UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Surgery for maxillary MRONJ with concurrent maxillary sinusitis: A multicenter retrospective observational study
Title of the study (Brief title)	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	Kohei Okuyama
Organization	Nagasaki University
Division name	Oral Surgery
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	Nagasaki University research support center
Organization	Nagasaki University research support center
Division name	Soumu-ka
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2018 Year 02 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
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