Osteonecrosis Due to Drugs, Jaw
Conditions
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.
Interventions
PROCEDUREsurgery
surgery without the use of prgf
DEVICEPRGF after surgery
surgery and application of PRGF
Sponsors
NYU College of Dentistry
Universidade da Coruña
University of Roma La Sapienza
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| recurrence of disease | 12 months | clinical or radiological recurrence rate of disease during a 12 months post-operative period |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| morbidity | 12 months | nerve injury, bleeding, vascular or wound complications |
| 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. |
| 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/ |
Contacts
Primary ContactOreste Iocca, D.D.S., M.D.
Outcome results
None listed