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Several circumstances or conditions, such as wound extension or disease, can affect the hard and soft tissue healing after surgical treatment of MRONJ. Supportive therapies are therefore needed to help tissues wound healing. The primary objective of this pilot clinical case series is to evaluate the post-operative wound healing in a group of patients undergoing surgical therapy for MRONJ with intraoperative application of a gel based on polynucleotides and hyaluronic acid (PN+HA) (Regenfast®)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Surgical resection plus polynucleotides and hyaluronic acid (PN+HA) | Experimental | Surgical management will be performed by reflecting a full-thick flap to expose the entire affected area, followed by removal of necrotic bone until a vital, unaffected bony margin will be obtained. After bone resection, the PN+HA (Regenfast®) will be applied on the residual bone surface. Wound management will be done via primary closure. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MRONJ resection plus PN+HA | Device | Surgical management will be performed by reflecting a full-thick flap to expose the entire affected area, followed by removal of necrotic bone until a vital, unaffected bony margin will be obtained. After bone resection, the PN+HA (Regenfast®) will be applied on the residual bone surface. Wound management will be done via primary closure. |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical wound healing (modified Landry Healing Index) | The clinical wound healing of the site will be assessed throughout the modified Landry Healing Index | 7 days after surgical treatment |
| Clinical wound healing (modified Landry Healing Index) | The clinical wound healing of the site will be assessed throughout the modified Landry Healing Index | 14 days after surgical treatment |
| Clinical wound healing (modified Landry Healing Index) | The clinical wound healing of the site will be assessed throughout the modified Landry Healing Index | 21 days after surgical treatment |
| Clinical wound healing (modified Landry Healing Index) | The clinical wound healing of the site will be assessed throughout the modified Landry Healing Index | 3 months after surgical treatment |
| Clinical wound healing (modified Landry Healing Index) | The clinical wound healing of the site will be assessed throughout the modified Landry Healing Index | 6 months after surgical treatment |
| Clinical wound healing (modified Landry Healing Index) | The clinical wound healing of the site will be assessed throughout the modified Landry Healing Index | 12 months after surgical treatment |
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Inclusion criteria:
Exclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Carlo Lajolo | Contact | +393401004585 | carlo.lajolo@policlinicogemelli.it |
| Name | Affiliation | Role |
|---|---|---|
| Carlo Lajolo | Fondazione Policlinico Universitario Agostino Gemelli IRCCS | Principal Investigator |
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