An interventional study of MRONJ resection plus PN+HA in Medication Related Osteonecrosis of the Jaw, sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. Not yet recruiting. Per ClinicalTrials.gov, last updated 2025-05-29.
Sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Not applicable, Interventional, and Treatment
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®)
286 studies on the registry are indexed under Osteonecrosis; 45 are open to participants now.
This study's planned enrollment of 10 is below the median of 68 across 151 interventional studies indexed under Osteonecrosis.
Browse Osteonecrosis studies →Fondazione Policlinico Universitario Agostino Gemelli IRCCS is the lead sponsor of 952 studies on the registry; 541 are open to participants now.
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Exclusion criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
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Contraindication
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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
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.
Clinical wound healing (modified Landry Healing Index)
The clinical wound healing of the site will be assessed throughout the modified Landry Healing Index
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 12 months after surgical treatment
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This study is not yet recruiting, as verified in May 2025. You cannot join it, but the record below documents what was studied.
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Fondazione Policlinico Universitario Agostino Gemelli IRCCS →