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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000021543
Receipt No. R000024841
Scientific Title The retrospective study of risk factors of Medication related osteonecrosis of the jaw (MRONJ) after oral surgery
Date of disclosure of the study information 2016/04/01
Last modified on 2018/08/14

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Basic information
Public title The retrospective study of risk factors of Medication related osteonecrosis of the jaw (MRONJ) after oral surgery
Acronym The study of risk factors of MRONJ after oral surgery
Scientific Title The retrospective study of risk factors of Medication related osteonecrosis of the jaw (MRONJ) after oral surgery
Scientific Title:Acronym The study of risk factors of MRONJ after oral surgery
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 The aim of this retrospective study is to investigate the multivariate relationships among various risk factors including drug holiday and the content of treatment for MRONJ patients.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The presence or absence 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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria The subjects is the patients with bisphosphonate drug or anti-RANKL monoclonal antibody drug receiving oral surgery at the Department of Oral and Maxillofacial Surgery, Kobe University Graduate School of Medicine and the institutions of research collaboration.
Key exclusion criteria Patients who principal investigator has determined to be inappropriate as a subject.
Target sample size 600

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takumi Hasegawa
Organization Kobe University Graduate School of Medicine
Division name Department of Oral and Maxillofacial Surgery
Zip code
Address 7-5-1, Kusunoki-cho, Chuo-ku, Kobe 650-0017, Japan
TEL 078-382-6213
Email hasetaku@med.kobe-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takumi Hasegawa
Organization Kobe University Graduate School of Medicine
Division name Department of Oral and Maxillofacial Surgery
Zip code
Address 7-5-1, Kusunoki-cho, Chuo-ku, Kobe 650-0017, Japan
TEL 078-382-6213
Homepage URL
Email hasetaku@med.kobe-u.ac.jp

Sponsor
Institute Kobe University Graduate School of Medicine
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
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
2016 Year 04 Month 01 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
2016 Year 03 Month 01 Day
Date of IRB
Anticipated trial start date
2016 Year 04 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 Subjects
Between January 2008 and December 2015, the subjects is the patients with bisphosphonate drug or anti-RANKL monoclonal antibody drug receiving oral surgery at the Department of Oral and Maxillofacial Surgery, Kobe University Graduate School of Medicine and the institutions of research collaboration.
Methods
All of the patients were investigated with regard to demographics, medical background, type and duration of BP use, whether or not they underwent a discontinuation of BP before tooth extraction, the duration of such discontinuation, additional surgical procedures such as incision, bone removal, root amputation and suturing, whether antibiotics were administered before extraction, the condition of the bone around the root of the tooth, the duration of follow-up, primary wound healing with no evident sign of infection, presence or absence of MRONJ, and stage of MRONJ.
Statistical analysis
All of the variables associated with MRONJ were introduced into a multiple logistic regression model. Forward selection methods were used, with the rejection of those variables that did not fit the model significantly. Multivariate odds ratios (ORs) and 95% confidence intervals (CIs) were also calculated for the significant signs. Avalue of p < 0.05was considered statistically significant.

Management information
Registered date
2016 Year 03 Month 18 Day
Last modified on
2018 Year 08 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024841

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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