Amoxicillin/Clavulanic Acid for the Treatment of Odontogenic Infections: Comparing Efficacy and Tolerability versus Clindamycin

International Journal of Dentistry:

Odontogenic infections are one of the most prevalent diseases worldwide and the principal reason for seeking dental care. Dental prescriptions account for nearly 7% to 11% of all common antibiotic prescriptions.

The commonest emergency odontogenic infections are periapical abscess (25%), pericoronitis (11%), and periodontal abscess (7%).

Therapeutic success in odontogenic infections is determined by the control of infection by surgical debridement and/or antimicrobial therapy which is indicated when there are clear signs of systemic involvement such as pyrexia or lymphadenopathy.

The polymicrobial nature of odontogenic infections necessitates the use of antibiotics active against both aerobic and anaerobic bacteria. The antibiotics most commonly prescribed for acute dental abscesses are amoxicillin, penicillin, metronidazole, and erythromycin with clindamycin as an alternative in individuals allergic to the beta-lactam antibiotics.

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Recently, published evidence suggests that penicillin and amoxicillin are being rendered increasingly less effective because of beta-lactamase producing bacteria.

Studies have revealed the presence of beta-lactamase producing species in 74–88% of patients with periodontitis. Addition of a beta-lactamase inhibitor such as clavulanic acid to amoxicillin confers resistance to beta-lactamases thereby extending the antibiotic spectrum to anaerobes such as Prevotella spp. and Bacteroides spp. anaerobes and to Staphylococcus spp.

Efficacy of amoxicillin/clavulanic acid in the treatment of acute periapical abscess has been established in several studies.

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Clindamycin is a broad-spectrum antibiotic with activity against aerobic, anaerobic bacteria including coverage against beta-lactamase producing pathogens. Clinical trials have demonstrated the efficacy of clindamycin in treating odontogenic infections. Use of clindamycin in dental infections is based on careful patient selection in view of reported cases of pseudomembranous colitis (a rare but serious consequence of clindamycin).

The aim of the current study was to assess the clinical efficacy and safety of amoxicillin/clavulanic acid 875/125 mg twice daily versus clindamycin 150 mg four times daily, for 5 or 7 days in dental infections.

Amoxicillin/clavulanic acid (875 mg/125 mg) was administered twice daily for 5–7 days and was found to be noninferior or “comparable” to clindamycin (150 mg) administered four times daily.

Amoxicillin/clavulanic acid was comparable to clindamycin in achieving clinical success (88.2% versus 89.7%) in acute odontogenic infections and the safety profile was consistent with the known side effects of both drugs.

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Abstract

Background

Treatment of odontogenic infections includes surgical drainage and adjunctive antibiotics. This study was designed to generate efficacy and safety data to support twice daily dosing of amoxicillin/clavulanic acid compared to clindamycin in odontogenic infections.

Methods

This was a phase IV, randomised, observer blind study; 472 subjects were randomised to receive amoxicillin/clavulanic acid (875 mg/125 mg BID, n = 235) or clindamycin (150 mg QID, n = 237) for 5 or 7 days based on clinical response. The primary endpoint was percentage of subjects achieving clinical success (composite measure of pain, swelling, fever, and additional antimicrobial therapy required) at the end of treatment.

Results

The upper limit of two-sided 95% confidence interval for the treatment difference between the study arms (7.7%) was within protocol specified noninferiority margin of 10%, thus demonstrating noninferiority of amoxicillin/clavulanic acid to clindamycin. Secondary efficacy results showed a higher clinical success rate at Day 5 in the amoxicillin/clavulanic acid arm. Most adverse events (raised liver enzymes, diarrhoea, and headache) were similar across both arms and were of mild to moderate intensity.

Conclusion