UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060033 |
|---|---|
| Receipt number | R000068620 |
| Scientific Title | A study on the relationship of trust between patients with dental phobia and dental professionals |
| Date of disclosure of the study information | 2026/01/19 |
| Last modified on | 2025/12/10 09:56:51 |
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Basic information
Public title
A study on the relationship of trust between patients with dental phobia and dental professionals
Acronym
A study on the relationship of trust between patients with dental phobia and dental professionals
Scientific Title
A study on the relationship of trust between patients with dental phobia and dental professionals
Scientific Title:Acronym
A study on the relationship of trust between patients with dental phobia and dental professionals
Region
| Japan |
Condition
Condition
dental phobia
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
One of the reasons why patients with dental phobia avoid treatment is their fear of and distrust in dental professionals.
In order to overcome fundamental dental anxiety, this study objectively evaluates patients' trust in dental professionals and their adaptation to dental treatment.
Basic objectives2
Others
Basic objectives -Others
Assessment of adaptation to dental treatment
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Assessment of changes in salivary stress-related hormone levels
(Oxytocin,Cortisol)
Key secondary outcomes
1)Assessment of changes in MDAS scores(Modified Dental Anxiety Scale (Japanese version))
2)Changes in LF/HF ratio and relaxation level analyzed by facial expression analysis
3)Rate of change in the rate of appearance of alpha waves in the frontal EEG
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
1)Patients with severe dental phobia receiving periodontal treatment at Nagasaki University Hospital
2)Patients with an MDAS score of 19 or higher
3)Patients aged 18 years or older
Key exclusion criteria
1)Patients with extremely high levels of dental phobia who are unable to complete questionnaires, provide saliva samples, or undergo facial imaging and EEG measurements
2)Other cases in which the Principal Investigator and the Principal Investigator deem the subject to be inappropriate as a research subject will be excluded from the study
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | Kaori |
| Middle name | |
| Last name | Yamaguchi |
Organization
Nagasaki University Hospital
Division name
Department of Special Care Dentistry
Zip code
852-8501
Address
1-7-1 Sakamoto , Nagasaki
TEL
095-819-7717
yamaguchi.k925@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Kaori |
| Middle name | |
| Last name | Yamaguchi |
Organization
Nagasaki University Hospital
Division name
Department of Special Care Dentistry
Zip code
852-8501
Address
1-7-1 Sakamoto , Nagasaki
TEL
095-819-7717
Homepage URL
yamaguchi.k925@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki University Hospital
Institute
Department
Personal name
Funding Source
Organization
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
Nagasaki University Hospital
Address
1-7-1 Sakamoto , Nagasaki
Tel
095-819-7717
yamaguchi.k925@nagasaki-u.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
| 2026 | Year | 01 | Month | 19 | 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
| 2025 | Year | 12 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 01 | Month | 19 | Day |
Last follow-up date
| 2027 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
An observational study on the relationship of trust between patients with dental phobia and dental professionals
Management information
Registered date
| 2025 | Year | 12 | Month | 10 | Day |
Last modified on
| 2025 | Year | 12 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068620
