UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053875 |
|---|---|
| Receipt number | R000061502 |
| Scientific Title | Eye tracking and brain activity analysis in dental visual stimulation tasks |
| Date of disclosure of the study information | 2024/03/15 |
| Last modified on | 2024/03/25 11:38:44 |
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Basic information
Public title
Research on visual perception patterns for dental visual stimulation tasks
Acronym
Visual perception patterns in response to dental visual stimuli
Scientific Title
Eye tracking and brain activity analysis in dental visual stimulation tasks
Scientific Title:Acronym
Brain activity for dental visual stimuli
Region
| Japan |
Condition
Condition
Individuals with dental fear
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare visual perception patterns to dental visual stimulation tasks between healthy adults and those with dental fear
Basic objectives2
Others
Basic objectives -Others
To compare visual perception patterns to dental visual stimulation tasks between healthy adults and those with dental fear
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Brain activity using near-infrared spectroscopy
Key secondary outcomes
Eye tracking measurement, Pulse rate, Galvanic skin response
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
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Other |
Interventions/Control_1
Viewing of dental visual stimulation tasks
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
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Healthy adults who have received dental treatment
Key exclusion criteria
Individuals with visual or hearing impairment
Individuals with serious hepatic, renal or cardiac disorders
Individuals taking drugs that may affect cerebral blood flow
Individuals whose dental fears are currently controlled by medication or other treatments
Target sample size
28
Research contact person
Name of lead principal investigator
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Karibe |
Organization
Nippon Dental University, School of Life Dentistry at Tokyo
Division name
Department of Pediatric Dentistry
Zip code
1028159
Address
1-9-20 Fujimi Chiyoda-ku
TEL
0332616524
h-karibe@tky.ndu.ac.jp
Public contact
Name of contact person
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Karibe |
Organization
The Nippon Dental University, School of Life Dentistry at Tokyo
Division name
Department of Pediatric Dentistry
Zip code
102-8159
Address
1-9-20 Fujimi Chiyoda-ku
TEL
0332616524
Homepage URL
h-karibe@tky.ndu.ac.jp
Sponsor or person
Institute
The Nippon Dental University, School of Life Dentistry at Tokyo
Institute
Department
Personal name
Funding Source
Organization
Scientific Research from the Japan Society for the Promotion of Science
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
The Ethics Committee of Nippon Dental University, School of Life Dentistry
Address
1-9-20 Fujimi Chiyoda-ku
Tel
0332618311
ndu-rinri@tky.ndu.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
| 2024 | Year | 03 | Month | 15 | 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
Open public recruiting
Date of protocol fixation
| 2022 | Year | 08 | Month | 25 | Day |
Date of IRB
| 2023 | Year | 08 | Month | 08 | Day |
Anticipated trial start date
| 2024 | Year | 03 | Month | 18 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 03 | Month | 15 | Day |
Last modified on
| 2024 | Year | 03 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061502
| Research Plan | |
|---|---|
| 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 |
