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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000022479
Enrollment
10
Registered
2016-06-01
Start date
2016-06-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Medication Related Osteonecrosis of the Jaw

Interventions

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

Sponsors

Matsumoto Dental University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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.

Exclusion criteria

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.

Design outcomes

Primary

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

Secondary

MeasureTime frame
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).

Countries

Japan

Contacts

Public ContactHideaki Kagami

Matsumoto Dental University Department of Oral and Maxillofacial Surgery

hideaki.kagami@mdu.ac.jp0263-51-2066

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026