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

Phase 2

• Conditions: Osteonecrosis Due to Drugs, Jaw
• Interventions: Procedure: surgery; Device: PRGF after surgery

• Registration Number: NCT03390777
• Lead Sponsor: University of Roma La Sapienza

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-12-26
• Status Verified: 2018-01
• Study First Submitted QC: 2018-01-03
• Study First Posted: 2018-01-04
• Last Update Submitted: 2018-01-04
• Last Update Posted: 2018-01-08
• Study Start: 2018-09
• Primary Completion: 2021-09
• Study Completion: 2022-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
surgery only	surgery	Surgery consisting in debridement/removal of affected tissue/s will be performed.
surgery and PRGF	PRGF after surgery	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

Primary Outcome Measures

Name	Time	Method
recurrence of disease	12 months	clinical or radiological recurrence rate of disease during a 12 months post-operative period

Secondary Outcome Measures

Name	Time	Method
post- and peri-operative pain	1 week	defined by the treated subjects according to a standardized Visual Analog Scale (VAS) score which will be used to define the pain in this way: the patient will assign a value to the experienced pain that goes from 0 no pain to 10 the worst pain the patient can imagine.
morbidity	12 months	nerve injury, bleeding, vascular or wound complications
quality of life (QoL)	12 months	defined by a standardized scale developed by the who and whose details can be on the who website http://www.who.int/mental_health/publications/whoqol/en/