Plasma Rich in Growth Factors for Treatment of Medication Related Osteonecrosis of the Jaw

University of Roma La Sapienza

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Osteonecrosis Due to Drugs, Jaw

Treatments: Procedure: surgery; Device: PRGF after surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT03390777

26122017

Details and patient eligibility

About

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.

Enrollment: 150 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects must be candidates for surgical treatment for MRONJ at stage 2 or 3.
• Subjects must be >18 and <80 years of age
• Subjects must sign a informed consent prior to randomization and must agree to return to scheduled follow-up visits

Exclusion criteria

• Subject has inability to understand and cooperate with the study procedures or provide informed consent
• Subject has bleeding diathesis or coaugolapthy, or will refuse autologous blood sampling
• Subject had a cardiovascular event in the past 30 days
• Subject has any condition that limits their anticipated survival to less than 3 months

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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150 participants in 2 patient groups

surgery only

Active Comparator group

Description:

Surgery consisting in debridement/removal of affected tissue/s will be performed.

Treatment:

Procedure: surgery

surgery and PRGF

Active Comparator group

Description:

Surgery consisting in debridement/removal of affected tissue/s will be performed. Platelet Rich Growth Factor (device) will be produced by a venous blood sampling of the patient and applied to the treated area

Treatment:

Device: PRGF after surgery