Infiltration of Medical Ozone for the Treatment of Medication-Related Osteonecrosis of the Jaws (MRONJ)
Status:
Suspended
Trial end date:
2022-03-01
Target enrollment:
Participant gender:
Summary
Medication-related osteonecrosis of the jaw (MRONJ) is a serious adverse reaction of
antiresorptive and antiangiogenic agents; it is also a potentially painful and debilitating
condition. Today, no specific studies have prospectively evaluated the efficacy of its
treatment and no robust standard of care has been established.
Among non-invasive procedures to treat MRONJ, the use of medical ozone (O3) arises for its
properties and has been deployed and evaluated. O3 has generally proven to play a role in the
treatment of chronic, nonhealing, or ischemic wounds, due to its antimicrobial and
anti-oxidant properties and to bio-stimulation; it has been extensively used for different
medical approaches and purposes. In oral cavity, local applications are carried out by
ozonized water (i.e. spray or compress) or gel.
The aim of this open trial is to assess the efficacy and the safety of O3 by a new method of
application, i.e. infiltrations of oral mucosa, in patients with a diagnosis of MRONJ, which
are non-eligible for the standard of care, regardless staging.
All cases included in our study are MRONJ and staged according to the classification of the
Italian Societies of Oral Medicine and Maxillofacial Surgery (the SICMF/SIPMO staging
system); in addition, they arereported to AIFA, the Italian Medicines Agency, for
registration of the adverse event drug related.Patients included in our study are selected
due to their non-eligibility to the standard treatment (conservative/medical for long term or
surgical alone) for unstable systemic conditions or unaccepted consent due to extensive
proposed approach due to the advanced disease.
During the first examination (T0), medical, pharmacological, and dental history of patients
are recorded. Data collected are: (1) age; (2) gender; (3) indications for use, type,
cumulative dose and duration of MRONJ-related drugs; (4); history of chemotherapy; (5) other
medications; (6) other diseases; (7) smoking.
For every patient, Cone Beam CT dental scan or maxillofacial CT scan has performed for
staging at T0 and 12 (T4) months after; orthopantomograph has performed during protocol (T3).
The main CT features evaluated and associated to MRONJ presence and healing are as follows:
a) bone sclerosis, b) depth of lesion; c) formation of sequestrum.
When more than one MRONJ lesion are present, the protocol is applied one by one.