UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062900 |
|---|---|
| Receipt number | R000072017 |
| Scientific Title | Individualized risk prediction of inferior alveolar nerve injury after mandibular third molar extraction: a multicenter retrospective study using a nomogram |
| Date of disclosure of the study information | 2026/09/13 |
| Last modified on | 2026/09/13 10:52:56 |
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Basic information
Public title
Individualized risk prediction of inferior alveolar nerve injury after mandibular third molar extraction: a multicenter retrospective study using a nomogram
Acronym
Individualized risk prediction of inferior alveolar nerve injury after mandibular third molar extraction
Scientific Title
Individualized risk prediction of inferior alveolar nerve injury after mandibular third molar extraction: a multicenter retrospective study using a nomogram
Scientific Title:Acronym
Individualized risk prediction of inferior alveolar nerve injury after mandibular third molar extraction
Region
| Japan |
Condition
Condition
Mandibular third molar
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In this study, we will develop a nomogram that assigns scores to background factors, enabling the calculation of the individual probability of developing sensory impairment, and we will statistically evaluate its discrimination, calibration, and clinical utility. We believe that this study will allow for the individual assessment of the risk of postoperative sensory impairment and contribute to future oral surgery practice.
Basic objectives2
Others
Basic objectives -Others
Development of personalized risk prediction using nomograms
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Presence or absence of inferior alveolar nerve injury
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
Cases in which a mandibular wisdom tooth was extracted at the research institution between April 1, 2018, and March 31, 2021.
Cases involving patients aged 20 years or older at the time of wisdom tooth extraction.
Cases for which a panoramic X-ray image was taken.
Key exclusion criteria
Cases where a cyst or tumor is present alongside the wisdom tooth and is in contact with the mandibular canal.
Cases where sensory impairment has already developed prior to wisdom tooth extraction.
Cases where crown sectioning or a two-stage procedure has been selected.
Target sample size
3727
Research contact person
Name of lead principal investigator
| 1st name | Hiromasa |
| Middle name | |
| Last name | Fukushima |
Organization
Nagasaki University
Division name
Oral surgery
Zip code
852-8588
Address
1-7-1, sakamoto, nagasaki, Japan
TEL
0958197698
hirofuku922@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Hiromasa |
| Middle name | |
| Last name | Fukushima |
Organization
Nagasaki University
Division name
Oral surgery
Zip code
852-8588
Address
1-7-1, sakamoto, nagasaki, Japan.
TEL
0958197698
Homepage URL
hirofuku922@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki University
Institute
Department
Personal name
Funding Source
Organization
Nagasaki University
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
hirofuku922@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
| 2026 | Year | 09 | Month | 13 | 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
Open public recruiting
Date of protocol fixation
| 2026 | Year | 09 | Month | 13 | Day |
Date of IRB
| 2026 | Year | 09 | Month | 11 | Day |
Anticipated trial start date
| 2026 | Year | 09 | Month | 13 | Day |
Last follow-up date
| 2026 | Year | 12 | 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
| 2026 | Year | 09 | Month | 13 | Day |
Last modified on
| 2026 | Year | 09 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072017
