Status:
NOT_YET_RECRUITING
MRONJ and Polynucleotides-Hyaluronic Acid Hydrogel (Regenfast®)
Lead Sponsor:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Conditions:
Medication Related Osteonecrosis of the Jaw
Eligibility:
All Genders
Phase:
NA
Brief Summary
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 hel...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
September 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2027
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT06984107
Start Date
September 1 2025
End Date
March 1 2027
Last Update
May 29 2025
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