Osteonecrosis Due to Drugs, Jaw Clinical Trial
Official title:
Plasma Rich in Growth Factors for Treatment of Medication Related Osteonecrosis of the Jaw: a Multicenter, Randomized, Clinical Trial
Medication related Osteonecrosis of the Jaw (MRONJ) consists of progressive destruction of
bone in the maxillofacial area. It is an established complication which occurs in patients
who take two main classes of antiresorptive drugs: Bisphosphonates (BP) and Denosumab.
PRGF is a autologous platelet-enriched plasma obtained from the patient's own blood. It
contains proteins that can influence and promote cell recruitment and its beneficial effect
could consist in improving bone and soft tissue healing. These benefits are likely to apply
to MRONJ surgery, as it is suggested by small retrospective or prospective case series.
This is a randomized, multi center study comparing the outcomes of surgery alone and PRGF
plus surgery in patients requiring surgical treatment for MRONJ.
To assess the superiority of surgery plus PRGF compared to surgery alone in patients treated
for MRONJ. Primary endpoint for this scope is a composite of clinical or radiological
recurrence rate of disease during a 12 months post-operative period.
Secondary endpoints are: a) morbidity, defined as nerve injury, bleeding, vascular or wound
complications. b) post- and peri-operative pain defined by the treated subjects according to
a standardized VAS score c) quality of life (QoL) defined by a standardized scale.
n/a
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