UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057512 |
|---|---|
| Receipt number | R000065663 |
| Scientific Title | Research of the operation under general anesthesia at the Department of Oral and Maxilofacial Surgery, Tokyo Dental College, during the COVID-19 pandemic in 2022 |
| Date of disclosure of the study information | 2025/04/05 |
| Last modified on | 2025/04/04 10:50:15 |
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Basic information
Public title
Research of the operation under general anesthesia at the Department of Oral and Maxilofacial Surgery, Tokyo Dental College, during the COVID-19 pandemic in 2022
Acronym
Research of the operation under general anesthesia at the Department of Oral and Maxilofacial Surgery, Tokyo Dental College, during the COVID-19 pandemic in 2022
Scientific Title
Research of the operation under general anesthesia at the Department of Oral and Maxilofacial Surgery, Tokyo Dental College, during the COVID-19 pandemic in 2022
Scientific Title:Acronym
Research of the operation under general anesthesia at the Department of Oral and Maxilofacial Surgery, Tokyo Dental College, during the COVID-19 pandemic in 2022
Region
| Japan |
Condition
Condition
Disease of Oral and Maxillofacial
Classification by specialty
| Oral surgery | Operative medicine | Dental medicine |
| Adult | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This research could improve the management of Oral and maxillofacial surgery at Tokyo Dental College by providing feedback on disease inclination.
The purpose of the research is also to check the difference between before the COVID-19 pandemic and after it, to consider them.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The items are gender, age, diagnosis, method of operation, operation time, the day the operation was performed, and past disease history.
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
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
| 1 | years-old | <= |
Age-upper limit
| 116 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
We adopted the patients that have experienced the operation under general anesthesia at Tokyo Dental College.
Key exclusion criteria
None.
Target sample size
644
Research contact person
Name of lead principal investigator
| 1st name | Akihiro |
| Middle name | |
| Last name | Nishiyama |
Organization
Tokyo Dental College
Division name
Department of Oral Pathobiological Science and Surgery
Zip code
101061
Address
2-9-18 Kandamisakicho Chiyoda-ku Tokyo
TEL
0352751725
nishiaki@tdc.ac.jp
Public contact
Name of contact person
| 1st name | Akihiro |
| Middle name | |
| Last name | Nishiyama |
Organization
Tokyo Dental College
Division name
Oral and Maxillofacial Surgery
Zip code
1010061
Address
2-9-18 Kandamisakicho Chiyoda-ku Tokyo
TEL
0352751725
Homepage URL
nishiaki@tdc.ac.jp
Sponsor or person
Institute
Tokyo Dental College
Institute
Department
Personal name
Funding Source
Organization
none
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
The ethics committee of Tokyo Dental College
Address
2-9-18 Kanda-Misaki cho Chiyoda-Ku Tokyo
Tel
03-6380-9114
drinri@tdc.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
| 2025 | Year | 04 | Month | 05 | Day |
Related information
URL releasing protocol
chrome-extension://efaidnbmnnnibpcajpcglclefindmkaj/https://ir.tdc.ac.jp/irucaa/bitstream/10130/6518
Publication of results
Unpublished
Result
URL related to results and publications
chrome-extension://efaidnbmnnnibpcajpcglclefindmkaj/https://ir.tdc.ac.jp/irucaa/bitstream/10130/6518
Number of participants that the trial has enrolled
644
Results
At Tokyo Dental College, there are 644 cases of operations under general anesthesia. The level of operation of Oral and maxillofacial surgery is indicated, and the levels are separated into four types.
There are 17 cases as Level 1, 338 cases as Level 2, 288 cases as Level 3, and one case as Level 4. The average bleeding of orthognathic surgery, as one representative case at Tokyo Dental College Suidoubashi Hospital, is approximately 195ml, and the operation time is four hours and twelve minutes.
Results date posted
| 2025 | Year | 04 | Month | 04 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The participants have experienced the operation under general anesthesia at Tokyo Dental College Suidoubasi Hpspital.
Participant flow
This study is retrospective in the period.
Adverse events
None.
Outcome measures
The items for this study are the number of cases, gender, age, and four types of classification according to the Japanese Oral and Maxillofacial Surgery Association. We also investigated the average of bleeding of the operations and the operation time.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2023 | Year | 07 | Month | 31 | Day |
Date of IRB
| 2023 | Year | 07 | Month | 31 | Day |
Anticipated trial start date
| 2023 | Year | 07 | Month | 31 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This Study is a retrospective study.
Management information
Registered date
| 2025 | Year | 04 | Month | 04 | Day |
Last modified on
| 2025 | Year | 04 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065663
