UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056481 |
|---|---|
| Receipt number | R000064544 |
| Scientific Title | A multi-center retrospective observation study on the relationship between the root and mandibular canal in the development of postoperative nerve paralysis in extracted Mandibular Wisdom Teeth |
| Date of disclosure of the study information | 2024/12/17 |
| Last modified on | 2024/12/17 21:39:27 |
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Basic information
Public title
A multi-center retrospective observation study on the relationship between the root and mandibular canal in the development of postoperative nerve paralysis in extracted Mandibular Wisdom Teeth
Acronym
Retrospective study on the relationship between the root and mandibular canal in the development of postoperative nerve paralysis in extracted Mandibular Wisdom Teeth
Scientific Title
A multi-center retrospective observation study on the relationship between the root and mandibular canal in the development of postoperative nerve paralysis in extracted Mandibular Wisdom Teeth
Scientific Title:Acronym
Retrospective study on the relationship between the root and mandibular canal in the development of postoperative nerve paralysis in extracted Mandibular Wisdom Teeth
Region
| Japan |
Condition
Condition
Wisdom tooth
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study will identify anatomical conditions that are at high risk for the development of hypersensitivity (association of the wisdom tooth root with the mandibular canal).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Onset of nerve paralysis in each case and the degree of mandibular canal deformity caused by the root of the wisdom tooth and whether it is caused by the position of the wisdom tooth root and mandibular canal (buccal, lingual, subapical, and interdental canal).
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(i) Cases with mandibular wisdom teeth extracted at the study institution between April 1, 2018 and March 31, 2021.
(ii) Cases that are 20 years of age or older.
Key exclusion criteria
(1) Cases in which sufficient information cannot be obtained due to poor entries in the medical information record.
(2) Cases in which a CT scan was not taken before surgery.
(3) Cases in which a cyst or tumor exists with the wisdom tooth and is in contact with the mandibular canal.
(4) Cases in which patients developed hypersensitivity prior to extraction of the wisdom tooth.
Target sample size
3727
Research contact person
Name of lead principal investigator
| 1st name | Hiromasa |
| Middle name | |
| Last name | Fukushima |
Organization
Nagasaki University Hospital
Division name
Department of Oral surgery
Zip code
852-8588
Address
1-7-1, sakamoto, nagasaki, Japan
TEL
095-819-7698
naruse12@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Hiromasa |
| Middle name | |
| Last name | Fukushima |
Organization
Nagasaki University Hospital
Division name
Oral surgery
Zip code
852-8588
Address
1-7-1, sakamoto, nagasaki, Japan.
TEL
095-819-7698
Homepage URL
naruse12@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki University
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
Nagasaki University
Address
1-7-1, sakamoto, nagasaki, Japan.
Tel
0958197698
naruse12@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 | 12 | Month | 17 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 12 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 12 | Month | 17 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | 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 | 12 | Month | 17 | Day |
Last modified on
| 2024 | Year | 12 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064544
