UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040791 |
|---|---|
| Receipt number | R000046487 |
| Scientific Title | Histopathological and bacteriological study of medication-related osteonecrosis of the jaw using surgical specimen |
| Date of disclosure of the study information | 2020/07/20 |
| Last modified on | 2024/02/26 09:15:44 |
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Basic information
Public title
Histopathological and bacteriological study of medication-related osteonecrosis of the jaw using surgical specimen
Acronym
Histopathological and bacteriological study of medication-related osteonecrosis of the jaw using surgical specimen
Scientific Title
Histopathological and bacteriological study of medication-related osteonecrosis of the jaw using surgical specimen
Scientific Title:Acronym
Histopathological and bacteriological study of medication-related osteonecrosis of the jaw using surgical specimen
Region
| Japan |
Condition
Condition
Medication-related Osteonecrosis of the Jaws
Classification by specialty
| Oral surgery | Dental medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Establishment of treatment
Basic objectives2
Others
Basic objectives -Others
1. Determining the appropriate bone resection range
2. Risk factors associated with treatment outcome
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
1.preoperative imaging
2.histopathology of surgical specimen
3.bacteriology of surgical specimen
4.change in morphology and number of osteoclasts on surgical specimen
5.sort, administration duratio and drug holiday of antiresorptive agent
6.postoperative imaging
7.treatment results (curing) of MRONJ
8.each collected item
age, sex, primary disease, diabetes, steroid, chemotherapy, leukocytes, lymphocyte, albumin, creatinine, site, stage, trigger, treatment
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
Patients undergoing surgery for MRONJ by March 2023
Key exclusion criteria
Patients dose not have a bone sample available for the study.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Sakiko |
| Middle name | |
| Last name | Soutome |
Organization
Nagasaki University
Division name
Department of Oral Health, Medical and Dental Sciences, Graduate School of Biomed
Zip code
852-8588
Address
1-7-1 Sakamoto, Nagasaki-shi
TEL
095-819-7698
sakiko@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Sakiko |
| Middle name | |
| Last name | Soutome |
Organization
Nagasaki University
Division name
Department of Oral Health, Medical and Dental Sciences, Graduate School of Biomed
Zip code
852-8588
Address
1-7-1 Sakamoto, Nagasaki-shi
TEL
095-819-7698
Homepage URL
sakiko@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 Hospital
Address
1-7-1 Sakamoto, Nagasaki-shi
Tel
095-819-7229
gaibushikin@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
| 2020 | Year | 07 | Month | 20 | 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
No longer recruiting
Date of protocol fixation
| 2020 | Year | 06 | Month | 15 | Day |
Date of IRB
| 2020 | Year | 08 | Month | 18 | Day |
Anticipated trial start date
| 2020 | Year | 07 | Month | 20 | Day |
Last follow-up date
| 2023 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
age, sex, primary disease, diabetes, steroid, chemotherapy, anti-resorptive agent, dose, duration of administration, site, stage, trigger, treatment history, leukocytes, lymphocyte, albumin, creatinine, Panoramic and CT findings(preoperative and postoperative), hystological and bacteriological examination, treatment, extent of bone resection
Management information
Registered date
| 2020 | Year | 06 | Month | 16 | Day |
Last modified on
| 2024 | Year | 02 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046487
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
