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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000035258
Receipt No. 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

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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
Email 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
Email gaibushikin@ml.nagasaki-u.ac.jp

Sponsor
Institute Nagasaki University Hospital
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040167

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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