UMIN-CTR Clinical Trial

Basic information
Public title	Multicenter retrospective observational study on the relationship between the development of drug-related osteonecrosis of the jaw and denture use
Acronym	Multicenter retrospective observational study on the relationship between the development of drug-related osteonecrosis of the jaw and denture use
Scientific Title	Multicenter retrospective observational study on the relationship between the development of drug-related osteonecrosis of the jaw and denture use
Scientific Title:Acronym	Multicenter retrospective observational study on the relationship between the development of drug-related osteonecrosis of the jaw and denture use
Region	Japan

Condition
Condition	Medication-related Osteonecrosis fo the Jaws
Classification by specialty	Oral surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	clarify the risk factor of MRONJ
Basic objectives2	Others
Basic objectives -Others	Establish the way of the prevention
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	clarify the risk factor of MRONJ
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	MRONJ patients who visited each participating facility from April 2011 to March 2021/
Key exclusion criteria	1, The patient not take panorama X-ray photo and CT. 2, The patient who can not identify the site of onset from medical records. 3, The patients who refuse this study.
Target sample size	420

Research contact person
Name of lead principal investigator	1st name YUKI Middle name Last name SAKAMOTO
Organization	Kansai Medical University Medical Center
Division name	Dentistry and Oral Surgery
Zip code	570-8507
Address	10-15 Fumizonocho Moriguchishi Osaka
TEL	06-6993-9421
Email	s.yukioutdoor@gmail.com

Public contact
Name of contact person	1st name YUKI Middle name Last name SAKAMOTO
Organization	Kansai Medical University Medical Center
Division name	Dentistry and Oral Surgery
Zip code	570-8507
Address	10-15 Fumizonocho Moriguchishi Osaka
TEL	06-6993-9421
Homepage URL
Email	s.yukioutdoor@gmail.com

Sponsor
Institute	Kansai Medical University Medical Center
Institute
Department

Funding Source
Organization	Kansai Medical University Medical Center
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor	Department of Dentistry and Oral Surgery, Kansai Medical University Hospital Nagasaki University Hospital
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Kansai Medical University Medical Center
Address	10-15 Fumizonocyo Moriguchishi Osaka
Tel	06-6993-9421
Email	s.yukioutdoor@gmail.com

Secondary IDs
Secondary IDs	YES
Study ID_1	UMIN000040560
Org. issuing International ID_1	Nagasaki University
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2022 Year 08 Month 19 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	420
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	2022 Year 05 Month 23 Day
Date of IRB	2022 Year 06 Month 27 Day
Anticipated trial start date	2022 Year 07 Month 01 Day
Last follow-up date	2023 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	age, sex, Body weight, height, MNI, primary disease, smoking, diabetes, steroid, leukocytes, albumin, creatinine, anti-resorptive agent, duration of administration, site, trigger, CT findings, treatment

Management information
Registered date	2022 Year 08 Month 16 Day
Last modified on	2022 Year 08 Month 16 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055462