MRONJ and Polynucleotides-Hyaluronic Acid Hydrogel (Regenfast®)

Launched by FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS · May 20, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment to help patients heal after surgery for a condition called Medication Related Osteonecrosis of the Jaw (MRONJ). MRONJ can occur in patients who have taken certain medications, leading to problems with the jawbone. The trial will look at how well a special gel, made from natural substances called polynucleotides and hyaluronic acid, helps wounds heal after surgery. The goal is to find out if this gel can improve healing in patients who have surgery for stages 1 and 2 of MRONJ.

To participate in this trial, you need to be over 18 years old and have been diagnosed with MRONJ stage 1 or 2. You must also be able to provide consent and attend follow-up visits after your surgery. Unfortunately, people who have had radiation therapy to the head and neck, are pregnant, or have serious health issues that could complicate surgery will not be eligible. If you join this study, you can expect to receive the gel during your surgery and to be monitored afterward to see how well you heal. This trial is currently not recruiting participants, but it aims to gather important information about improving recovery for those undergoing treatment for MRONJ.

Gender

ALL

Eligibility criteria

• 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