Prophylaxis versus pre-emptive treatment for infective and inflammatory complications of surgical third molar removal: a randomized, double-blind, placebo-controlled, clinical trial with sustained release amoxicillin/clavulanic acid (1000/62.5 mg)

• Published in: International journal of oral and maxillofacial surgery 2007-04, Vol.36 (4), p.321-327
• Main Authors: Lacasa, J.M, Jiménez, J.A, Ferrás, V, Bossom, M, Sóla-Morales, O, García-Rey, C, Aguilar, L, Garau, J
• Format: Article
• Language: English
• Subjects: Adult; Aged; Amoxicillin-Potassium Clavulanate Combination - administration & dosage; amoxicillin/clavulanic acid; Anti-Bacterial Agents - administration & dosage; Antibacterial agents; Antibiotic Prophylaxis; Antibiotics. Antiinfectious agents. Antiparasitic agents; Biological and medical sciences; Case-Control Studies; Deglutition Disorders - prevention & control; Delayed-Action Preparations; Dentistry; Double-Blind Method; Edema - prevention & control; Female; Fever - prevention & control; Humans; Male; Medical sciences; Middle Aged; Molar, Third - surgery; oral infection; Osteotomy; Otorhinolaryngology. Stomatology; Pain, Postoperative - prevention & control; Pharmacology. Drug treatments; Placebos; Postoperative Complications - prevention & control; Risk Factors; Surgery; Surgical Wound Infection - prevention & control; third mandibular molar removal; Tooth Extraction; Treatment Outcome; Trismus - prevention & control
• ISSN: 0901-5027; 1399-0020
• DOI: 10.1016/j.ijom.2006.11.007

Abstract The most common complications after surgical extraction of the third mandibular molar are trismus, oedema or swelling, local pain, dysphagia and infection. The aim of this comparative, double-blind, randomized clinical trial was to evaluate the efficacy of two sustained release amoxicillin/clavulanate regimens in the reduction of infection after third molar extractive surgery. A total of 225 patients were randomized into three equal groups: placebo, prophylaxis with single pre-surgical dose of two tablets amoxicillin/clavulanate 1000/62.5 mg, and pre-emptive post-surgery therapy with two tablets amoxicillin/clavulanate 1000/62.5 mg BID for 5 days. A higher rate of infection ( P = 0.006) was found among patients receiving placebo (16%) than those receiving single-dose prophylaxis (5.3%) or 5-day pre-emptive therapy (2.7%). A relationship between both the duration (13.8% for long versus 7.4% for medium versus 1.6% for short) and difficulty (12.7% with ostectomy versus 3.5% without ostectomy; P = 0.011) of surgical procedure and incidence of subsequent infection was also observed. Both prophylactic and therapeutic regimens versus placebo achieved greater reduction of pain after surgery on day 3 ( P = 0.001). Logistic regression analysis revealed a risk of infection of 24%, 9% and 4% for ostectomy with placebo, prophylaxis and pre-emptive treatment, respectively, whereas it was 7%, 2% and 1% if ostectomy was not performed. Pre-emptive therapy with the oral sustained release amoxicillin/clavulanate formulation reduced the rate of subsequent infection in patients undergoing ostectomy. Prophylaxis was beneficial in simpler procedures and may be indicated in cases where ostectomy is not performed.