UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy of platelet rich fibrin (PRF)for the prevention and the treatment of Medication Related Osteonecrosis of the Jaw(MRONJ)
Title of the study (Brief title)	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	Hideaki Kagami
Organization	Matsumoto Dental University
Division name	Department of Oral and Maxillofacial Surgery
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	Hideaki Kagami
Organization	Matsumoto Dental University
Division name	Department of Oral and Maxillofacial Surgery
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)

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

Progress
Recruitment status	Terminated
Date of protocol fixation	2016 Year 02 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
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.
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