Clinical trial NCT03390777: Plasma Rich in Growth Factors for Treatment of Medication Related Osteonecrosis of the Jaw
Official title: Plasma Rich in Growth Factors for Treatment of Medication Related Osteonecrosis of the Jaw: a Multicenter, Randomized, Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Osteonecrosis Due to Drugs, Jaw
Lead sponsor: University of Roma La Sapienza
Sponsor class: OTHER
Collaborators: name: NYU College of Dentistry
name: Universidade da Coruña
First posted: 2018-01-04
Enrollment: 150
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: recurrence of disease
timeFrame: 12 months
Secondary outcomes:
measure: morbidity
timeFrame: 12 months
measure: post- and peri-operative pain
timeFrame: 1 week
measure: quality of life (QoL)
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
References:
citation: Beth-Tasdogan NH, Mayer B, Hussein H, Zolk O, Peter JU. Interventions for managing medication-related osteonecrosis of the jaw. Cochrane Database Syst Rev. 2022 Jul 12;7(7):CD012432. doi: 10.1002/14651858.CD012432.pub3.