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

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06984107

Acronym

REG-MRONJ-1

Enrollment

Registered

2025-05-22

Start date

2025-09-01

Completion date

2027-03-01

Last updated

2025-05-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Medication Related Osteonecrosis of the Jaw

Brief 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®)

Interventions

DEVICEMRONJ 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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

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

Design outcomes

Primary

Measure	Time frame	Description
Clinical wound healing (modified Landry Healing Index)	7 days after surgical treatment	The clinical wound healing of the site will be assessed throughout the modified Landry Healing Index

Contacts

Primary ContactCarlo Lajolo

carlo.lajolo@policlinicogemelli.it+393401004585

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026