UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053460 |
|---|---|
| Receipt number | R000059592 |
| Scientific Title | Development and validation of a clinical score to predict non-operative therapy outcomes in patients with medication related osteonecrosis of the jaw |
| Date of disclosure of the study information | 2024/01/28 |
| Last modified on | 2024/02/15 17:48:39 |
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Basic information
Public title
Development and validation of a clinical score to predict non-operative therapy outcomes in patients with medication related osteonecrosis of the jaw
Acronym
Development of a clinical score in patients with medication related osteonecrosis of the jaw
Scientific Title
Development and validation of a clinical score to predict non-operative therapy outcomes in patients with medication related osteonecrosis of the jaw
Scientific Title:Acronym
Development of a clinical score in patients with medication related osteonecrosis of the jaw
Region
| Japan |
Condition
Condition
medication related osteonecrosis of the jaw
Classification by specialty
| Oral surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Development of a clinical score to predict non-operative therapy outcomes in patients with medication related osteonecrosis of the jaw
Basic objectives2
Others
Basic objectives -Others
Validation of a clinical score to predict non-operative therapy outcomes in patients with medication related osteonecrosis of the jaw
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Uncontrollable disease
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with medication related osteonecrosis of the jaw who visited Keio University Hospital and joint research institutions between April 1, 2012 and March 31, 2023.
Key exclusion criteria
Patients under 18 years old.
Patients who were expected to receive surgical treatment from the time of their initial diagnosis.
Patients who have not had an imaging test.
Target sample size
1200
Research contact person
Name of lead principal investigator
| 1st name | Hidetaka |
| Middle name | |
| Last name | Miyashita |
Organization
Keio University School of Medicine
Division name
Department of Dentistry and Oral Surgery
Zip code
1608582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
0333531211
miyashita@keio.jp
Public contact
Name of contact person
| 1st name | kanako |
| Middle name | |
| Last name | munakata |
Organization
Keio University School of Medicine
Division name
Department of Dentistry and Oral Surgery
Zip code
1608582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
0333531211
Homepage URL
munakatakanako@keio.jp
Sponsor or person
Institute
Keio University
Institute
Department
Personal name
Funding Source
Organization
The Japanese Society of Oral and Maxillofacial Surgeons
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
Keio University Ethics Committee
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
Tel
0333531211
med-rinri-jimu@adst.keio.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
| 2024 | Year | 01 | 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
Open public recruiting
Date of protocol fixation
| 2023 | Year | 10 | Month | 03 | Day |
Date of IRB
| 2023 | Year | 10 | Month | 30 | Day |
Anticipated trial start date
| 2024 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
not applicable
Management information
Registered date
| 2024 | Year | 01 | Month | 27 | Day |
Last modified on
| 2024 | Year | 02 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059592
