UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000035258
Receipt number 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 15:06:06

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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 or person

Institute

Nagasaki University Hospital

Institute

Department

Personal name



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

Value
https://center6.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