A prospective clinical trial for assessing the efficacy of a minimally invasive protocol in patients with bisphosphonate-associated osteonecrosis of the jaws

Abstract

The objective of this study was to assess whether a minimally invasive protocol can be effective in the long-term control of necrotic areas and pain in patients suffering osteonecrosis of the jaw associated with the use of bisphosphonate drugs (BRONJ). Thirty-four consecutive patients (14 male, 20 female) with BRONJ under treatment with zoledronate, pamidronate, or alendronate were enrolled. All of the patients received professional oral hygiene treatment and antiseptic oral rinses, and if in pain they assumed an antibiotic therapy with amoxicillin/clavulanate potassium and metronidazole for ten days. At the baseline visit, as well as at each 3-month recall, the size of the osteonecrotic lesions were measured and the pain level assessed with a visual analog scale. The results from the general linear model showed a statistically significant (F = 16.1; P < .01; r(2) = 0.95) time-related decrease in the size of exposed bone areas during the nonsurgical therapy (from 12.5 ± 12.0 mm to 8.8 ± 10.3 mm). This conservative protocol seems to provide successful treatment in the vast majority of patients.