Eur Rev Med Pharmacol Sci 2020; 24 (17): 9094-9103
F. Goker, G. Donati, F. Grecchi, A. Sparaco, M. Ghezzi, V. Rania, C.A. Rossi, M. Del Fabbro
Department of Biomedical, Surgical and Dental Sciences, University of Milano, Milan, Italy.
OBJECTIVE: Bisphosphonate related osteonecrosis of the jaw (BRONJ) is progressive bone destruction in the maxillofacial region of patients under current or previous treatment with Bisphosphonates. The present case series study aimed to evaluate if ozone/oxygen therapy and debridement with piezoelectric surgery may improve the treatment of BRONJ.
PATIENTS AND METHODS: The treatment modality of the patients included ozone/oxygen mixture from medical oxygen. The protocol for ozone/oxygen mixture therapy appointments was set as twice a week for 10 weeks, for a total of 20 applications for each patient. The evaluation of the lesions was based on the clinical and radiologic parameters. The primary outcome was the necrotic lesion reduction during ozone/oxygen therapy sessions and up to the end of follow up periods. The healing of the lesion was taken as a positive result. The level of significance was taken as p <0.05.
The study population of this study included 14 patients, which referred to the Clinic of Dental Medicine at Luigi Sacco Hospital (Milan, Italy), between 14/06/2015 and 14/06/2019. The study protocol was approved by the Ethics Committee of Milano Area A on date 12/02/2015 by no 0004902 .The study was in compliance with the principles laid down in the Declaration of Helsinki on medical protocol. A signed an informed consent agreement form was obtained from all the patients. In the present study American Association for Oral and Maxillofacial Surgeons classification 2014 was used to indicate the stage of MRONJ for the patients 11. Inclusion criteria were set as 1st and 2nd stage patients with bisphosphonate-related osteonecrosis of the jaws and necrotic lesion equal or smaller than 5 mm.
Exclusion criteria were patients with no BRONJ and BRONJ 3rd stage patients.
The treatment modality of the patients included ozone/oxygen mixture from a medical device. The protocol for ozone/oxygen mixture therapy appointments was set as twice a week for 10 weeks, for a total of 20 applications for each patient. The evaluation of the lesions was based on the clinical and radiologic parameters. The primary objective
was necrotic lesion reduction during ozone/oxygen therapy and up to the end of follow-up periods.
Healing of the necrotic tissue was taken as a positive result. The presence of side effects and complications were additionally evaluated.
The ozone/oxygen mixture was applied with local submucosal infiltrations around the necrotic area and in fistulous tracts. Infiltrations were performed with a 10cc syringe, with 30 gauges needle, 0.30 × 13. The injections were 2/3 cc
for inoculation up to a maximum of 15 cc. The ozone/oxygen mixture was at a concentration of 10 micrograms/ml by using an individual ozone tray. The ozone/oxygen mixture was applied at a total concentration of 30 micrograms/ml for 2 minutes. The ozone tray, custom-built by the dental laboratory, included an entrance and exit hole. The entrance was directly connected to the ozone generator while the exit was connected to the unit’s aspirator. To ensure complete suction of the gas, a high-speed suction was placed at the bottom of the oral cavity.
After 10 applications, at the end of the 5th week (after the T2 time), the patients underwent surgical debridement of the necrotic tissue which might compromise wound healing under local anesthesia using sterile surgical instruments such as scissors, forceps, scalpel and piezoelectric scalpel.
All the patients were evaluated for any changes or complications and any adverse was added to the flow chart for each patient.
RESULTS: A total of 14 patients affected by osteonecrosis were included. The mean follow-up of the patients was 14.3 months. The overall success rate after treatment was 64.2%.
CONCLUSIONS: According to the results, ozone/oxygen therapy and debridement with Piezoelectric surgery for BRONJ treatment is a safe procedure with successful outcomes.