UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053683 |
|---|---|
| Receipt number | R000061263 |
| Scientific Title | Development of a biocompatible sedation method based on oxytocin in the brain |
| Date of disclosure of the study information | 2024/03/01 |
| Last modified on | 2025/08/25 17:49:21 |
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Basic information
Public title
Development of a biocompatible sedation method based on oxytocin in the brain
Acronym
Development of a biocompatible sedation method based on oxytocin in the brain
Scientific Title
Development of a biocompatible sedation method based on oxytocin in the brain
Scientific Title:Acronym
Brain oxytocin sedation
Region
| Japan |
Condition
Condition
oral diseases
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To test the extent to which oxytocin in the human brain influences the onset of sedation by quantitatively measuring oxytocin concentrations.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1) Oxytocin concentration in saliva
2) Rate of change in parasympathetic nervous system frequency
3) Rate of change in the rate of appearance of alpha waves in the frontal EEG
Key secondary outcomes
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 undergoing dental treatment under intravenous sedation or laughing gas inhalation sedation at the Department of Comprehensive Special Dentistry of Nagasaki University Hospital or Nagasaki Prefectural Oral Health Center
(2) Patients over 18 years old
(3) Patients who have obtained consent from the patient or a surrogate (when it is deemed difficult to provide appropriate IC to the patient).
Key exclusion criteria
(1) Patients for whom saliva sampling is not possible before sedation
(2) Patients for whom it is difficult to attach EEG electrodes
(3) 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
30
Research contact person
Name of lead principal investigator
| 1st name | Terumi |
| Middle name | |
| Last name | Ayuse |
Organization
Nagasaki University Hospital
Division name
Special Care Dentistory
Zip code
8528588
Address
1-7-1 Sakamoto, Nagasaki, Japan
TEL
0958197717
ttagawa@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Terumi |
| Middle name | |
| Last name | Ayuse |
Organization
Nagasaki University Hospital
Division name
Special Care Dentistory
Zip code
8528588
Address
1-7-1 Sakamoto, Nagasaki, Japan
TEL
0958197717
Homepage URL
ttagawa@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki University Hospital
Institute
Department
Personal name
Funding Source
Organization
Japanese Society for Disability and OralHealth
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
Nagasaki University Hospital Clinical Research Ethics Committee
Address
1-7-1 Sakamoto, Nagasaki, Japan
Tel
0958197229
gaibushikin@ml.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
| 2024 | Year | 03 | Month | 01 | 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
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 07 | Month | 23 | Day |
Anticipated trial start date
| 2024 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2024 | Year | 02 | Month | 22 | Day |
Last modified on
| 2025 | Year | 08 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061263
