UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056365 |
|---|---|
| Receipt number | R000053986 |
| Scientific Title | Autonomic nervous function analysis and psychological state analysis during mandibular impacted wisdom tooth extraction by heart rate variability analysis and psychological test |
| Date of disclosure of the study information | 2024/12/05 |
| Last modified on | 2024/12/05 08:30:39 |
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Basic information
Public title
Autonomic nervous function analysis and psychological state analysis during mandibular impacted wisdom tooth extraction by heart rate variability analysis and psychological test
Acronym
Autonomic nervous function analysis and psychological state analysis during mandibular impacted wisdom tooth extraction by heart rate variability analysis and psychological test
Scientific Title
Autonomic nervous function analysis and psychological state analysis during mandibular impacted wisdom tooth extraction by heart rate variability analysis and psychological test
Scientific Title:Acronym
Autonomic nervous function analysis and psychological state analysis during mandibular impacted wisdom tooth extraction by heart rate variability analysis and psychological test
Region
| Japan | Asia(except Japan) |
Condition
Condition
impacted mandibular thirdd molar
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluate and analyze the autonomic nervous function of patients before extraction of mandibular impacted wisdom teeth using heart rate variability analysis and questionnaire table
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
LF/HF
Key secondary outcomes
HF ,HR,SBP, TMI,MDAS
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
Female patients aged 20 to 40 years with mandibular impacted wisdom tooth extraction required
Key exclusion criteria
Cases with diseases that affect autonomic nerves and brain waves
Cases with a history of smoking in the past
Patients taking medication on a regular basis
Pregnant woman
Psychosis
Other patients that the doctor deems inappropriate
Target sample size
40
Research contact person
Name of lead principal investigator
| 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
890-8544
Address
Kagoshima University, 8-35-1 Sakuragaoka, Kagoshima 890-8544, Japan.
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, Kagoshima, Japan
Division name
Department of Dental Anesthesiology
Zip code
890-8544
Address
Kagoshima University, 8-35-1 Sakuragaoka, Kagoshima 890-8544, Japan.
TEL
099-275-6288
Homepage URL
kaorun@dent.kagoshima-u.ac.jp
Sponsor or person
Institute
Graduate School of Medical and Dental Sciences, Kagoshima University, Kagoshima, Japan
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
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
Graduate School of Medical and Dental Sciences, Kagoshima University, Kagoshima, Japan
Address
Kagoshima University, 8-35-1 Sakuragaoka, Kagoshima 890-8544, Japan.
Tel
099-275-6288
kaorun@dent.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
| 2024 | Year | 12 | Month | 05 | 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
| Delay expected |
Results Delay Reason
We will fill this item in as soon as the paper is published.
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
| 2021 | Year | 08 | Month | 27 | Day |
Date of IRB
| 2021 | Year | 08 | Month | 27 | Day |
Anticipated trial start date
| 2021 | Year | 08 | Month | 27 | 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
We analyze the autonomic nervous activity of patients before the extraction of their impacted mandibular third molar.
Management information
Registered date
| 2024 | Year | 12 | Month | 05 | Day |
Last modified on
| 2024 | Year | 12 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053986
