UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052019 |
|---|---|
| Receipt number | R000059382 |
| Scientific Title | A retrospective observational study on the treatment and prevention of drug-related osteonecrosis of the jaw |
| Date of disclosure of the study information | 2023/08/28 |
| Last modified on | 2023/08/28 11:16:03 |
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Basic information
Public title
A retrospective observational study on the treatment and prevention of drug-related osteonecrosis of the jaw
Acronym
A retrospective observational study on the treatment and prevention of drug-related osteonecrosis of the jaw
Scientific Title
A retrospective observational study on the treatment and prevention of drug-related osteonecrosis of the jaw
Scientific Title:Acronym
A retrospective observational study on the treatment and prevention of drug-related osteonecrosis of the jaw
Region
| Japan |
Condition
Condition
drug-related osteonecrosis of the jaw
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
1) To examine the appropriate treatment of MRONJ based on the cure rate by treatment method.
2) To examine the incidence of MRONJ in ARA-treated patients with teeth that are a source of infection, and to determine whether extraction of such teeth is preferable to prevent MRONJ.
3) To examine the difference in clinical and imaging features and treatment course between MRONJ caused by BP and MRONJ caused by DMB.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Clinical course of MRONJ patients
Number of days from the date of the first visit to the occurrence of the event with healing as the event for MRONJ patients (healing is defined as the time when the attending physician determines that all clinical symptoms, including bone exposure, have resolved)
MRONJ onset in non-MRONJ patients
Number of days from the date of the first visit to the occurrence of the event, where event is defined as MRONJ onset (or relapse)
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
1) MRONJ patients aged 18 years or older who visited Nagasaki University Hospital Dentistry from January 1, 2011 to April 30, 2023.
2) Non-MRONJ patients aged 18 years or older who visited Nagasaki University Hospital Dentistry from January 1, 2011 to June 30, 2023 who received high-dose ARA as a comparison subject.
Key exclusion criteria
Patients who have been out of the hospital for less than one month since the initial visit.
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Mitsunobu |
| Middle name | |
| Last name | Otsuru |
Organization
Nagasaki University
Division name
oralsurgery
Zip code
852-8588
Address
1-7-1 Sakamoto Nagasaki
TEL
0958197698
ootsuru@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Mitsunobu |
| Middle name | |
| Last name | Otsuru |
Organization
Nagasaki university
Division name
oralsurgery
Zip code
852-8588
Address
1-7-1 Sakamoto Nagasaki
TEL
00958197698
Homepage URL
ootsuru@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki University
Institute
Department
Personal name
Effective of cancer treatment on the worsening of periodontal disease and dental caries
Funding Source
Organization
non
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Effective of cancer treatment on the worsening of periodontal disease and dental caries
Other related organizations
Co-sponsor
Effective of cancer treatment on the worsening of periodontal disease and dental caries
Name of secondary funder(s)
Effective of cancer treatment on the worsening of periodontal disease and dental caries
IRB Contact (For public release)
Organization
Nagasaki University Clinical Trial Review Committee
Address
1-7-1 Sakamoto Nagasaki
Tel
0958197698
kenkyujim-ngs@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
| 2023 | Year | 08 | Month | 28 | 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
| 2011 | Year | 01 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Patient background at initial visit: gender, age, MRONJ status (if yes, MRONJ stage, MRONJ site), smoking history, diabetes, steroids/immunosuppressive drugs, type of ARA, duration of ARA administration, whether and how long off drugs
Clinical findings at initial visit: bone exposure, fistula, gingival infection (swelling, pus, redness)
Clinical examination at initial visit: white blood cell count, neutrophils, lymphocytes, albumin, creatinine
Imaging at initial examination: osteolysis, osteolysis, periosteal reaction, osteosclerosis (CT above)
Number of remaining teeth, root apex lesions, alveolar bone resorption, periodontal ligament cavity enlargement, alveolar hard line thickening, peri-root bone sclerosis (above: panorama)
Signal intensity change and range (MR)
Clinical course: treatment, presence/absence of MRONJ onset (recurrence), location and timing
Management information
Registered date
| 2023 | Year | 08 | Month | 28 | Day |
Last modified on
| 2023 | Year | 08 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059382
