Oral Surgery, Oral Medicine, Oral Pathology, Oral Radiology, and Endodontology
Oral and maxillofacial pathologyA prospective clinical trial for assessing the efficacy of a minimally invasive protocol in patients with bisphosphonate-associated osteonecrosis of the jaws
Section snippets
Materials and Methods
This prospective study enrolled 34 consecutive patients with ONJ (14 male, 20 female, mean age 69.0 ± 7.1 years, range 48-85 years) who presented to the Department of Oral Science of the University of Bologna School of Dentistry during the past 3.5 years. Twenty-seven patients had been treated with zoledronate, 3 with pamidronate, and 4 with alendronate. No patient had evidence of maxillary or mandibular metastasis or a history of radiation therapy. Twelve patients had multiple myeloma, 11 had
Results
The mean follow-up duration was 16.0 ± 9.4 months (range 3-40 months).
Table I presents the clinical findings for the entire patient population before and after the proposed minimally invasive protocol.
The 1-way ANOVA did not reveal any statistical difference in the initial extent of exposed bone between the mandible (13.2 ± 12.9 mm) and maxilla (10.4 ± 9.5), between men (12.7 ± 10.5 mm) and women (12.3 ± 13.2 mm), or regarding the type of bisphosphonate therapy (zoledronate, 13.3 ± 12.2 mm; pamidronate,
Discussion
Bisphosphonate-associated ONJ is a well documented side effect of the therapy15; nevertheless, there is no consensus on the best protocol for treating the areas of exposed bone.11, 12, 13, 14 Most of the relevant literature reports case studies or retrospective studies, which are heterogeneous and difficult to compare. Furthermore, given that intravenous bisphosphonates are life-saving drugs for oncology patients, ethical considerations prevent analyzing these agents in randomized trials.
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