Effectiveness of Oral Cephalexin-Clavulanic Acid, Cefuroxime, and Amoxicillin-Clavulanic Acid in the Management of Dental Infections: A Real-World, Retrospective, Electronic Medical Record-Based Study in India

Abstract

Abstract Background Despite multiple antibiotics being available to manage dental infections (DI), there is lack of data comparing commonly prescribed antibiotics in India. Objectives The aim of this study was to evaluate the real-world effectiveness and tolerability of cephalexin-clavulanic acid fixed-dose combination (cephalexin CV FDC) in contrast with amoxicillin-clavulanic acid (co-amoxiclav FDC) and cefuroxime among patients with dental infections (odontogenic) in India. Methods This retrospective, multi-centric, observational, real-world electronic medical record (EMR)-based study was conducted between January 2022 and December 2022. The EMRs of 355 adults with DI receiving oral cephalexin CV, co-amoxiclav, or cefuroxime were categorized into two distinct groups: Group I (Test Group) with patients prescribed cephalexin extended release 375/750 mg along with clavulanic acid 125 mg; and Group II (Comparator Group) with patients prescribed co-amoxiclav 625 mg (500 mg amoxicillin + 125 mg clavulanic acid) or cefuroxime (250 mg/500 mg). Results Toothache was the most common complaint, reported by 95.5% of patients, followed by swelling (46.8%), tooth sensitivity (35.5%), pus discharge (33.0%), redness and halitosis (30.4% each). Dental caries was observed in 81.1% of patients. Clinical improvement, defined as improvement/partial resolution of infection-related clinical signs and symptoms (composite measure of pain, swelling, fever, requirement of additional antimicrobial therapy) as per dentists’ judgment, was recorded in 98.3% of patients with cephalexin CV, 96.8% of patients with co-amoxiclav, and 98.9% of patients treated with cefuroxime within 10 days. Time (days) to clinical improvement was numerically lesser among patients receiving cephalexin CV (4.6 ± 2.0) compared with cefuroxime (4.9 ± 2.1) and co-amoxiclav (5.0 ± 2.6). All treatments were well tolerated. Conclusion Cephalexin CV was as effective as co-amoxiclav and cefuroxime, with faster clinical improvement and better resolution of certain symptoms.