MRONJ and Polynucleotides-Hyaluronic Acid Hydrogel (Regenfast®) (REG-MRONJ-1)

Institute of Hospitalization and Scientific Care (IRCCS)

Status: Not yet enrolling

Conditions: Medication Related Osteonecrosis of the Jaw

Treatments: Device: MRONJ resection plus PN+HA

Study type: Interventional

Funder types: Other

Identifiers

NCT06984107

7475

Details and patient eligibility

About

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®)

Enrollment: 10 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients older than 18 years
• Provided informed consent
• MRONJ stage 1 and stage 2 diagnosis, in accordance to SICMF-SIPMO classification
• Need to undergo surgical treatment of MRONJ

Exclusion criteria

• Patients with history of head and neck radiotherapy
• Neurological and psychiatric conditions
• Pregnancy
• MRONJ stage 3 diagnosis
• Patients who will receive a re-treatment for MRONJ
• Patients with general contraindication for oral surgery
• Patients unable to attend the out-patients visits scheduled by the protocol

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Surgical resection plus polynucleotides and hyaluronic acid (PN+HA)

Experimental group

Description:

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.

Treatment:

Device: MRONJ resection plus PN+HA