A randomized, double blind study of clarithromycin versus metronidazole-spiramycin in the treatment of acute dental infections.

Objectives - A comparative clinical evaluation was designed to investigate the clinical relevance of the usefulnes of metronidazole and spiramycin for the treatment of acute dental infections. Materials and methods - We carried out a prospective, randomized, double bl ind, multicenter study in adult patients with acute dental infections (acut e periapical abscesses, acute cellulitis, pericoronitis, acute necrotic pul p infection, alveolitis). The number of patients was determined in order to demonstrate equivalence between the two regimens. Patients were randomly a ssigned to clarithromycin (250 mg) b.i.d. or spiramycin (1.5 MIU) + metroni dazole (250 mg) b.i.d. for five days. Results - A total of 352 patients were enrolled in the study: 341 (96.9%) w ere assessable in the intent-to-treat analysis and 321 (91.2%) were assessa ble per protocol, The clinical success rate at the final visit (10-15 days after end of therapy) was similar in both groups: 92% (clarithromycin) and 95% (metronidazole-spiramycin). Side effects were rare and mild (4.6%) in t he clarithromycin group and 5.8% in the metronidazole-spiramycin group (P = not significant). (C) 1999 Elsevier; Paris.