UMIN-CTR Clinical Trial

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

Medication related osteonecrosis of the jaw

Classification by specialty

Oral surgery

Classification by malignancy

Others

Genomic information

NO

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

Primary outcomes

The presence or absence of MRONJ

Key secondary outcomes

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Kobe University Graduate School of Medicine

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2016

Year

04

Month

01

Day

URL releasing protocol

Publication of results

Partially published

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

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 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.

Registered date

2016

Year

03

Month

18

Day

Last modified on

2018

Year

08

Month

14

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024841