UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035258 |
|---|---|
| Receipt number | R000040167 |
| Scientific Title | Surgery for maxillary MRONJ with concurrent maxillary sinusitis: A multicenter retrospective observational study |
| Date of disclosure of the study information | 2018/12/14 |
| Last modified on | 2018/12/14 15:06:06 |
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Basic information
Public title
Surgery for maxillary MRONJ with concurrent maxillary sinusitis: A multicenter retrospective observational study
Acronym
Surgery for maxillary MRONJ
Scientific Title
Surgery for maxillary MRONJ with concurrent maxillary sinusitis: A multicenter retrospective observational study
Scientific Title:Acronym
Surgery for maxillary MRONJ
Region
| Japan |
Condition
Condition
Medication-related osteonecrosis of the jaw
Classification by specialty
| Oto-rhino-laryngology | Oral surgery | Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We retrospectively analyzed upper cases of medication-related osteonecrosis of the jaw to understand their clinical characteristics and identify critical factors that influence treatment outcomes, including the presence of concomitant maxillary sinusitis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Treatment outcome was defined by both clinical evaluations or CT assessments. Outcomes were divided into 2 categories: 1) Complete healing, comprising resolution of all clinical symptoms, including bone exposure; 2) Not healing, comprising reduced clinical stage, no change in clinical stage, progression, or increased clinical stage.
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
| 48 | years-old | <= |
Age-upper limit
| 89 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
All cases who were treated in participating hospitals.
Key exclusion criteria
Cases who could not be undergone surgery by systemic disorders.
Target sample size
54
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kohei Okuyama |
Organization
Nagasaki University
Division name
Oral Surgery
Zip code
Address
1-7-1, Sakamoto, Nagasaki-shi, Nagasaki-ken
TEL
095-819-7698
okuyamak@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Nagasaki University research support center |
Organization
Nagasaki University research support center
Division name
Soumu-ka
Zip code
Address
1-7-1, Sakamoto, Nagasaki-shi, Nagasaki-ken
TEL
0958197229
Homepage URL
http://www.mh.nagasaki-u.ac.jp/research/rinsho/committee/hospital_contact.html
gaibushikin@ml.nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki University Hospital
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science (JSPS)
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2018 | Year | 12 | Month | 14 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
Completed
Date of protocol fixation
| 2018 | Year | 02 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 02 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Nothing special.
Management information
Registered date
| 2018 | Year | 12 | Month | 14 | Day |
Last modified on
| 2018 | Year | 12 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040167
