MRONJ and Polynucleotides-Hyaluronic Acid Hydrogel (Regenfast®)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: MRONJ resection plus PN+HA.
- Who it may be relevant to
- Registry conditions: Medication Related Osteonecrosis of the Jaw. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Intra-operative Application of Polynucleotides-Hyaluronic Acid Hydrogel (Regenfast®) for the Surgical Treatment of Medication-related Osteonecrosis of the Jaws (MRONJ): a Pilot Study
Overview
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®)
Interventions
- 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.
Primary outcome measures
- Clinical wound healing (modified Landry Healing Index) [Time frame: 7 days after surgical treatment]
- Clinical wound healing (modified Landry Healing Index) [Time frame: 14 days after surgical treatment]
- Clinical wound healing (modified Landry Healing Index) [Time frame: 21 days after surgical treatment]
- Clinical wound healing (modified Landry Healing Index) [Time frame: 3 months after surgical treatment]
- Clinical wound healing (modified Landry Healing Index) [Time frame: 6 months after surgical treatment]
- Clinical wound healing (modified Landry Healing Index) [Time frame: 12 months after surgical treatment]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06984107 · 7475