UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048680 |
|---|---|
| Receipt number | R000055462 |
| Scientific Title | Multicenter retrospective observational study on the relationship between the development of drug-related osteonecrosis of the jaw and denture use |
| Date of disclosure of the study information | 2022/08/19 |
| Last modified on | 2022/08/16 16:49:02 |
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Basic information
Public title
Multicenter retrospective observational study on the relationship between the development of drug-related osteonecrosis of the jaw and denture use
Acronym
Multicenter retrospective observational study on the relationship between the development of drug-related osteonecrosis of the jaw and denture use
Scientific Title
Multicenter retrospective observational study on the relationship between the development of drug-related osteonecrosis of the jaw and denture use
Scientific Title:Acronym
Multicenter retrospective observational study on the relationship between the development of drug-related osteonecrosis of the jaw and denture use
Region
| Japan |
Condition
Condition
Medication-related Osteonecrosis fo the Jaws
Classification by specialty
| Oral surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
clarify the risk factor of MRONJ
Basic objectives2
Others
Basic objectives -Others
Establish the way of the prevention
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
clarify the risk factor of MRONJ
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
| 18 | years-old | < |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
MRONJ patients who visited each participating facility from April 2011 to March 2021/
Key exclusion criteria
1, The patient not take panorama X-ray photo and CT.
2, The patient who can not identify the site of onset from medical records.
3, The patients who refuse this study.
Target sample size
420
Research contact person
Name of lead principal investigator
| 1st name | YUKI |
| Middle name | |
| Last name | SAKAMOTO |
Organization
Kansai Medical University Medical Center
Division name
Dentistry and Oral Surgery
Zip code
570-8507
Address
10-15 Fumizonocho Moriguchishi Osaka
TEL
06-6993-9421
s.yukioutdoor@gmail.com
Public contact
Name of contact person
| 1st name | YUKI |
| Middle name | |
| Last name | SAKAMOTO |
Organization
Kansai Medical University Medical Center
Division name
Dentistry and Oral Surgery
Zip code
570-8507
Address
10-15 Fumizonocho Moriguchishi Osaka
TEL
06-6993-9421
Homepage URL
s.yukioutdoor@gmail.com
Sponsor or person
Institute
Kansai Medical University Medical Center
Institute
Department
Personal name
Funding Source
Organization
Kansai Medical University Medical Center
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Department of Dentistry and Oral Surgery, Kansai Medical University Hospital
Nagasaki University Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kansai Medical University Medical Center
Address
10-15 Fumizonocyo Moriguchishi Osaka
Tel
06-6993-9421
s.yukioutdoor@gmail.com
Secondary IDs
Secondary IDs
YES
Study ID_1
UMIN000040560
Org. issuing International ID_1
Nagasaki University
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 08 | Month | 19 | 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
420
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
Completed
Date of protocol fixation
| 2022 | Year | 05 | Month | 23 | Day |
Date of IRB
| 2022 | Year | 06 | Month | 27 | Day |
Anticipated trial start date
| 2022 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
age, sex, Body weight, height, MNI, primary disease, smoking, diabetes, steroid, leukocytes, albumin, creatinine, anti-resorptive agent, duration of administration, site, trigger, CT findings, treatment
Management information
Registered date
| 2022 | Year | 08 | Month | 16 | Day |
Last modified on
| 2022 | Year | 08 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055462
