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
Qualifiers
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
Treatments tested in this trial
- MRONJ resection plus PN+HA
Treatment groups
10 Participants
are divided into 1 treatment groupLocations
Sponsors and collaborators
Source ClinicalTrials.gov