UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061771 |
|---|---|
| Receipt number | R000070440 |
| Scientific Title | Analysis of the relationship and mechanisms between dental anxiety and autonomic nervous system responses in dental phobia |
| Date of disclosure of the study information | 2026/06/02 |
| Last modified on | 2026/06/02 16:41:13 |
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Basic information
Public title
Analysis of the relationship and mechanisms between dental anxiety and autonomic nervous system responses in dental phobia
Acronym
Analysis of the relationship and mechanisms between dental anxiety and autonomic nervous system responses in dental phobia
Scientific Title
Analysis of the relationship and mechanisms between dental anxiety and autonomic nervous system responses in dental phobia
Scientific Title:Acronym
Analysis of the relationship and mechanisms between dental anxiety and autonomic nervous system responses in dental phobia
Region
| Japan |
Condition
Condition
the impacted mandibular third molar
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to create a safe dental treatment environment under intravenous sedation for patients who are anxious about dental treatment by analyzing the relationship between patients' pre-operative anxiety and autonomic nervous system fluctuations during sedation. The results of this study may suggest that conducting psychological tests before dental treatment may allow for the prediction of autonomic nervous system fluctuations during intravenous sedation, potentially leading to the establishment of a safe dental treatment environment.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
STAI-S
Key secondary outcomes
LF/HF, HF, HR, SBP, MDAS,STAI-T
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
| 20 | years-old | <= |
Age-upper limit
| 40 | years-old | >= |
Gender
Female
Key inclusion criteria
Patients who require extraction of the impacted mandibular third molar
Key exclusion criteria
Patients with a history of cardiovascular disease, diabetes, or other conditions affecting the autonomic nervous system, smokers, and patients taking medications.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Kaoru |
| Middle name | |
| Last name | Yamashita |
Organization
Field of Oral and Maxillofacial Rehabilitation, Advanced Therapeutics Course, Graduate School of Medical and Dental Sciences, Kagoshima University
Division name
Department of Dental Anesthesiology
Zip code
890-8544
Address
8-35-1 Sakuragaoka, Kagoshima
TEL
099-275-6288
kaorun@dent.kagoshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Kaoru |
| Middle name | |
| Last name | Yamashita |
Organization
Graduate School of Medical and Dental Sciences, Kagoshima University
Division name
Department of Dental Anesthesiology
Zip code
890-0075
Address
8-35-1 Sakuragaoka, Kagoshima
TEL
0992756288
Homepage URL
kaorun@dent.kagoshima-u.ac.jp
Sponsor or person
Institute
Kagoshima University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
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
Clinical Research Management Center of Kagoshima University Hospital
Address
8-35-1 Sakuragaoka, Kagoshima
Tel
099-275-6624
crmc@m2.kufm.kagoshima-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 | 06 | Month | 02 | 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
40
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
| 2023 | Year | 03 | Month | 15 | Day |
Date of IRB
| 2023 | Year | 03 | Month | 15 | Day |
Anticipated trial start date
| 2023 | Year | 03 | Month | 15 | Day |
Last follow-up date
| 2032 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We observe fluctuations in autonomic nervous system activity and changes in psychological state during intravenous sedation.
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=R000070440
