UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000022479
Receipt number R000025900
Scientific Title Efficacy of platelet rich fibrin (PRF)for the prevention and the treatment of Medication Related Osteonecrosis of the Jaw(MRONJ)
Date of disclosure of the study information 2016/06/01
Last modified on 2019/02/10 14:00:06

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Basic information

Public title

Efficacy of platelet rich fibrin (PRF)for the prevention and the treatment of Medication Related Osteonecrosis of the Jaw(MRONJ)

Acronym

Efficacy of PRF for prevention/treatment of MRONJ

Scientific Title

Efficacy of platelet rich fibrin (PRF)for the prevention and the treatment of Medication Related Osteonecrosis of the Jaw(MRONJ)

Scientific Title:Acronym

Efficacy of PRF for prevention/treatment of MRONJ

Region

Japan


Condition

Condition

Medication Related Osteonecrosis of the Jaw

Classification by specialty

Dental medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To establish preventive method and surgecal management protocol for medication related osteonectoris of the jaw.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Presence of bone exposure. (For preventive and surgical treatment studies, the result will be evaluated at three and twelve months after surgery, respectively).

Key secondary outcomes

Presence of inflammation
Presence and level of pain
Presence of pus discharge
Presence of external fistula
(For preventive and surgical treatment studies, the result will be evaluated at three and twelve months after surgery, respectively).


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Historical

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

No need to know


Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Other

Interventions/Control_1

PRF is placed at bone exposure area and the wound will be closed with a nylon suture.

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

1. Preventive treatment protocol
Patients, who subscribed medications which affect bone metabolism, for the treatment of malignant tumor (ex. bisphosphonate, anti-RANKL ab) but not having MRONJ and need to have an oral surgery (ex. tooth extraction).
Age 20 or older.
Patients with good oral hygene.
Patients who can obtain written informed consent.
2. Surgical treatment protocol
MRONJ patients who require surgical treatment (ex. removal of necrotic bone).
Diagnosis of MRONJ should be based on the position paper by AAMOS (2014) as follows:
(Definition:
Patients may be considered to have MRONJ if all of the following characteristics are present:
1. Current or previous treatment with antiresorptive or antiangiogenic agents;
2. Exposed bone or bone that can be probed through an intraoral or extraoral fistula(e) in the maxillofacial region that has persisted for more than eight weeks; and
3. No history of radiation therapy to the jaws or obvious metastatic disease to the jaws.)
Age 20 or older.
Patients with good oral hygene.
Patients who can obtain written informed consent.

Key exclusion criteria

Patients with serious endocrine metabolic diseases and autoimmune diseases.
Patients with sepsis or potential sepsis.
Patients with hematologic diseases, blood disorders, blood coagulation disorders and liver diseases and having difficulty of transplantation.
Positive for any of syphilis, HBV antibody, HCV antibody, HIV antibody and HTLV-1 antibody.
Patients with transmissible spongiform encephalopathy, potent transmissible spongiform encephalopathy or dementia.
Patients with genetic diseases including sclerosing lesion of bone.
Any other conditions that the dentists in charge consider inappropriate.

Target sample size

10


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hideaki Kagami

Organization

Matsumoto Dental University

Division name

Department of Oral and Maxillofacial Surgery

Zip code


Address

1780 Gobara, Hirooka, Shiojiri, Nagano, 399-0781 Japan

TEL

0263-51-2066

Email

hideaki.kagami@mdu.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Hideaki Kagami

Organization

Matsumoto Dental University

Division name

Department of Oral and Maxillofacial Surgery

Zip code


Address

1780 Gobara, Hirooka, Shiojiri, Nagano, 399-0781 Japan

TEL

0263-51-2066

Homepage URL


Email

hideaki.kagami@mdu.ac.jp


Sponsor or person

Institute

Matsumoto Dental University

Institute

Department

Personal name



Funding Source

Organization

Matsumoto Dental University

Organization

Division

Category of Funding Organization

Other

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 06 Month 01 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


Results

So far, two patients were enrolled in this clinical study and PRF was administered sumultaneously at the time of necrotic bone removal (preventive purpose). In both patients, the region was healed and no recurrence was observed during the observation period.

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

Terminated

Date of protocol fixation

2016 Year 02 Month 01 Day

Date of IRB


Anticipated trial start date

2016 Year 06 Month 01 Day

Last follow-up date

2019 Year 01 Month 31 Day

Date of closure to data entry

2019 Year 03 Month 31 Day

Date trial data considered complete

2019 Year 03 Month 31 Day

Date analysis concluded

2019 Year 03 Month 31 Day


Other

Other related information



Management information

Registered date

2016 Year 05 Month 26 Day

Last modified on

2019 Year 02 Month 10 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025900


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name