Treatment of bisphosphonate-related osteonecrosis of the jaws: presentation of a protocol and an observational longitudinal study of an Italian series of cases.

The aim of this study was to evaluate the efficacy of a treatment protocol for bisphosphonate-related osteonecrosis of the jaws (BRONJs). We conducted a longitudinal observational non-controlled study in 94 patients with confirmed BRONJ. Treatment was in two phases: supportive (antimicrobial mouth rinses, antibiotics, and anti-inflammatory steroids) to minimise infection and pain before the formation of a bony sequestrum; and surgical plus pharmacological treatment (sequestrectomy with antibiotic prophylaxis) after the sequestrum had developed. We did a Kaplan-Meier analysis (survival curve) to evaluate the time from the initial assessment until the formation of the bony sequestrum (endpoint), and a log-rank (Mantel-Haenszel) test to compare the formation times of the sequestra in men and women. Ninety-one of the 94 patients developed sequestra and were operated on. Three patients were withdrawn from the study because of severe pain and were treated by debridement before the sequestra developed. The results showed that sequestra developed within 15 months in all 91 patients. The Kaplan-Meier analysis showed that the mean time to formation of a sequestrum was 8 months (range 5-11). The difference between the mean time for men (5 months, range 2-8) and women (9 months, range 6-12) was highly significant (p<0.0001). Within the limits of this study, we conclude that by waiting for the formation of bony sequestra while controlling infection and pain, it is possible to do a conservative resection, unless pain is severe or there is a risk of fracture. This non-aggressive approach permits the removal of all necrotic bone, avoids damage to adjacent healthy bone, and does not result in recurrences.