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).
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.
Lacasa
J M
JM
Service of Internal Medicine, Hospital Mútua de Terrassa, University of Barcelona, Barcelona, Spain.
Jiménez
J A
JA
Ferrás
V
V
Bossom
M
M
Sóla-Morales
O
O
García-Rey
C
C
Aguilar
L
L
Garau
J
J
D000328:Adult; D000368:Aged; D019980:Amoxicillin-Potassium Clavulanate Combination / Q000008:administration & dosage*; D000900:Anti-Bacterial Agents / Q000008:administration & dosage*; D019072:Antibiotic Prophylaxis; D016022:Case-Control Studies; D003680:Deglutition Disorders / Q000517:prevention & control; D003692:Delayed-Action Preparations; D004311:Double-Blind Method; D004487:Edema / Q000517:prevention & control; D005260:Female; D005334:Fever / Q000517:prevention & control; D006801:Humans; D008297:Male; D008875:Middle Aged; D008964:Molar, Third / Q000601:surgery*; D010027:Osteotomy; D010149:Postoperative Pain / Q000517:prevention & control; D010919:Placebos; D011183:Postoperative Complications / Q000517:prevention & control*; D012307:Risk Factors; D013530:Surgical Wound Infection / Q000517:prevention & control; D014081:Tooth Extraction; D016896:Treatment Outcome; D014313:Trismus / Q000517:prevention & control
D000900:Anti-Bacterial Agents; D003692:Delayed-Action Preparations; D010919:Placebos; D019980:Amoxicillin-Potassium Clavulanate Combination