NCT06984107

MRONJ and Polynucleotides-Hyaluronic Acid Hydrogel (Regenfast®)

Intra-operative Application of Polynucleotides-Hyaluronic Acid Hydrogel (Regenfast®) for the Surgical Treatment of Medication-related Osteonecrosis of the Jaws (MRONJ): a Pilot Study

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

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®)

Conditions

• Medication Related Osteonecrosis of the Jaw

Interventions

Type	Name	Description
DEVICE	MRONJ resection plus PN+HA	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.

Timeline

• Start date: 2025-09-01
• Primary completion: 2026-09-01
• Completion: 2027-03-01
• First posted: 2025-05-22
• Last updated: 2025-05-29