UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056002 |
|---|---|
| Receipt number | R000064001 |
| Scientific Title | Assessment of Postoperative Pain After Le Fort I Osteotomy and Mandibular Sagittal Split Ramus Osteotomy |
| Date of disclosure of the study information | 2024/10/31 |
| Last modified on | 2024/10/31 14:14:55 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Assessment of Postoperative Pain After Le Fort I Osteotomy and Mandibular Sagittal Split Ramus Osteotomy
Acronym
Assessment of Postoperative Pain After Le Fort I Osteotomy and Mandibular Sagittal Split Ramus Osteotomy
Scientific Title
Assessment of Postoperative Pain After Le Fort I Osteotomy and Mandibular Sagittal Split Ramus Osteotomy
Scientific Title:Acronym
Assessment of Postoperative Pain After Le Fort I Osteotomy and Mandibular Sagittal Split Ramus Osteotomy
Region
| Japan |
Condition
Condition
jaw deformity
Classification by specialty
| Anesthesiology | Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to evaluate postoperative pain in patients with jaw deformities undergoing bimaxillary osteotomy, including Le Fort I osteotomy and sagittal split ramus osteotomy, to establish more effective postoperative pain management strategies.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Numerical Rating Scale
Key secondary outcomes
patient background information, surgical and anesthesia records
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
Patients with jaw deformity undergoing Le Fort I and sagittal split ramus osteotomy under general anesthesia
Key exclusion criteria
Patients with intellectual disabilities and those who have difficulty responding to the questionnaire.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Shigeru |
| Middle name | |
| Last name | Maeda |
Organization
Graduate School of Medical and Dental Science, Institute of Science Tokyo
Division name
Department of Dental Anesthesiology
Zip code
113-8549
Address
1-5-45 Yushima, Bunkyo-Ku, Tokyo
TEL
03-5803-5548
maedas.daop@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Shigeru |
| Middle name | |
| Last name | Maeda |
Organization
Graduate School of Medical and Dental Science, Institute of Science Tokyo
Division name
Department of Dental Anesthesiology
Zip code
113-8549
Address
1-5-45 Yushima, Bunkyo-Ku, Tokyo
TEL
03-5803-5548
Homepage URL
maedas.daop@tmd.ac.jp
Sponsor or person
Institute
Institute of Science Tokyo
Institute
Department
Personal name
Funding Source
Organization
Institute of Science Tokyo
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
Institute of Science Tokyo
Address
1-5-45 Yushima, Bunkyo-Ku, Tokyo
Tel
03-5803-5548
maedas.daop@tmd.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
東京科学大学病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 10 | Month | 31 | 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
200
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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 01 | Month | 22 | Day |
Date of IRB
| 2024 | Year | 01 | Month | 22 | Day |
Anticipated trial start date
| 2024 | Year | 01 | Month | 22 | 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
The purpose of this study is to assess postoperative pain following Le Fort I osteotomy and sagittal split ramus osteotomy and to develop more effective pain management strategies.
Management information
Registered date
| 2024 | Year | 10 | Month | 31 | Day |
Last modified on
| 2024 | Year | 10 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064001
