UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063046 |
|---|---|
| Receipt number | R000072170 |
| Scientific Title | A Retrospective Study on the Association Between CT Findings and Treatment Course in Medication-Related Osteonecrosis of the Jaw |
| Date of disclosure of the study information | 2026/09/25 |
| Last modified on | 2026/09/24 19:18:11 |
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Basic information
Public title
A Retrospective Study on the Association Between CT Findings and Treatment Course in Medication-Related Osteonecrosis of the Jaw
Acronym
A Study on CT Findings and Treatment Course in Medication-Related Osteonecrosis of the Jaw
Scientific Title
A Retrospective Study on the Association Between CT Findings and Treatment Course in Medication-Related Osteonecrosis of the Jaw
Scientific Title:Acronym
A Study on CT Findings and Treatment Course in MRONJ
Region
| Japan |
Condition
Condition
Medication-Related Osteonecrosis of the Jaw (MRONJ)
Classification by specialty
| Oral surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to retrospectively investigate the association between pre-treatment CT imaging findings and treatment outcomes in patients with medication-related osteonecrosis of the jaw (MRONJ). The study also aims to collect basic data for proposing a new qualitative classification system for MRONJ.
Basic objectives2
Others
Basic objectives -Others
This study will retrospectively investigate the association between pre-treatment CT imaging findings and treatment outcomes in patients with medication-related osteonecrosis of the jaw (MRONJ). The CT imaging findings to be evaluated will include the presence or absence of sequestrum separation, the extent of osteolysis, the presence and pattern of periosteal reaction, and the presence or absence of mixed-type osteosclerosis. The associations between these imaging findings and MRONJ healing and time to healing will be analyzed. Based on the findings, this study aims to collect basic data for proposing a new qualitative classification system for MRONJ.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
MRONJ healing and time to healing
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with medication-related osteonecrosis of the jaw (MRONJ) who first visited the Department of Oral Surgery, Nagasaki University Hospital between April 1, 2011 and March 31, 2024.
Patients who underwent pre-treatment CT imaging.
Key exclusion criteria
Patients who were lost to follow-up before 3 months after surgery.
Target sample size
412
Research contact person
Name of lead principal investigator
| 1st name | Hideto |
| Middle name | |
| Last name | Imura |
Organization
Nagasaki University Hospital
Division name
Department of Oral and Maxillofacial Surgery
Zip code
852-8501
Address
1-7-1 Sakamoto, Nagasaki, Nagasaki, Japan
TEL
095-819-7745
h-imura@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Hideto |
| Middle name | |
| Last name | Imura |
Organization
Nagasaki University Hospital
Division name
Department of Oral and Maxillofacial Surgery
Zip code
852-8501
Address
1-7-1 Sakamoto, Nagasaki, Nagasaki, Japan
TEL
095-819-7745
Homepage URL
h-imura@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
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, Nagasaki, Japan
Tel
095-819-7256
chiken_jimu@ml.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 | 25 | 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
| 2026 | Year | 07 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 10 | Month | 01 | 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 | 24 | Day |
Last modified on
| 2026 | Year | 09 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072170
