OZONE_EXO: Comparative Analysis of Protocols for Dental Exactions in Patients at Risk of MRONJ: Case-control Study

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 study was to carry out a case-control study in order to compare two different protocols of dental extractions in patients at risk of MRONJ, with and without infiltration of a mixture of oxygen-ozone. All the cases in our study are cancer and oncologic and osteometabolic patients undergoing high-risk therapy for MRONJ (antiresorptive and antiangiogenic drugs) who require dental extractions with a poor prognosis. 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 each patient, an orthopantomography and a cone beam computed tomography of the teeth are performed only if indicated.

Timeline

Start

2018-02-01

Primary completion

2020-03-30

Completion

2020-03-30

Publications

• Background Campisi G, Mauceri R, Bertoldo F, Bettini G, Biasotto M, Colella G, Consolo U, Di Fede O, Favia G, Fusco V, Gabriele M, Lo Casto A, Lo Muzio L, Marciano A, Mascitti M, Meleti M, Mignogna MD, Oteri G, Panzarella V, Romeo U, Santarelli A, Vescovi P, Marchetti C, Bedogni A. Medication-Related Osteonecrosis of Jaws (MRONJ) Prevention and Diagnosis: Italian Consensus Update 2020. Int J Environ Res Public Health. 2020 Aug 18;17(16):5998. doi: 10.3390/ijerph17165998.
• Background Oldoini G, Frabattista GR, Saragoni M, Cosola S, Giammarinaro E, Genovesi AM, Marconcini S. Ozone Therapy for Oral Palatal Ulcer in a Leukaemic Patient. Eur J Case Rep Intern Med. 2020 Jan 14;7(2):001406. doi: 10.12890/2020_001406. eCollection 2020.
• Background Palma LF, Joia C, Chambrone L. Effects of ozone therapy on periodontal and peri-implant surgical wound healing: a systematic review. Quintessence Int. 2023 Feb 10;54(2):100-110. doi: 10.3290/j.qi.b3512007.
• Background Agrillo A, Ungari C, Filiaci F, Priore P, Iannetti G. Ozone therapy in the treatment of avascular bisphosphonate-related jaw osteonecrosis. J Craniofac Surg. 2007 Sep;18(5):1071-5. doi: 10.1097/scs.0b013e31857261f.

Drugs

Indications