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| Name | Class |
|---|---|
| NYU College of Dentistry | OTHER |
| Universidade da Coruña | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| surgery only | Active Comparator | Surgery consisting in debridement/removal of affected tissue/s will be performed. |
|
| surgery and PRGF | Active Comparator | 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| surgery | Procedure | surgery without the use of prgf |
| |
| PRGF after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| recurrence of disease | clinical or radiological recurrence rate of disease during a 12 months post-operative period | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| morbidity | nerve injury, bleeding, vascular or wound complications | 12 months |
| post- and peri-operative pain | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Oreste Iocca, D.D.S., M.D. | Contact | 0039 3398540122 | oi243@nyu.edu |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35866376 | Derived | 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. |
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IPD will be shared and evaluated upon requests
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| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
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| Device |
surgery and application of PRGF |
|
| 1 week |
| quality of life (QoL) | 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/ | 12 months |