se of antibiotic prophylaxis in the prevention of postoperative infection of third impacted mandibular molars

Phase 4

Completed

• Conditions: Postoperative surgical wound infection in helathy people; 'Impacted third molars; Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon; Infection - Other infectious diseases

• Registration Number: ACTRN12617001498381
• Lead Sponsor: Facultad de Odontología. Universidad de Chile

Brief Summary

Background: The objective of this study was to determine the effect of antibiotic prophylaxis in preventing postoperative infections after extraction of impacted mandibular third molars. Material and Methods: A Parallel-group, randomized, blind, placebo-controlled trial was performed. 154 patients were randomly allocated to 2 groups; experimental (n=77) receiving 2g amoxicillin 1 hour prior to surgery and control (n=77) receiving placebo. The primary outcome was postoperative infections, and the secondary outcome was the need for rescue analgesia. Results: 4.5% of patients developed postoperative infections, five patients of the control group (4 alveolar osteitis, 1 surgical site infection) and two of the experimental group (1 alveolar osteitis, 1 surgical site infection). The difference between groups was not statistically significant, RR=0.4 (95%CI 0.08-1.99, p=0.41) NNTB=26. Rescue analgesia intake was significantly higher in the control group (41 vs. 18 patients of experimental group) RR=0.49 (95%CI 0.32-0.75, p<0.05) NNTB=3. Conclusions: The use of 2g amoxicillin 1 hour before surgery was not effective in significantly reducing the risk of postoperative infections from impacted mandibular third molars extraction compared to placebo. Nevertheless, antibiotic prophylaxis was associated with a reduced need for rescue analgesia.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-10-24
• Study Completion: 2017-12-22
• Last Update Posted: 21 February 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

Healthy patients between 15 to 35 years old: Clinically and radiographically presence at least of one impacted mandibular third molar,

Exclusion Criteria

Pregnancy.
Allergy to penicillin and its derivatives.
Allergy to nonsteroidal anti-inflammatory drugs.
Patients with gastric ulcer.
Patients who have undergone any type of antibiotic treatment at least 30 days before surgery.
Patients with pericoronaritis episode up to 7 days before the intervention.
Patients with psychiatric illness.
Immunocompromised
Patients with addiction to narcotic drugs or illicit substances

Study & Design

• Study Type: Interventional
• Study Design: Not specified