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Clinical Trial 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.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT03390777
Study type Interventional
Source University of Roma La Sapienza
Contact Oreste Iocca, D.D.S., M.D.
Phone 0039 3398540122
Email oi243@nyu.edu
Status Not yet recruiting
Phase Phase 2/Phase 3
Start date September 2018
Completion date January 2022

See also
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Completed NCT03269214 - Use of Topical Phenytoin in Bisphosphonate-related Osteonecrosis of the Mandible N/A
Terminated NCT04257721 - Predictive Score For Maxillary Osteonecrosis After Invasive Oral Surgery
Completed NCT04540601 - Antiresorptive Drug Continuation Compared With Drug Holiday in Cancer Patients Needing Tooth Extraction N/A
Recruiting NCT06457776 - Medication Related Osteonecrosis of the Jaws (MRONJ) in a Cohort of Patients Treated by Antiresorptive Drugs
Completed NCT04717765 - Photobiomodulation in Oral Lesions Resulting From Anti-neoplastic Prevention N/A