Amoxicillin-Metronidazole vs Spiramycin-Metronidazole in the Treatment of Odontogenic Circumscribed Cellulitis: Randomized Clinical Trial in Odontostomatology
Introduction : In clinical practice, amoxicillin-metronidazole is widely used in the treatment of odontogenic infections. Therefore, this study was designed to generate data to support its use. This demonstrated the clinical efficacy of the amoxicillin-metronidazole combination compared with the spiramycin-metronidazole combination in subjects with odontogenic circumscribed cellulitis. The clinical trial was supplemented by an evaluation of the compliance and tolerability of the antibiotics under study. Methodology : This was a randomized, parallel, comparative, double-blind clinical trial. This study evaluated the efficacy, tolerability, and compliance of amoxicillin-metronidazole and spiramycin-metronidazole combinations in adult subjects with odontogenic circumscribed cellulitis. Subjects were reassessed after three, five and seven days. At the end of the treatment, the patients were classified in (clinical success) or “failure”. Results : The study was conducted on 81 patients in intention-to-treat analysis and 61 patients in per-protocol analysis. In intent to treat, the clinical success of amoxicillin-metronidazole, spiramycin-metronidazole combinations was greater than 90% in the treatment of serous circumscribed cellulitis. Clinical tolerance and compliance were not different from one group to another. Conclusion : The non-inferiority of amoxicillin-metronidazole comination compared to spiramycin-metronidazole combination was demonstrated in intention-to-treat and per- protocol analysis.