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

NCT06984107•Fondazione Policlinico Universitario Agostino Gemelli IRCCS

View on ClinicalTrials.gov

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®)

Eligibility

Age

All ages

Sex

ALL

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

Key Dates

Start Date

September 1, 2025

Primary Completion Date

September 1, 2026

Completion Date

March 1, 2027

Last Updated

May 29, 2025

Enrollment

ESTIMATED participants

Conditions

Medication Related Osteonecrosis of the Jaw

Interventions

MRONJ resection plus PN+HA

DEVICE

Contacts

Carlo Lajolo

CONTACT

+393401004585 carlo.lajolo@policlinicogemelli.it

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 29, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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