NCT06984107

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®)

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
10mo left

Started Sep 2025

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress46%
Sep 2025Mar 2027

First Submitted

Initial submission to the registry

May 14, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 22, 2025

Completed
3 months until next milestone

Study Start

First participant enrolled

September 1, 2025

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2027

Last Updated

May 29, 2025

Status Verified

May 1, 2025

Enrollment Period

1 year

First QC Date

May 14, 2025

Last Update Submit

May 22, 2025

Conditions

Medication Related Osteonecrosis of the Jaw

Outcome Measures

Primary Outcomes (6)

  • Clinical wound healing (modified Landry Healing Index)

    The clinical wound healing of the site will be assessed throughout the modified Landry Healing Index

    7 days after surgical treatment

  • Clinical wound healing (modified Landry Healing Index)

    The clinical wound healing of the site will be assessed throughout the modified Landry Healing Index

    14 days after surgical treatment

  • Clinical wound healing (modified Landry Healing Index)

    The clinical wound healing of the site will be assessed throughout the modified Landry Healing Index

    21 days after surgical treatment

  • Clinical wound healing (modified Landry Healing Index)

    The clinical wound healing of the site will be assessed throughout the modified Landry Healing Index

    3 months after surgical treatment

  • Clinical wound healing (modified Landry Healing Index)

    The clinical wound healing of the site will be assessed throughout the modified Landry Healing Index

    6 months after surgical treatment

  • Clinical wound healing (modified Landry Healing Index)

    The clinical wound healing of the site will be assessed throughout the modified Landry Healing Index

    12 months after surgical treatment

Study Arms (1)

Surgical resection plus polynucleotides and hyaluronic acid (PN+HA)

EXPERIMENTAL

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.

Device: MRONJ resection plus PN+HA

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.

Surgical resection plus polynucleotides and hyaluronic acid (PN+HA)

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Carlo Lajolo

    Fondazione Policlinico Universitario A. Gemelli, IRCCS

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Carlo Lajolo

CONTACT

+393401004585carlo.lajolo@policlinicogemelli.it

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 14, 2025

First Posted

May 22, 2025

Study Start

September 1, 2025

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

March 1, 2027

Last Updated

May 29, 2025

Record last verified: 2025-05