Is perioperative antibiotic prophylaxis in the case of routine surgical removal of the third molar still justified? A randomized, double-blind, placebo-controlled clinical trial with a split-mouth design

Abstract

Introduction: Since antimicrobial resistance, caused by various factors including antibiotic overuse and abuse, is a severe challenge, the necessity of perioperative antibiotic prophylactic for surgical third molar removal remains a contentious topic. This study determined whether perioperative antibiotic prophylaxis can reduce surgical site infections (SSIs), swelling, and pain in the case of surgical removal of wisdom teeth.

Material and methods: A randomized, double-blind, placebo-controlled clinical trial with a split-mouth design. A study medication of 2 g amoxicillin, administered 1 h before the third molar removal, followed by 1.5 g each for the first 3 postoperative days, was compared with placebo medication. The primary outcome variable (SSI), secondary clinical parameters (swelling and trismus), and patient-centered outcome measures (bleeding, swelling, pain, and pain medication intake) were documented until postoperative day 7. Statistical analyses were done with a paired t test, t test for independent samples, Chi-square test, and McNemar test, including effect sizes.

Results: Primary outcome SSI, in total 11%, and clinical parameters swelling and trismus were not significantly different between the two groups. The patient-centered outcome measures (bleeding, swelling, and pain) did not significantly differ, except for postoperative bleeding in the EG on day 0. No significant result was found with pain medication intake postoperative on days 0-7.

Conclusions: Perioperative administration of oral antibiotics neither revealed additional benefits in patient-related outcome measures nor reduced postoperative complications compared with the placebo group indicated at routine surgical removal of noninflamed wisdom teeth.

Clinical relevance: Taking antimicrobial resistance into account, clear recommendations for administering drugs, particularly antibiotics, are critical in oral surgery.

Keywords: Antibiotics; Oral surgery; Perioperative antibiotic prophylaxis; Third molar surgery.

Fig. 1

CONSORT flow diagram showing the participant enrolment, with the number of participants randomized and the randomization process allocated to both interventions, dropouts, reasons for dropouts, and the number analyzed for outcome measures (SAE, serious adverse event; np, number of patients; ni, number of interventions; EG, event group; CG, control group)

Fig. 2

Secondary outcome variable swelling. Analog values by summarized tape measures in millimeters (lateral corner of the eye–jaw angle; tragus–lateral corner of the mouth, tragus–pogonion) were evaluated preoperatively (baseline) on a postoperative day 1 and day 7 in the event group (EG) and control group (CG). Resembled in mean with standard deviation (SD)

Fig. 3

Secondary outcome variable swelling. Face scans were recorded preoperatively on postoperative day 1 and day 7. Digitally analyzed in milliliters via superimposition with preoperative scan on days 1 and 7 in the event group (EG) and control group (CG). Resembled in mean with standard deviation (SD)

Fig. 4

Secondary outcome variable trismus. The change of interincisal distance (in millimeter) between values measured preoperatively and on postoperative day 1 and between day 1 and day 7 in the event group (EG) and control group (CG). Resembled in mean with standard deviation (SD)

Fig. 5

a–c Patient-centered outcomes bleeding, swelling, and pain. Mean values of postoperative bleeding, swelling, and pain on VAS from day 0 (day of surgery) until day 7. EG = dark, CG = light. a Day 0: significant difference between groups (p = 0.012). b–c No significant difference occurred by t test for independent samples

Fig. 6

Patient-centered outcomes pain medication intake. The number of patients needing pain medication intake was evaluated postoperatively from day 0 (day of surgery) until day 7. EG = dark, CG = light. No significant difference occurred in the McNemar test