MRONJ and Polynucleotides-Hyaluronic Acid Hydrogel (Regenfast®)

N/ANot Yet RecruitingNCT06984107

Fondazione Policlinico Universitario Agostino Gemelli IRCCS10 enrolled

Overview

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®)

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Interventions

MRONJ resection plus PN+HADEVICE

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.

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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