UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000022479
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Institute Matsumoto Dental University
Institute
Department

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
URL(English) https://upload.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


Contact us.