NCT Number: NCT06984107
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 opening soon.
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Interventional
Not applicable
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 7 days after surgical treatment
The clinical wound healing of the site will be assessed throughout the modified Landry Healing Index
Time frame: 14 days after surgical treatment
The clinical wound healing of the site will be assessed throughout the modified Landry Healing Index
Time frame: 21 days after surgical treatment
The clinical wound healing of the site will be assessed throughout the modified Landry Healing Index
Time frame: 3 months after surgical treatment
The clinical wound healing of the site will be assessed throughout the modified Landry Healing Index
Time frame: 6 months after surgical treatment
The clinical wound healing of the site will be assessed throughout the modified Landry Healing Index
Time frame: 12 months after surgical treatment
The clinical wound healing of the site will be assessed throughout the modified Landry Healing Index
Contact information is provided by the study sponsor or research team.
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Other
Intra-operative Application of Polynucleotides-Hyaluronic Acid Hydrogel (Regenfast®) for the Surgical Treatment of Medication-related Osteonecrosis of the Jaws (MRONJ): a Pilot Study
Acronym: REG-MRONJ-1
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