Abstract
Purpose
Medication-related osteonecrosis of the jaws has been reported to be associated with bisphosphonate and RANKL inhibitor medications. This prospective clinical study aimed to assess the outcomes of pre-operative ozone infiltration therapy in patients with established MRONJ.
Methods
The treatment protocol for ozone applications were designed as 20 applications ozone infiltration therapy followed by surgical interventions of necrotic tissue debridement using piezoelectric surgery instruments. The evaluation of the results based on the clinical and radiologic specifications considering the necrotic lesion reduction and healing. The study included 31 lesions in 29 patients. The mean follow-up was 23.6 months.
Results
25 lesions out of 31 healed totally without any remissions. The outcomes were not affected by any variables such as gender, age, type of pharmacological treatment, lesion location, and MRONJ staging. The statistically significant results were found among the clinical condition of the patients (p = 0.01) and administration route of medications (p = 0.004). Healing was significantly less in patients that received intra-vascular administrations. Clinical conditions of the patients were divided as osteoporosis, oncologic, and arthritis. Significantly better results were obtained in osteoporosis patients. 38% of the population experienced spontaneous sequestration with signs of improvements and the surgical interventions were canceled. According to the results, total healing of MRONJ lesions was seen in 79% patients (81% lesions).
Conclusion
Ozone therapy and debridement with Piezoelectric surgery can be considered as a safe and beneficial adjunctive treatment alternative for osteonecrosis lesions in cases of established MRONJ.
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F.G., D.G., Fr.Ga., and M.D.F. conceived and designed the analysis. Databases were searched and data was collected by F.G., D.G., Fr.Ga., and M.D.F. Ozone/oxygen applications and surgical interventions were performed by D.G. All the authors contributed on analysis and interpretation of data for the work. F.G. drafted the work and wrote the manuscript with input from all authors. F.G., D.G., Fr.Ga., S.A., V.R., B.A., Fr. Gr., E.G., G.C., and M.D.F. revised the work critically for intellectual content. Integrity of the work was appropriately investigated and resolved by all authors. All authors contributed and approved equally to the final version of the manuscript.
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The study protocol was approved by the Ethics Committee of Milano Area A on date 12/02/2015 by number 0004902. The ethics approval in 2015 included just Stage 1 and Stage 2 patients. In March 2019 additional permission was taken from the same ethical Committee of Milano Area A for inclusion of Stage 3 patients in the study (Protocol numbers 10115/2019 and 13689/2019). This work followed the principles laid down in the Declaration of Helsinki on medical protocol.
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Goker, F., Donati, G., Gallo, F. et al. Ozone infiltration as an adjunctive treatment to piezoelectric surgery in the management of medication-related osteonecrosis of the jaws: case series of 29 patients. Oral Maxillofac Surg (2024). https://doi.org/10.1007/s10006-024-01246-x
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DOI: https://doi.org/10.1007/s10006-024-01246-x