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Search / Trial NCT06984107

MRONJ and Polynucleotides-Hyaluronic Acid Hydrogel (Regenfast®)

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

Trial Information

Current as of July 09, 2025

Not yet recruiting

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

About Fondazione Policlinico Universitario Agostino Gemelli Irccs

Fondazione Policlinico Universitario Agostino Gemelli IRCCS is a leading research and healthcare institution based in Rome, Italy, renowned for its commitment to advancing medical science and improving patient care. As a prominent academic medical center affiliated with the Catholic University of the Sacred Heart, it integrates clinical practice, education, and research, fostering innovation in various fields of medicine. The foundation conducts a wide range of clinical trials aimed at developing new therapies and enhancing treatment protocols, with a focus on translational research that bridges the gap between laboratory discoveries and patient care. Its multidisciplinary approach and dedication to high ethical standards position it as a key player in the landscape of clinical research and healthcare improvement in Italy and beyond.

Locations

Patients applied

0 patients applied

Trial Officials

Carlo Lajolo

Principal Investigator

Fondazione Policlinico Universitario A. Gemelli, IRCCS

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported