MRONJ and Polynucleotides-Hyaluronic Acid Hydrogel (Regenfast®)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS
About this trial
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®)
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Patients with history of head and neck radiotherapy
Neurological and psychiatric conditions
Pregnancy
MRONJ stage 3 diagnosis
Trial design
Design model
Single group
Treatments tested in this trial
MRONJ resection plus PN+HA
DeviceSurgical 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.
Treatment groups
10 Participants
are divided into 1 treatment groupGroup A: Surgical resection plus polynucleotides and hyaluronic acid (PN+HA)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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 treatment2
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 treatment3
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 treatment4
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 treatmentLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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