Efficacy and safety of medical ozone (O3) delivered in oil suspension applications for the treatment of osteonecrosis of the jaw in patients with bone metastases treated with bisphosphonates: Preliminary results of a phase I–II study

Autor: Luigi Mariani, Enrico Cislaghi, Carla Ripamonti, M. Maniezzo
Rok vydání: 2011
Předmět:
Zdroj: Oral Oncology. 47:185-190
ISSN: 1368-8375
Popis: summary Osteonecrosis of the jaw (ONJ) is an adverse event that has been reported in patients receiving cancer treatment regimens, including bevacizumab, bisphosphonates, and denosumab. We performed a preliminary open label, prospective phase I–II study in patients treated with bisphosphonate to evaluate the treatment effect and tolerability of medical ozone (O3) delivered in an oil suspension on BONJ lesions 62.5 cm. Ten consecutive patients with BONJ lesions not responsive to conservative treatment were pretreated with 10 days of antibiotics to reduce purulent secretions on the gum. The exposed bone lesion and osteomucosal edge was cleaned with an ultrasonic scaler. The BONJ lesion was treated with 10 local applications of medical O3 delivered in an oil suspension for 10 min. In all patients, mucosal lesions resolved with complete reconstitution of oral and jaw tissue, with 3–10 applications. No toxicity was reported. Unexpectedly, total sequestration of the necrotic bone, with spontaneous expulsion in eight patients and new bone formation around the necrotic area in two patients was observed. No patient required surgical intervention. In two patients with pre-and post-treatment X-rays, no residual bone lesions were observed after treatment. These preliminary results show the efficacy and tolerability of O3 delivered in an oil suspension applied directly to BONJ lesions 62.5 cm, thus indicating that BONJ can be a manageable and potentially curable condition.
Databáze: OpenAIRE