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MRONJ and Polynucleotides-Hyaluronic Acid Hydrogel (Regenfast®)

NCT06984107 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2025-05-29

No results posted yet for this study

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®)

Conditions

  • Medication Related Osteonecrosis of the Jaw

Interventions

DEVICE

MRONJ 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.

Sponsors & Collaborators

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    lead OTHER

Principal Investigators

  • Carlo Lajolo · Fondazione Policlinico Universitario A. Gemelli, IRCCS

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-01
Primary Completion
2026-09-01
Completion
2027-03-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06984107 on ClinicalTrials.gov