 | Month | 04 | Day |
Last follow-up date
| 2026 | Year | 09 | 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
| 2026 | Year | 06 | Month | 02 | Day |
Last modified on
| 2026 | Year | 06 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070672
