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

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Objective

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).

Study design

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.

Results

The results from the general linear model showed a statistically significant (F = 16.1; P < .01; r2 = 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).

Conclusions

This conservative protocol seems to provide successful treatment in the vast majority of patients.

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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